Survey of chemical compounds in
consumer products
Survey no. 11 – 2002
Selected Plant Substances in “Natural” Cosmetics
Intecon a/s
Page 1 of 75
Page 2 of 75
1 Table of contents
1
TABLE OF CONTENTS
3
2
FOREWORD
9
3
SUMMARY
10
4
PROCEDURE
12
4.1
COLLECTION OF PRODUCTS
4.1.1
Definition of natural cosmetics
4.1.2
Purchase
4.2
IDENTIFICATION AND LISTING OF INGREDIENTS
4.3
SELECTION OF 20 PLANT OILS/EXTRACTS
4.4
LITERATURE SEARCH AND EVALUATION OF ALLERGENIC AND/OR SKIN
12
12
12
14
14
16
4.4.1
TOXLINE
16
4.4.2
CAplus (Chemical Abstract plus)
16
4.4.3
COSMOS at the Danish National Library of Science and Medicine –
University Library (DNLB)
16
4.4.4
MEDLINE
16
4.4.5
HSDB
17
4.4.6
RTECS
17
4.4.7
EMBASE (WebSPIRS)
17
4.4.8
GESTIS-Stoffendatenbank
17
4.4.9
ADISINSIGHT
17
IRRITANT PROPERTIES
5
PRODUCTION OF EXTRACTS/OILS
5.1
5.2
6
OILS
EXTRACTS AND TINCTURES
SUMMARY OF SEARCH RESULTS
6.1
PLANT EXTRACTS/OILS WITH A BASIS FOR EVALUATION
6.1.1
Arnica montana
6.1.2
Irritation
6.1.3
Phototoxicity
6.1.4
Evaluation
6.2
PRUNUS DULCIS
6.2.1
Allergy
6.2.2
Irritation
6.2.3
Phototoxicity
6.2.4
Evaluation
6.3
PRUNUS ARMENIACA
6.3.1
Allergy
6.3.2
Irritation
6.3.3
Phototoxicity
6.3.4
Evaluation
6.4
HAMAMELIS VIRGINIANA
6.4.1
Allergy
6.4.2
Irritation
6.4.3
Phototoxicity
18
18
18
19
19
19
19
19
19
20
20
20
20
20
20
20
20
20
20
20
20
20
21
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Evaluation
6.4.4
6.5
CHAMOMILLA RECUTITA
6.5.1
Allergy
6.5.2
Irritation
6.5.3
Phototoxicity
6.5.4
Evaluation
6.6
BUTYROSPERMUM PARKII
6.7
ALOE BARBADENSIS
6.7.1
Allergy
6.7.2
Irritation
6.7.3
Phototoxicity
6.7.4
Evaluation
6.8
CALENDULA OFFICINALIS
6.8.1
Allergy
6.8.2
Irritation
6.8.3
Phototoxicity
6.8.4
Evaluation
6.9
SIMMONDSIA CHINENSIS
6.9.1
Allergy
6.9.2
Irritation
6.9.3
Phototoxicity
6.9.4
Evaluation
6.10 GLYCINE SOJA
6.10.1
Allergy
6.10.2
Irritation
6.10.3
Phototoxicity
6.10.4
Evaluation
6.11 CITRUS AURENTIUM BERGAMIA, CITRUS MEDICA LIMONUM, CITRUS
AURENTIUS DULCIS, AND CITRUS NOBILIS
6.11.1
Allergy
6.11.2
Irritation
6.11.3
Phototoxicity
6.11.4
Evaluation
6.12 DAUCUS CAROTA
6.12.1
Allergy
6.12.2
Irritation
6.12.3
Phototoxicity
6.12.4
Evaluation
6.13 BISABOLOL
6.13.1
Allergy
6.13.2
Irritation
6.13.3
Phototoxicity
6.13.4
Evaluation
6.14 AESCULUS HIPPOCASTANUM
6.14.1
Allergy
6.14.2
Irritation
6.14.3
Phototoxicity
6.14.4
Evaluation
6.15 ANANAS SATIVUS
6.15.1
Allergy
6.15.2
Irritation
6.15.3
Phototoxicity
6.15.4
Evaluation
6.16 PERSEA GRATISSIMA
6.16.1
Allergy
6.16.2
Irritation
21
21
21
21
21
21
21
21
21
22
22
22
22
22
22
22
22
23
23
23
23
23
23
23
23
23
23
23
24
24
24
24
24
24
24
24
24
25
25
25
25
25
25
25
25
25
25
25
26
26
26
26
26
26
26
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Phototoxicity
6.16.3
6.16.4
Evaluation
6.17 TRITICUM VULGARE
6.17.1
Allergy
6.17.2
Irritation
6.17.3
Phototoxicity
6.17.4
Evaluation
7
26
26
27
27
27
27
27
DISCUSSION
7.1
7.2
7.3
28
WHICH SUBSTANCES ARE CONTAINED IN THE ACTUAL EXTRACT?
WHICH CHANGES DO THE SUBSTANCES UNDERGO?
EXPOSURE AND HUMAN INDIVIDUALITY
28
28
29
8
CONCLUSION
30
9
REFERENCES
32
10
LITERARY ANALYSIS
34
11
ARNICA MONTANA
35
11.1.1
11.1.2
11.1.3
11.1.4
11.1.5
11.1.6
11.1.7
12
PRUNUS DULCIS
12.1.1
12.1.2
12.1.3
12.1.4
12.1.5
12.1.6
12.1.7
13
Other names
Allergy
Irritation
Phototoxicity
Cases
Remarks
References
HAMAMELIS VIRGINIANA
14.1.1
14.1.2
14.1.3
14.1.4
14.1.5
14.1.6
14.1.7
15
Other names
Allergy
Irritation
Phototoxicity
Cases
Remarks
References
PRUNUS ARMENIACA
13.1.1
13.1.2
13.1.3
13.1.4
13.1.5
13.1.6
13.1.7
14
Other names
Allergy
Irritation
Phototoxicity
Cases
Miscellaneous
References
Other names
Allergy
Irritation
Phototoxicity
Cases
Miscellaneous
References
CHAMOMILLA RECUTITA
35
35
37
38
38
38
38
40
40
40
40
40
40
40
40
41
41
41
41
41
41
41
41
42
42
42
42
42
42
42
42
43
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15.1.1
15.1.2
15.1.3
15.1.4
15.1.5
15.1.6
15.1.7
15.1.8
16
BUTYROSPERMUM PARKII
16.1.1
16.1.2
16.1.3
16.1.4
16.1.5
16.1.6
16.1.7
17
Other names
Allergy
Irritation
Phototoxicity
Cases
References
GLYCINE SOJA
20.1.1
20.1.2
20.1.3
20.1.4
20.1.5
20.1.6
21
Other names
Allergy
Irritation
Phototoxicity
Cases
Miscellaneous
References
SIMMONDSIA CHINENSIS
19.1.1
19.1.2
19.1.3
19.1.4
19.1.5
19.1.6
20
Other names
Extracts
Allergy
Irritation
Phototoxicity
Miscellaneous
References
CALENDULA OFFICINALIS
18.1.1
18.1.2
18.1.3
18.1.4
18.1.5
18.1.6
18.1.7
19
Other names
Allergy
Irritation
Phototoxicity
Cases
Miscellaneous
References
ALOE BARBADENSIS
17.1.1
17.1.2
17.1.3
17.1.4
17.1.5
17.1.6
17.1.7
18
Other names
Allergy
Irritation
Phototoxicity
Cases
Miscellaneous
Remarks
References
Other names
Allergy
Irritation
Phototoxicity
Cases
References
CITRUS
21.1.1
21.1.2
21.1.3
Other names
Allergy
Irritation
43
43
44
44
44
44
44
44
46
46
46
46
46
46
46
46
47
47
47
48
48
48
49
49
51
51
51
52
53
53
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54
55
56
57
57
58
58
58
58
58
58
59
60
60
60
61
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Phototoxicity
Cases
Miscellaneous
References
62
62
62
63
DAUCUS CAROTA
64
21.1.4
21.1.5
21.1.6
21.1.7
22
22.1.1
22.1.2
22.1.3
22.1.4
22.1.5
22.1.6
22.1.7
22.1.8
23
BISABOLOL
23.1.1
23.1.2
23.1.3
23.1.4
23.1.5
23.1.6
23.1.7
24
66
66
66
66
66
67
67
67
68
68
68
68
68
68
68
68
68
ANANAS SATIVUS
70
Other names
Allergy
Irritation
Phototoxicity
Cases
Remarks
References
70
70
70
70
70
70
70
PERSEA GRATTISSIMA
71
26.1.1
26.1.2
26.1.3
26.1.4
26.1.5
26.1.6
26.1.7
27
64
64
64
64
65
65
65
65
Other names
Allergy
Irritation
Phototoxicity
Cases
Miscellaneous
Remarks
References
25.1.1
25.1.2
25.1.3
25.1.4
25.1.5
25.1.6
25.1.7
26
Other names
Allergy
Irritation
Phototoxicity
Cases
Miscellaneous
References
AESCULUS HIPPOCASTANUM
24.1.1
24.1.2
24.1.3
24.1.4
24.1.5
24.1.6
24.1.7
24.1.8
25
Other names
Allergy
Irritation
Phototoxicity
Cases
Miscellaneous
Remarks
References
Other names
Allergy
Irritation
Phototoxicity
Cases
Remarks
References
TRITICUM VULGARE
27.1.1
27.1.2
27.1.3
Other names
Allergy
Irritation
71
71
72
73
73
73
73
74
74
74
74
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27.1.4
27.1.5
27.1.6
27.1.7
27.1.8
Phototoxicity
Cases
Miscellaneous
Remarks
References
75
75
75
75
75
Page 8 of 75
2 Foreword
The Danish Environmental Protection Agency is making a special effort to map
chemical substances in consumer products. The purpose is to increase the level of
information and regulation in this field. One of the product groups that the Danish
Environmental Protection Agency has investigated is "natural cosmetics".
As part of this project attempts have been made to evaluate the allergenic, skin irritant, and phototoxic properties of 20 plant extracts/oils contained in creams marketed as "natural cosmetics". The investigation was based on literature searches.
Producers and importers have reviewed the report and commented on it before publication. Many of the comments have been incorporated into the report.
The various plant extracts/oils may contain different active substances. Some of
these substances can be avoided in the finished extract, depending on which parts
of the plant were used in the extracts and on various cleaning methods.
This is the reason why the substances contained in various plant extracts/oils may
differ although the extracts/oils are made from the same plant.
Producers go to great lengths to avoid potentially harmful active substances in the
extracts used in cosmetic products.
The problem to consumers may be that the declaration of contents does not state
clearly which parts of the plant have been used in the product nor the purity of the
plant extract/oil. Producers have this information so it is available if necessary.
The problematic substances often exist in small concentrations in the finished
products.
Page 9 of 75
3 Summary
This project has tried to evaluate, through literature search, allergenic, skin irritant,
and phototoxic properties of 20 plant extracts/oils contained in creams marketed as
natural cosmetics.
The 20 plant extracts/oils were selected in co-operation with the Danish Environmental Protection Agency on the basis of the ingredients in 50 creams bought at
Matas, The Body Shop, and Sundhedskost.
Literature about allergenic, skin irritant, and phototoxic properties was searched in
nine databases and reference works. Many ingredients in the individual extract being unknown, the search concentrated on ready plant extract/oils, not on the individual components. The results of the search are shown in Appendix B, stating
sources and giving a brief resume of the essential parts of the individual sources.
In the section "Summary of results" the allergenic, skin irritant, and phototoxic
properties of the plant extracts/oils are assessed on the basis of Appendix B. For
each extract/oil the most essential issues from the literature are summarised and assessed. The evaluation deals with the properties of the extracts/oils, not their application in cosmetic products.
Based on the limited amount of literature it was possible to assess the allergy potential of twelve oils/extracts, the irritation potential of ten, and the potential phototoxicity of six. Six of the examined oils/extracts could not be assessed.
The twelve oils for which it was possible to assess the allergy potential are:
• Arnica montana – potentially allergenic, with the sesquiterpene lactone helenalin and its derivates as most essential active ingredient
• Chamomilla recutita – potentially allergenic, with the linear sesquiterpene lactone anthecotulid as most essential active ingredient
• Aloe barbadensis – certain extracts – not including Aloe blad gel or Whole leaf
aloe – are potentially allergenic, with the anthraquinones alion and emodin as
most essential active ingredients
• Calendula officinalis – potentially allergenic
• Simmondsia chinensis – potentially allergenic to extremely sensitive persons
• Glycine soy – potentially allergenic in case of strong exposure (data taken from
occupational exposure)
• Citrus aurentium bergamia – potentially allergenic, with d-limonene as most essential active ingredient
• Citrus medica limonum - potentially allergenic, with d-limonene as most essential active ingredient
• Citrus aurentium dulcis - potentially allergenic, with d-limonene as most essential active ingredient
• Citrus nobilis - potentially allergenic, with d-limonene as most essential active
ingredient
• Daucus carota – raw carrot is considered to be potentially allergenic, but the extract could not be assessed
• Persea gratissima – fresh avocado is considered to be potentially allergenic; the
avocado oil is considered to be non-allergenic
Page 10 of 75
The ten of which the irritation potential could be assessed are:
• Arnica montana – non-irritant
• Aloe barbadensis – shortterm localirritant potential related to the fysiological effect ; increased blood cirkulation and astringent effect
• Calendula officinalis – non-irritant
• Simmondsia chinensis - non-irritant
• Citrus aurentium bergamia – irritant, d-limonene being the most essential active
ingredient
• Citrus medica limonum - irritant, d-limonene being the most essential active ingredient
• Citrus aurentium dulcis - irritant, d-limonene being the most essential active ingredient
• Citrus nobilis - irritant, d-limonene being the most essential active ingredient
• Daucus carota – raw carrot and carrot juice are considered to be irritant; the extract could not be assessed
• Triticum vulgare – non-irritant
The six products of which the phototoxicity could be assessed are:
•
•
•
•
Arnica montana – not phototoxic
Calendula officinalis – not phototoxic
Simmondsia chinensis – not phototoxic
Citrus aurentium bergamia (natural) – phototoxic due to its content of 5methoxypsoralene
• Citrus media limonum (natural) - phototoxic due to its content of 5methoxypsoralene
• Bisabolol – not phototoxic
Not all properties of the following oils/extracts could be assessed:
•
•
•
•
•
•
Prunus dulcis
Prunus armeniaca
Hamamelis virginiana
Bytoruspermum parkii
Aesculus hippocastanum
Ananas sativus
Different plant oils and extracts have been used for internal and external treatment
for many years. Based on the longstanding application and the few references
found, the allergy and irritation potential of the oils/extracts that could be assessed
is considered to be rather small. However, this does not apply to extremely sensitive persons like e.g. allergics.
Page 11 of 75
4 Procedure
The project was divided into conclusive phases. Some of the phases could be conducted simultaneously.
Phases:
1.
2.
3.
4.
Collection of products
Identification and listing of ingredients
Selection of 20 plant oils/extracts
Literature search and evaluation of allergenic, skin irritant, and phototoxic
properties properties
4.1 Collection of products
Natural cosmetics (or cosmetics marketed as such) include a wide range of products. In consultation with the Danish Environmental Protection Agency it was decided to focus on creams due to the fact that their contact with the skin lasts longer
than other typical "natural cosmetics" like shampoo and soap. This means increased skin exposure and thus increased risk of developing contact allergy.
4.1.1 Definition of natural cosmetics
Natural cosmetics have not hitherto been a firmly defined product group, but the
notion is used widely for all products containing natural ingredients. Besides, authorities' approvals of a product as a natural cosmetic product vary from country to
country. Therefore, the Council of Europe has published a common definition of
natural products. The following is a summary of this definition.
ƒ A product consisting of natural ingredients; i.e. natural substances including any
substance of botanical, animal, or mineral origin as well as mixtures hereof
ƒ By choice of raw materials the manufacturer must ensure that the ingredients
are no harmful to humans – especially with regard to allergenicity
ƒ The natural substances may only be derived and treated using physical methods
(e.g. extrusion, centrifugation, freezing, and drying), microbiological and enzymatic methods. The substances may be extracted in in water, ethanol, and other
suited, naturally produced solvents.
ƒ Only natural fragrances with names and definitions in line with the international
ISO 9235 standard may be used in natural cosmetics. Synthetically produced
ethereal oils, nature-identical perfumes, and chemically modified natural raw
materials may not be used in perfume mixtures characterised as natural.
ƒ Some preservatives (nature-identical substances) are permitted, provided that
they are referred to as preservatives on the packaging, and listed in Annex VI
part I of the Council Directive 76/768/ECC.
ƒ Emulgators made by hydrolysis esterification or re-esterification of fats and
oils, waxes, lecitines, lanoline, mono, olgo or polysaccarines, proteins, and
lipoproteins are permitted.
4.1.2 Purchase
Purchase of products for the present project did not lean on the definition by the
Council of Europe. This procedure was decided on the assumption that the majority
Page 12 of 75
of ordinary consumers do neither know the Council of Europe's definitions, nor do
they have sufficient knowledge to see if the products meet the definitions. Instead
we decided to use products, which in the retail trade appear as "natural" and of
which it may therefore be expected that ordinary consumers conceive them as such.
The 50 creams used were marketed as natural cosmetics by the following shops:
• Matas
• The Body Shop
• Sundhedskost
These shops are known for their trade with natural cosmetics.
4.1.2.1 Matas
Matas gathers several brands of "natural"/"natural cosmetic" products in special
corners of their shops. They have a wide selection of known brands. Moreover,
Matas have their own series of natural cosmetics, including shampoos, body shampoos, soaps, and several variants of creams. Matas own series is Swan labelled.
4.1.2.2 The Body Shop
The Body Shop has its own products made and sells them as purely "natural"/"natural cosmetic" products.
On its website the Body Shop describes itself in the following way: The Body Shop
is a value driven, high quality skin and body care retailer of cosmetics and skin and
body care products. Since 1976 the Body Shop has made a large number of customers aware that many natural ingredients are applicable for personal care, e.g.
bananas that are not only edible, but may also be used for washing your hair. In
1998/1999 they sold a product almost every 0.4 second, and their shops worldwide
have more than 84 million customer transactions. The present range includes 600
products and more than 400 different kinds of accessories. The Body Shop has always believed that business is primarily about human relationships.
4.1.2.3 Sundhedskost
The company Sundhedskost sells health foods, ecological foodstuffs, alternative
medicine, and "natural"/"natural cosmetic" products. Their product range includes
some of the known products as well as some more special ones. Some of Sundhedskost's reasons to deal with them are mentioned below:
• "Natural cosmetics" – natural shampoos, soaps, make-up, and other personal
hygiene products
• Non-allergenic products, because we do all we can to exclude artificial additives
from all our products: As close to nature as possible, as little industrial treatment as possible
There is no doubt that the 50 products do not form a complete list. All series include several variants: Some for the body, some for the face, and some for the
hands. Moreover, the creams are available with several different fragrances.
With the purchases made we seek to cover the widest possible spectre of plant
oils/extracts. Therefore, the number of products that contain the single oils/extracts
does not say how common they are. Still it is obvious that some ingredients are
used frequently, as they appear repeatedly as part of the "basis" in otherwise different creams.
Page 13 of 75
Other oils/extracts are not part of that many products. However, the products in
which they are found are then marketed specially by this ingredient.
The survey in Appendix A shows, which products are bought in which shop.
4.2 Identification and listing of ingredients
Creams are usually water-in-oil or oil-in-water emulsions. Different types of
products (creams, lotions, milks, pastes, etc.) are preferred, depending on the site of
application and purpose (care, cleaning, or decoration). Cosmetics typically consist
of 5-50 per cent fats (oil, fat, or wax), 1-10 per cent emulgators, and 50-90 per cent
hydrofil components (water and water-soluble ingredients) (Ullmann, A24, 1993).
The ingredients are identified by the statutory declaration on the packaging.
The ingredients are identified on the basis of the statutory declaration on the packaging. According to the law, the ingredients should be indicated by their INCI
names, but they are not for all purchased products. Instead, Latin and English
names are mentioned. Some manufacturers mention the Danish name in brackets
after the INCI name.
All ingredients (natural and/or synthetic) contained in the 50 products are listed in
a matrix. The matrix is structured in such a way that one side provides a list of ingredients, whereas the other side lists the products. The contents of the matrix indicate which ingredients are parts of which products.
The products are listed in such a way that each manufacturer's products are listed
collectively. This also indicates that some manufacturers obviously have favourite
ingredients and thus market a lot of almost identical products. This is probably due
to the fact that all of the creams are based on a single basic cream.
Based on the matrix the applied plant oils/extracts are listed by the number of
products, in which they are contained. The matrix and the list of plant extracts/oils
are both available electronically as Appendix C.
4.3 Selection of 20 plant oils/extracts
All 20 plant oils/extracts have been selected by the Danish Environmental Protection Agency before evaluating their allergenic or skin irritant properties.
The oil/extracts were selected on account of the number of products they occur in,
as they are all estimated as ordinarily applied plant oils/extracts in spite of the reservation made in paragraph 4.1.2 This does not mean that the others are not commonly used – only that the number of oils/extracts used in this project is limited to
20.
Page 14 of 75
The following plant oils/extracts were selected:
Plant oil/extract
Prunus armeniaca (apricot kernel)
Buxus chinensis (jojoba, Simmondsia chinensis)
Calendula officinalis (marigold)
Glycine soja (soybean)
Aloe barbadensis (Aloe vera)
Butyrospermum parkii (shea nut)
Prunus dulcis (almond)
Arnica montana (leopards bane)
Chamomilla recutita (chamomile)
Persea gratissima (avocado)
Citrus nobilis (mandarin)
Hamamelis Virginiana (witch hazel)
Triticum vulgare (wheat)
Ananas sativus (pineapple)
Aesculus hippocastanum (horse chestnut)
Bisabolol*
Citrus bergamia (bergamot, Citrus aurentium bergamia)
Citrus dulcis (orange, Citrus aurentium dulcis)
Citrus limon (lemon, Citrus medica limonum)
Daucus carota oil (carrot)
Number of products in
which they appear
17
15
9
9
8
8
8
7
7
6
5
5
5
4
4
4
4
4
4
4
* Bisabolol is a pure substance that occurs in a natural form in various plants.
The tables show the names of the plant oils/extracts mentioned on the packaging.
The English name is given in brackets together with the INCI name if this is not
mentioned on the packaging.
As appears from the table, most INCI names do not indicate whether the products
is an oil or an extract. Neither does it say from which part of the plant the
oil/extract is derived. The latest version of the INCI list includes INCI names,
which do define this, but only in relation to few of the purchased products. However, some manufacturers mention in brackets after the INCI name whether the
product is an oil or an extract.
Of the 20 oils/extracts, the following are said to be oils: Prunus armeniaca, Simmondsia chinensis, Glycine soya, Bytrospermum parkii, Prunus dulcis, Persea gratissima, Triticum vulgare, Daucus carota. From the INCI list it appears that several
of them are also available as extracts of various kinds, and as such they may appear
in other products.
The following are on the packaging, said to be extracts: Calendula officinalis,
Chamomilla recutita. It is not stated whether they are extracted in water, alcohol,
ether, or some other medium like e.g. oil.
As for the others: Aloe barbadensis, Arnica montana, Citrus nobilis, Citrus aurentium bergamia, Citrus aurentium dulcis, and Citrus medica limonum, Ananas sativus, and Aescula hippocastanum, it is not mentioned on the packaging whether
they are extracts or oils.
Page 15 of 75
Bisabolol is not a plant extract like the others, but a pure substance that may be derived from several different plants. It is particularly found in large concentrations
in camomile, but is also derived from other plants.
4.4 Literature search and evaluation of allergenic and/or skin irritant properties
The characteristic properties of essential oils and plant extracts may be due to either one single component or a number of components. For example it has not yet
been possible to reproduce the fragrance of e.g. coffee or chocolate. However,
analyses show that their fragrances consist of more than 700 components (D.
Siegler, 1998).
Given the fact that plant extracts/oils may consist of a large number of components,
we decided to search for the actual extract/oil, not the individual ingredients. If, in
some cases, a characteristic ingredient may be of major importance, it has been described.
We searched for information on allergy, irritation, and phototoxicity of the 20 plant
oils/extracts in a number of databases and reference books. The databases are the
ones we usually use for evaluating chemicals. In order to ensure that all relevant
data is used, we discussed the choice of databases and libraries with experts from
the Royal Veterinary and Agricultural University and the Royal Danish School of
Pharmacy. The following databases were used:
4.4.1 TOXLINE
TOXLINE (Toxicology Literature Online) is a bibliographical database published
by the U.S. National Library of Medicine. The database covers pharmacological,
biochemical, physiological and toxicological effects of drugs and chemicals.
4.4.2 CAplus (Chemical Abstract plus)
Like Chemical Abstract, Chemical Abstract plus covers international magazines
(also purely electronic ones), patents, technical reports, books, and conference publications in the fields of chemistry, biochemistry, and other related natural sciences
since 1967. Moreover, Chemical Abstract plus contains biographical articles, book
reviews, leading articles, lists of errata, letters to editors, and minutes of meetings.
When searching in Chemical Abstract, the focus was on toxicology.
4.4.3 COSMOS at the Danish National Library of Science and Medicine –
University Library (DNLB)
COSMOS is DNLB's electronic catalogue of publications dating back to 1970.
DNLB is the Danish main subject library and Copenhagen's university library for
natural and health sciences.
4.4.4 MEDLINE
MEDLINE (Medical Literature, Analysis, and Retrieval System Online) is the primary bibliographical database of the U.S. National Library of Medicines and contains more than 11 million references, its main focus being on biomedicine. The articles are described in an English excerpt.
Page 16 of 75
4.4.5 HSDB
HSDB (Hazardous Substances Data Bank) is a factual non-bibliographic database
under the Toxicology Information Programme of the National Library of Medicine.
It contains toxicological and environmental information on chemicals. Data comes
from standard texts, monographs, government documents, technical reports, and
magazines.
4.4.6 RTECS
RTECS (Registry of Toxic Effects and Chemical Substances) is a factual database
containing toxicity data and references for commercial products, e.g. drugs and agricultural chemicals. The National Institute compiles the information for Occupational Safety and Health, which is an office under the U.S. Department of Health
and Human Services. The files contain names, classification, CAS numbers, structural charts, toxicological data, etc.
4.4.7 EMBASE (WebSPIRS)
Biomedical pharmacological bibliography covering the period from 1980 till now.
It includes European magazines and has an extensive indexation of bibliography.
Electronic version of Excerpta Medica.
4.4.8 GESTIS-Stoffendatenbank
The database contains information concerning safe occupational handling of
chemicals, including effects on humans, recommended protective measures and
first-aid. It also states physical/chemical data. The data contains information on approximately 7,000 substances. The database is published by the German Berufsgenossenschaftliches Institut für Arbeitssicherheit.
4.4.9 ADISINSIGHT
Adis R&D Insight contains full-text reports and drug profiles that are being actively researched in the pharmaceutical industry. New drugs are added to the database when the first laboratory results come up, and they are followed until they are
released on the market. All revelations on the product's way towards the marked
are evaluated and reported. The files contain information about generic name,
synonyms, trade names, CAS nos., name of developer, licences obtained, tests, and
bibliographical references.
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5 Production of extracts/oils
The composition of plant oils/extracts depends on several factors, e.g. the part of
the plant applied, the geographical origin of the plant (factors like soil composition
and climate are important), and the manufacturing process.
To facilitate the understanding of notions used, we have described the different
methods of production of extracts/oils. The predominant methods for deriving
cosmetic raw materials from plants are: Distillation, mechanical separation (pressing), and extraction (Ullmann, A11, 1988).
5.1 Oils
Pressing plant material in hydraulic presses makes non-volatile oils and waxes. Essential oils (volatile oils) may be derived in several ways, depending on the plant
material and stability of the oil. Oils of e.g. cinnamon, clove, and peppermint oils
are distilled with water, water and steam, or directly with steam. Other volatile oils
such as "lemon grass" oil that breaks down if distilled are manufactured by pressing. Rolling the fruit over a vat with sharp “spikes” produces lemon oils. Hereby
the oil drops accumulate in the vat. The content of volatile oils from flower petals
is often so small that it cannot be derived on a large scale. In these cases neutral oil
is placed on a glass plate and subsequently covered with flower petals. Once it has
absorbed as much fragrance as possible, the oil is removed and extracted with alcohol (Lovell, 1993).
The output of essential oils by distillation ranges from a few tenths of a percent to
few percent (Ullmann, A11, 1988).
5.2 Extracts and tinctures
Extracts are produced by extraction in different kind of solvents like water, alcohol
solutions, or propyleneglycole. The extracts are often concentrated, and it is common to use the concentrated substance in its solid form (Council of Europe, 1994).
An extract typically contains large quantities of non-volatile substances, which are
not found in essential oils made by distillation (Ullmann, A11, 1988).
Materials often referred to as "plant extracts" may be produced simply by macerating the plant material in water (Lovell, 1993) or some other suited solution (Council of Europe, 1994). These are often called tinctures. As opposed to extracts they
are not being concentrated.
As the present oils and extracts may be produced in different ways and from different parts of the plant, the composition may vary from product to product. Consequently, an allergen that is found in a water-based extract is not necessarily also
found in the oil or in an ethanol-based extract. This may make it very difficult to
assess a product merely on the basis of the INCI name on the packaging.
Page 18 of 75
6 Summary of search results
This chapter summarizes the results of the search for individual plant extracts/oils.
It should be emphasized that the assessment relates to the individual oils and extracts. As discussed in the next section, the results of the assessment are not necessarily coinciding with the properties of the oil/extract when used in "natural cosmetics".
Appendix B contains data sheets for each single plant extract/oil. The data sheets
contain references and a brief review of each source's contents relating to allergy,
irritation, and phototoxicity. Reference is made to these data sheets for details
about the sources. In cases where the source refers to other sources for information,
the author's name is stated in brackets after the information in Appendix B's quote
of the material
6.1 Plant extracts/oils with a basis for evaluation
The data material on Arnica montana is rather comprehensive; most of it relates to
the extract (Arnica tincture), whereas the others relate to the plant itself.
6.1.1 Arnica montana
Results for allergenic properties are conflicting. However, several investigations
and five cases show that Arnica allergy exists.
A woman, for instance, developed dermatitis after repeated treatments with Arnica
tincture, and an assistant nurse developed dermatitis after longstanding use of massage oil containing Arnica. Both were patch-tested positive.
Several sources have found the active substances to be sesquiterpene lactones, and
through experiments with guinea pigs Hausen et al. have demonstrated that the
substance sesquiterpene lactone helenalin in particular and its derivates are powerful sensitizers. This substance though is only present in very small amount in Arnica so other sensitizers may be present as well.
Several sources have demonstrated a cross reaction to other plants of the compositae family.
6.1.2 Irritation
The sources found agree that Arnica montana extract is slightly or non-irritant to
the skin.
6.1.3 Phototoxicity
The few sources found agree that Arnica montana is not phototoxic.
6.1.4 Evaluation
Based on the findings Arnica montana is evaluated as a sensitizer, but as nonirritant and non-phototoxic.
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6.2 Prunus dulcis
Only very little material about Prunus dulcis could be found.
6.2.1 Allergy
Prunus dulcis is described by two sources only, which make conflicting statements.
6.2.2 Irritation
No data was found about the skin irritant properties of Prunus dulcis.
6.2.3 Phototoxicity
No data was found about the phototoxic properties of Prunus dulcis.
6.2.4 Evaluation
There is not sufficient basis to evaluate the allergenic, irritant and phototoxic properties of prunus dulcis.
6.3 Prunus armeniaca
6.3.1 Allergy
No clinical data could be found, but one single case of occupational allergy to fresh
apricot kernels is mentioned.
6.3.2 Irritation
No data was found about the skin irritant properties of Prunus armeniaca.
6.3.3 Phototoxicity
No data was found about the phototoxic properties of Prunus armeniaca.
6.3.4 Evaluation
There is not sufficient basis to evaluate the allergenic, irritant and phototoxic properties of Prunus armeniaca.
6.4 Hamamelis virginiana
Very few sources could be found about Hamamelis virginiana.
6.4.1 Allergy
One single source has conducted experiments with Hamamelis virginiana. However, the findings are uncertain because of the possible interaction with the applied
basic ointment.
6.4.2 Irritation
No sources were found that mention irritation due to Hamamelis virginiana.
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6.4.3 Phototoxicity
No sources were found that mention the phototoxic properties of Hamamelis virginiana.
6.4.4 Evaluation
The basis for evaluation of Hamamelis virginiana is insufficient.
6.5 Chamomilla recutita
Quite a lot of sources mention Chamomilla recutita. Most of them relate to the extract.
6.5.1 Allergy
The sources found agree that Chamomilla is a sensitizer. This is supported by three
cases that show that Chamomilla allergy exists. However, findings from clinical
tests would be desirable to support this.
Several sources have demonstrated that the active sensitizising substance is an anthecotulid, a linear sesquiterpene lactone which is only present in small amounts.
Moreover, the sources mention other sorts of chamomile (Degumille), which do
not contain this substance. Tests with this sort demonstrated much less sensitiztion.
6.5.2 Irritation
No sources were found describing the skin irritant properties of Chamomilla.
6.5.3 Phototoxicity
No data was found about the phototoxicity of Chamomilla.
6.5.4 Evaluation
Based on the findings Chamomilla recutita is assessed as potentially allergenic,
with the sesquiterpene lactone anthecotolid as the active substance. There is not
sufficient basis to assess whether Chamomilla recutita is skin irritant or phototoxic.
6.6 Butyrospermum parkii
No data on Butyrospermum parkii have been found to allow an assessment of allergenic, skin irritant, and phototoxic properties.
6.7 Aloe barbadensis
6.7.1 Allergy
The sources found agree that certain Aloe barbadensis Mill. extracts may be allergenic. Only few cases have been described, and seen in the light of the widespread
use, the risk of allergy should be regarded as small.
The allergen is believed to be anthraquinone aloin and emodin.
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6.7.2 Irritation
Several sources mention slight irritation. They mention a short burning or pricking
sensation right after application, which usually goes away within 30 minutes.
These reactions are ascribable to the Aloe gel’s astringent effect and its stimulating
effect on blood circulation.
6.7.3 Phototoxicity
Only one source mentions briefly an unpublished test involving 20 subjects, and
the most important result was prolongation of the achieved pigmentation.
6.7.4 Evaluation
Certain extracts of Aloe barbadensis Mill. are, on the existing basis, found to be
potentially allergenic, although the very low number of cases reported should be
seen in the light of the very widespread use. The allergen is believed to be anthraquinones, meaning that the risk of allergy is not present in anthraquinone-free
extracts (Aloe leaf gel and Whole leaf aloe).
There is a risk of slight irritation (burning/pricking sensation) immediately after
application of Aloe vera gel. The sensation is ascribable to the product’s effect (astringent effect and stimulating effect on blood circulation), but it goes away within
30 minutes after application.
The existing basis is not sufficient to evaluate whether different Aloe barbadensis
extracts have phototoxic properties.
6.8 Calendula officinalis
Quite a lot of data could be found about Calendula officinalis extract and a few
about the plant itself.
6.8.1 Allergy
Clinical test results are conflicting, but demonstrate that allergy occurs, though in a
few cases only.
A cross-reaction between plants of the compositae family and a mix of sesquiterpene lactones has been demonstrated.
6.8.2 Irritation
Findings by sources describing clinical tests are negative. A single source mentions
that both plant and tincture are irritants, but no background data is submitted.
6.8.3 Phototoxicity
Only few data are available about phototoxicity – all show negative results.
6.8.4 Evaluation
Based on the available data Calendula officinalis is assesses as potentially allergenic, but not as skin irritant or phototoxic.
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6.9 Simmondsia chinensis
Quite a lot of sources mention Simmondsia chinensis oil and jojoba alcohol. But all
relate to the same source.
6.9.1 Allergy
Several tests were conducted without demonstrating allergic relations. However,
five of six persons, who were suspected of being sensitive, were tested with Simmondsia chinensis and developed an allergic reaction.
6.9.2 Irritation
Tests conducted all show no reaction or slight irritation.
6.9.3 Phototoxicity
No phototoxic effects were observed in tests with jojoba alcohol and products containing jojoba oil.
6.9.4 Evaluation
It is assessed that extremely sensitive persons may develop allergy, but Simmondsia chinensis is assessed as non-irritant and non-phototoxic.
6.10 Glycine soja
Only few sources are available, and most of them mention occupational cases.
6.10.1 Allergy
Allergy is described in soybean workers.
Another case describes allergic reaction to a facial cream containing soybean extract.
6.10.2 Irritation
No sources were found that describes skin irritation due to Glycine soja.
6.10.3 Phototoxicity
No sources were found that describes the phototoxic properties of Glycine soja.
6.10.4 Evaluation
It is assessed that strong exposure to Glycine soja may induce allergy. Its skin irritating and phototoxic potential cannot be assessed on the basis of available material.
6.11 Citrus aurentium bergamia, Citrus medica limonum, Citrus aurentius dulcis, and Citrus nobilis
Almost all data are about the oils from the peel of citrus fruits.
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6.11.1 Allergy
All sources agree that citrus fruits contain d-limonene. Several sources demonstrate
that oxided d-limonene is allergenic, whereas information on unoxided d-limonene
is conflicting.
6.11.2 Irritation
One source mentions the irritation potential of the acid content, but that may be adjusted in cosmetics.
D-limonene is classified as skin irritant. Another source also mentions d-limonene
as irritant.
6.11.3 Phototoxicity
Several sources mention that natural Citrus aurentium and Citrus medica limonum
contains 5-methoxypsoralene that is phototoxic.
5-methoxypsoralene is not allowed in cosmetics.
6.11.4 Evaluation
All four citrus oils are evaluated as potentially allergenic and skin irritant, with dlimonene as the active substance. Moreover, natural Citrus aurentium bergamia oil
and Citrus medica limonum oil are evaluated as phototoxic because of their 5methoxypsoralene content which is present in the peel of the citrus fruits.
6.12 Daucus carota
The data available mainly relate to fresh carrot and carrot juice.
6.12.1 Allergy
Several cases of allergy to fresh carrot are mentioned. One source mentions a test
in which only five of 26 carrot allergics reacted to carrot extract, whereas all reacted to fresh carrot.
One source mentions farnicol as the active substance, but the data on which this is
based are not available.
6.12.2 Irritation
Only few data exist on irritation, but one source mentions carrot juice as a frequent
reason for irritation in the food industry.
6.12.3 Phototoxicity
Several sources mention phototoxic activity, but no test data is presented. Only one
of the sources mentions whether raw carrot or carrot extract was used.
6.12.4 Evaluation
Raw carrot is assessed as allergenic, and its juice probably as irritant. There is no
basis to assess whether carrot extract is allergenic or irritant.
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6.13 Bisabolol
6.13.1 Allergy
Only two sources were found mentioning allergy in connection with Bisabolol.
One of the sources describes a case where a woman developed allergy to a facial
cream containing bisabolol. The other source describes a test with 25 persons; none
of them showed allergic reactions.
6.13.2 Irritation
Only two sources were found; their findings are conflicting.
6.13.3 Phototoxicity
Only one source was found, describing two tests for phototoxicity of Bisabolol. No
reactions were found.
6.13.4 Evaluation
The present basis is not sufficient to assess the allergy or irritation potential. Findings from phototoxicity tests seem to indicate that it is not phototoxic.
6.14 Aesculus hippocastanum
6.14.1 Allergy
No clinical data was found on the allergenic properties of Aesculus hippocastanum.
However, two cases describe contact urticaria and dermatitis due to extracts of
horse chestnut. In one of the cases aescin was the active substance.
6.14.2 Irritation
One case mentions itching in connection with horse chestnut extract. A patch test
showed that esculin was the active substance.
6.14.3 Phototoxicity
No sources were found describing the phototoxic properties of Aesculus hippocastanum.
6.14.4 Evaluation
The data available does not provide sufficient basis to evaluate the allergenic, skin
irritant, and phototoxic properties of Aesculus hippocastanum. Still it could be interesting to further examine the substances asculin and aesin contained in horse
chestnuts.
6.15 Ananas sativus
Only few sources were found about Ananas sativus.
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6.15.1 Allergy
One source and one case were found that mention allergy in connection with Ananas sativus. Both refer to bromelain as the active substance.
6.15.2 Irritation
Occupational skin irritation due to bromelain content in juice is mentioned.
6.15.3 Phototoxicity
No sources were found that describe phototoxicity in connection with Ananas sativus.
6.15.4 Evaluation
The available data do not provide sufficient basis to assess the allergenic, irritant,
and phototoxic properties of Ananas sativus, but a more detailed examination of
bromelain would be interesting.
6.16 Persea gratissima
Quite a lot of test data mention Persea gratissima oil – the main part is from the
same source – and a few relate to fresh avocado.
6.16.1 Allergy
Two groups of 17 and 100 persons, respectively, who had allergy besides food allergy, were tested with fresh Persea gratissima. 17 persons of one group and 21 of
the other had allergic reactions.
Tests with Persea gratissima oil show no sensitiztion, but one source reports possible cases of sensitization.
6.16.2 Irritation
The available results that all come from the same source show conflicting findings.
The source believes that the reactions are due to other components in the tested
products, but this is not confirmed. The source mentions another test, where 100
women are tested negative to pure Persea gratissima oil.
6.16.3 Phototoxicity
No sources are found that mention phototoxic properties of Persea gratissima.
6.16.4 Evaluation
Fresh avocado is assessed to be allergenic based on the available sources, whereas
Persea gratissima oil does not seem to be allergenic. The skin irritation potential of
Persea gratissima could not be evaluated because of conflicting findings. The phototoxicity potential as well could not be evaluated for the same reason.
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6.17 Triticum vulgare
6.17.1 Allergy
Only a few sources could be found, and they give conflicting results. The sources
mentioning Triticum vulgare as allergenic do so on the background of its contents
of alpha-tocopherol that is said to be a contact allergen.
6.17.2 Irritation
The sources found agree that Triticum vulgare is not or only slightly irritant.
6.17.3 Phototoxicity
There is no data available to assess the phototoxic properties of Triticum vulgare.
6.17.4 Evaluation
The present basis is not sufficient to assess whether Triticum vulgare is allergenic,
although its content of alpha-tocopherol should be further examined. Triticum vulgare is assesses as non-irritant. Its phototoxic properties could not be assessed on
the present basis.
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7 Discussion
Although they have been used for many years, literature on allergenic, irritant, and
phototoxic properties of plant extracts and oils are scarce. The obtained information found is often conflicting. The allergy potential could be evaluated in 12 out of
the 20 examined oils/extract; potential irritant effects could be assessed on ten, and
the phototoxic potential could be assessed in six.
Still, the evaluation is made with the reservation that many external factors decide
whether a potentially allergenic plant extract/oil actually constitutes a risk when
used in cosmetic products. These factors are discussed in the following paragraphs.
7.1 Which substances are contained in the actual extract?
As described in section 4.4 a plant extract may consist of several hundreds of different chemical connection. Of a large number of different combinations one or
few pure substances may be the reason of allergy, e.g. helenalin and its derivates in
Arnica montana, d-limonene in citrus fruit, and anthocoluid in Chamomilla recutita.
Section 5 describes production of extracts and oils. Whether an extract or oil is allergenic or not may depend on the production method. For both the oil and the extract, the extraction media may greatly influence which substances are extracted.
For instance is it possible that the oil and an alcohol extract from a plant is allergenic, whereas the aqueous extract is harmless, because the active allergen is insoluble in water.
The INCI name alone does not indicate how the oil/extract has been produced and
maybe modified. Therefore it is not possible to know either whether any sensitizing
ingredients have been added to the cosmetic product. However, it is a progress that
– for some plants – the new INCI list shows whether the product is an extract or an
oil and from which part of the plant it is derived.
7.2 Which changes do the substances undergo?
As claimed by several sources, the oils/extracts may change on their way, so the allergenic substance may not be present in the cosmetic product. On the other hand,
reactions like these may also cause allergens. Examples are:
• One source (Arnica montana, source 1) has tested human beings in clinical tests
with a basic ointment to which extract had been added. An allergenic subject
who is known to be allergenic to one of the extracts reacted to the extract only
and not to the ointment. Something in the basic ointment effects no reaction.
One possibility is that a substance in the basic ointment reacts with the allergen
or encapsulates it, thereby making it inactive.
• According to sources D-limonene is not sensitizing itself, however, the oxidation products are. D-limonene may have oxidised during the manufacturing process or in the container, or it may oxidise directly on the skin.
Page 28 of 75
7.3 Exposure and human individuality
Direct knowledge of people' reactions often stems from cases where persons have
had allergic reactions and went to the doctor, and where the reason is referred to a
plant extract/oil. In many of these cases substance contact was part of the person's
work; in these cases the persons have been massively exposed to the substance
over a long period of time. This exposure is not directly comparable with the exposure from cosmetics. Other cases are about multi-allergy-suffers who are particularly sensitive to new allergens and thus show extreme reactions.
One source (Simmondsia chinensis, source 2) has demonstrated allergic reactions
in persons, who are known to be allergic to other substances, whereas no reaction
could be seen in a control group of non-allergic subjects. Generally, reactions are
observed more frequently in tests with allergics than in tests with non-allergic persons. This indicates that allergic persons are particularly sensitive.
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8 Conclusion
Twelve of the oils/extracts examined could be assessed for their allergy potential;
ten could be assessed for their irritant properties, and six of them could be assessed
for the phototoxicity potential. Six of the examined oil/extracts could not be assessed.
The twelve oils for which it was possible to assess the allergy potential are:
• Arnica montana – potentially allergenic, with the sesquiterpene lactone helenalin and its derivates as most essential active ingredient
• Chamomilla recutita – potentially allergenic, with the linear sesquiterpene lactone anthecotulid as most essential active ingredient
• Aloe barbadensis – certain extracts – not including Aloe blad gel or Whole leaf
aloe – are potentially allergenic, with the anthraquinones alion and emodin as
most essential active ingredients
• Calendula officinalis – potentially allergenic
• Simmondsia chinensis – potentially allergenic to extremely sensitive persons
• Glycine soy – potentially allergenic in case of strong exposure (data taken from
occupational exposure)
• Citrus aurentium bergamia – potentially allergenic, with d-limonene as most essential active ingredient
• Citrus medica limonum - potentially allergenic, with d-limonene as most essential active ingredient
• Citrus aurentium dulcis - potentially allergenic, with d-limonene as most essential active ingredient
• Citrus nobilis - potentially allergenic, with d-limonene as most essential active
ingredient
• Daucus carota – raw carrot is considered to be potentially allergenic, but the extract could not be assessed
• Persea gratissima – fresh avocado is considered to be potentially allergenic; the
avocado oil is considered to be non-allergenic
The ten of which the irritation potential could be assessed are:
• Arnica montana – non-irritant
• Aloe barbadensis – shortterm localirritant potential related to the fysiological effect ; increased blood cirkulation and astringent effect
• Calendula officinalis – non-irritant
• Simmondsia chinensis - non-irritant
• Citrus aurentium bergamia – irritant, d-limonene being the most essential active
ingredient
• Citrus medica limonum - irritant, d-limonene being the most essential active ingredient
• Citrus aurentium dulcis - irritant, d-limonene being the most essential active ingredient
• Citrus nobilis - irritant, d-limonene being the most essential active ingredient
• Daucus carota – raw carrot and carrot juice are considered to be irritant; the extract could not be assessed
• Triticum vulgare – non-irritant
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The six products of which the phototoxicity could be assessed are:
•
•
•
•
Arnica montana – not phototoxic
Calendula officinalis – not phototoxic
Simmondsia chinensis – not phototoxic
Citrus aurentium bergamia (natural) – phototoxic due to its content of 5methoxypsoralene
• Citrus media limonum (natural) - phototoxic due to its content of 5methoxypsoralene
• Bisabolol – not phototoxic
Not all properties of the following oils/extracts could be assessed:
•
•
•
•
•
•
Prunus dulcis
Prunus armeniaca
Hamamelis virginiana
Bytoruspermum parkii
Aesculus hippocastanum
Ananas sativus
Different plant oils and extracts have been used for internal and external treatment
for many years. Based on the longstanding application and the few references
found, the allergy and irritation potential of the oils/extracts that could be assessed
is considered to be rather small. However, this does not apply to extremely sensitive persons like e.g. allergics.
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9 References
Council of Europe: Plant preparations used as ingredients of cosmetic products, 1.
version 1994
Lovell, Christopher R.: “Plants and the Skin”, Blackwell Scientific Publications, 1.
version, 1993
Siegler, David S.: “Plant Secondary Metabolism”, 1. version., 1998
Ullmann’s Encyclopedia of Industrial Chemistry, VCH Verlagsgesellschaft mbH,
Volume 11, 5. version, 1988
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Page 33 of 75
10 Literary analysis
The specific plantoils/-extracts are examined further in the following chapters.
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11 Arnica montana
INCI names
Arnica montana
Arnica montana extract
CAS no.
68990-11-4
11.1.1 Other names
Leopards bane, mountain tobacco, mountain snuff, wolfs bane, flores arnica
11.1.2 Allergy
Patients were tested with five ointments in six different prick test clinics in the
Netherlands (1,032 patients). The ointments were based on petrolatum, liquid paraffin (20 per cent), wool fat, and chlorophyll (1 per cent). One of the five ointments
contained 10 per cent Arnica montana tincture. There was no detected reaction to
the ointment; however, one patient known to be an Arnica allergic reacted strongly
to the extract without the "basic ointment". Therefore, other components in the
product may influence the result (1).
A modified Magnusson-Kligman test was conducted with ten Harley guinea pigs.
A concentration of 5 per cent Arnica montana extract was used during induction.
One week after induction, a "booster" of 10 per cent sodium lauryl sulphate was
applied. 24 hours later undiluted Arnica montana extract was applied to the same
site for 48 hours under an occlusive patch. The animals were challenged two weeks
after the booster with 5 and 10 per cent Arnica montana extract in petrolatum.
None of the ten animals showed any signs of sensitisation (CTFA 1981) (2).
The sensitisation potential of a mixture consisting of Arnica montana extract (1 – 5
per cent), soybean (Glycine soja) oil (> 50 per cent), and tocophenol (< 1 per cent)
was determined in a test using ten white guinea pigs. A group of five guinea pigs
was used as a control. The hair was clipped, and 0.5 ml of the mixture was applied
to the test site for ten days. Following a 14-day non-treatment period, the test material was applied to a previously untreated site on both test and control animals. No
signs of irritation were observed and the mixture was not a sensitizer (2).
An induction dose of 25 per cent Arnica absolute was applied to 20 albino guinea
pigs. A group of ten guinea pigs was used as control. The test animals were challenged with 1 per cent, 3 per cent, and 10 per cent Arnica absolute and the control
animals were challenged with 3 per cent and 10 per cent Arnica absolute. No effects were observed after challenge (2).
The sensitisation potential of the raw extract and the Arnica tincture was evaluated
using a concentration of 0.5 per cent in 25 guinea pigs. All animals were sensitised
indicating that Arnica montana is a very strong sensitizer. Only three out of eight
different sesquiterpene lactones contained in Arnica montana act as contact allergens. Testing guinea pigs used in the previous test with one per cent concentrations
Page 35 of 75
of helenalin and helenalinacetate showed a response to helenalin that was four
times as strong as the response to the helenalinacetate (4).
The contact allergens are sesquiterpene helenalin, helenalinacetate, and methacrylate (5).
The same components contained in Arnica montana also occur in other plants.
Therefore, "cross allergies" may occur causing allergic reactions to other plants of
the compositae family (5).
There are examples of people working with the Arnica montana flower, have become allergic; Wrangsjö et al. 1990 mention contact allergy from random contact
with the flowers (6).
Arnica montana supplies an Arnica tincture made from the entire plant, including
its roots that were known to cause dermatitis already in the 20th century. Arnica
may cause erythema and swelling where applied, furthermore, it may induce eczema (Fox 1873). A potentially allergenic (Mitchell and Dupuis 1971) sesquiterpene lactone (Zakharov et al. 1971) is derived from the plant (7).
The active components in Arnica montana and sesquiterpene lactones mostly act as
anti-irritants. Consumption may be fatal. External use is primarily harmless, but
dermatitis to sesquiterpene lactones is common (9).
191 subjects with contact dermatitis were patch tested in a sensitisation test with
the "European standard series" and a number of cosmetic ingredients, including a
ten per cent Arnica extract in alcohol. The test material was applied over two days.
The test sites were scored 20 minutes, one day and two days after removal of the
patch. One person reacted positively to the Arnica extract (de Groot et al. 1988)
(2).
A compositae mix consisting of a short ether extract of 0.5 per cent Arnica montana and other species was included in a standard series and patch tested using
3,851 subjects over a 5-year period (Hausen, 1996). The mix was applied to the
back of each patient for 24 hours, and the sites were scored according to the International Contact Dermatitis Research Group (ICDRG). If a positive reaction was
observed, extracts of the individual species were tested one week later. 118 patients
(3.1 per cent), 44 males, and 74 females, had a positive reaction to the mix; it was
determined that 33 of these patients acquired this hypersensitivity occupationally.
44 (51.8 per cent) of 85 patients tested with the individual species reacted to Arnica
montana. Ten of the 85 subjects that were retested reacted only to Arnica montana.
A patch test was performed according to the methods of the ICDRG with the European standard series and some compositae allergens, including 0.5 per cent Arnica
in petrolatum, using 15 subjects. The compositae allergens were applied for 24
hours, and the test sites were scored after 20 and 60 minutes and 48 and 96 hours.
Arnica, as the plant extract, produced positive results in three subjects and with the
Arnica pollen it produced positive results in two subjects (Wrangsjö, Ros, and
Wahlberg, 1990) (2).
Commercial-grade resinoid of Arnica, 1 per cent in petrolatum, was applied to
three subjects that were "contact-sensitive" to numerous compositae species and
sesquiterpene lactone and to six eczema patients. No positive reactions were observed. One reason may be that the commercial extracts could have been free of
significant amounts of the sesquiterpene lactone (Rodriques and Mitchell, 1977)
(2).
Page 36 of 75
A sesquiterpene lactone mix, in 0.1 per cent petrolatum, was included in a standard
patch test series and 686 patients were patch-tested with the series. 79 patients who
had positive reactions to the mix or who were suspected of having a compositae
dermatitis were tested with a compositae mix, in 6 per cent petrolatum including a
0.5 per cent ether extract of Arnica montana. The test materials were applied under
occlusive patches to the backs of the patients, and the sites were scored on days
two, three, or four, and sometimes on days five to seven, according to the ICDRG.
31 patients experienced positive reactions to one or both mixes. 23 of 32 patients
with Compositae allergy were patch-tested with 0.5 per cent Arnica, but no positive
reactions were observed. One patient was photo patch-tested with Arnica; a positive reaction was not seen (Paulsen, Andersen, and Hausen, 1993) (2).
11.1.3 Irritation
Nine rabbits were patch-tested with a 50 per cent Arnica extract at 5 per cent concentration in corn oil and an undiluted 50 per cent Arnica extract. Practically no irritation was observed.
A mixture of Arnica montana extract (1-5 per cent), Glycine soja (> 50 per cent)
and tocopherol (< 0.1 per cent) as a 0.1 per cent paraffin concentration was applied
on six white rabbits with clipped hair. One side of the back was abraded; the other
was intact. A dose of 0.5 ml was applied to each side over 24 hours. No signs of irritation were observed (2).
A group of six rabbits was used to determine the irritation potential of a face cream
containing 1 per cent Arnica montana extract. The cream was slightly irritating; the
PII (primary irritation index) was 1.7 (Ichimaru Pharcos Co. Ltd., 1995) (2).
The irritation potential of 5 per cent to 50 per cent Arnica absolute (very pure) in
an 80 per cent ethanol / 20 per cent distilled water was determined using four
guinea pigs. The test materials were applied to the flank of each animal for six
hours under an occlusive patch. The sites were scored for irritation 24 and 48 hours
after patch removal. Slight patchy to moderate erythema was observed with 5 per
cent, ten per cent, and 25 per cent Arnica Absolute and slight patchy erythema was
observed with 50 per cent Arnica absolute. (RIFM, 1996) (2).
The irritation potential of 0.5 per cent to 100 per cent Arnica absolute in diethyl
phthalate was determined using four guinea pigs per dose; four patches were placed
on each animal. No effects were observed with 0.5 and 1 per cent. Slight patch erythema was observed in one animal with 2.5 per cent. With 5 and 10 per cent slight
patchy erythema was observed in two animals after 24 hours. 25 per cent caused
slight to moderate patchy erythema, and 50 per cent caused slight patchy erythema.
100 per cent gave slight patchy erythema (RFIM, 1996) (2).
Twenty microclines of 75 per cent Arnica absolute were placed under the dorsal
skin of six male mice. No irritation was observed after four, 24, and 48 hours
(RIFM, 1996) (2).
Six male mice were used to determine the irritation potential of 20 per cent Arnica
resinoid in triethyl citrate (RIFM, 1996) – no irritation was observed (2).
No skin-irritant effect of Arnica is seen in the case of aqueous extracts, as they do
not contain easily evaporating oils (Morrow, 1887) (7)
Page 37 of 75
11.1.4 Phototoxicity
20 microliters Arnica montana absolute in methanol were applied to six mice. The
test site was irradiated with a Xenon arc lamp for 30 minutes. A second group was
irradiated with a black light lamp. Methanol and 8-methoxypsoralen were used as
the negative and positive controls. No phototoxic effects were observed with 75 per
cent Arnica absolute (RFIM, 1996) (2).
20 per cent Arnica resinoid in triethyl citrate were applied to six mice. One group
was irradiated with a Xenon arc lamp, another with a black light lamp. No effects
were observed (RFIM, 1996) (2).
Undiluted Arnica resinoid was applied to six hairless mice, and the test sites were
irradiated for 60 minutes with a Xenon lamp. Another group was irradiated with a
black light lamp. Methanol and 8-methoxypsoralen were used as the negative and
positive controls. No phototoxic effects were observed (2).
11.1.5 Cases
A woman had treated a wound of her knee many times with a tincture of Arnica.
She developed a bullous dermatitis at the application site. A 6-year-old girl had
hurt herself and was treated by her mother with the Arnica tincture. After some
days she developed a severe contact dermatitis. In both patients positive patch tests
were obtained with Arnica montana ether extract and the tincture.
For the years 1844 to 1977 more than 35 publications can be cited from the literature, dealing with contact dermatitis due to the plant, but mostly due to the Arnica
tincture.
Over a three-year period, a 28-year-old nurse massaged her patients with Arnicabased massage oil. She developed eczema - first in her palms, then on the back of
her hands and finally on her underarm. It eventually turned into a serious weeping
dermatitis. She tested positive to the oil in a patch test, whereas the control test was
negative.
A 77-year-old patient returned time and again with eczema after having treated
himself with Arnica. A test showed strong reaction to Arnica tincture and Arnica
massage oil (5).
A 65-year-old hobby gardener had chronic eczema in his face and on his hands. He
reported recurrence after he had used fertilizer and treated his plants. Patch tests
with the International Contact Dermatitis Group standard series showed positive
reactions to sesquiterpene lactones 0.1 per cent in petrolatum, Arnica tincture 20
per cent in petrolatum, and captafol 20 per cent in petrolatum. The symptoms completely vanished during the winter (8).
11.1.6 Miscellaneous
Arnica montana is classified as recommended for use by the Council of Europe (3).
11.1.7 References
1. Bruynzeel, D.P.; van Ketel, W.G.; Young, E.; van Joost, Th.; Smeenk, G. –
Contact sensitisation by alternative topical medicaments containing plant extracts – Contact Dermatitis 1992 Vol. 27, pp. 278
Page 38 of 75
2.
3.
4.
5.
6.
7.
8.
9.
Cosmetic Ingredient Review Expert Panel, Monice Zondlo Fiume – Final report on the safety Assessment of Arnica Montana Extract and Arnica Montana
– International Journal of Toxicology 20(suppl.2); 1-11, 2001
Council of Europe – Plant preparations used as ingredients of cosmetic products, 1. edition, 1994
Hausen, B.M. – Identification of the allergens of Arnica Montana – Contact
Dermatitis (1987) Vol. 4, pp.308
Hausen, B.M. – Arnikaallergie – Der Hautartzt 31, pp. 10-17, 1980.
Hörmann, H.P.; Korting, H.C. – Evidence for Efficacy and Safety of Topical
Herbal Drugs in Dermatology: Part I: Anti-inflammatory agents – Phytomedicine Vol. 1/1994, pp. 161-171
Mitchell, John; Rook, Arthur – Botanical Dermatology – plant and plant products injurious to the skin – Vancouver Greenglass Ltd. 1979, pp.188-189
Spettoli, E; Silvani, S: Lucente, P; Guerra, L; Vincenzi, C – Contact dermatitis
caused by sesquiterpene lactones - American Journal of Contact Dermatitis
1998 March; 9(1), pp. 49-50
Williamson, John S.; Wyandt, Christy M. – Herbal Therapies: The facts and
the fiction – Drug Topics August 4, 1997
Page 39 of 75
12 Prunus dulcis
INCI name
Prunus amygdalus dulcis extract
Prunus amygdalus dulcis meal
Prunus amygdalus dulcis oil
Prunus amygdalus dulcis protein
Prunus amygdalus dulcis seed extract
CAS no.
90320-37-9
8007-69-0
90320-37-9
12.1.1 Other names
Sweet almond, almond
12.1.2 Allergy
Based on data and clinical experiments (58 references) sweet almond oil (different
sorts of prunus) and meal (degreased p. amygdalus and p. communis kernels) are
evaluated as non-irritant and sensitizing to the skin (1).
Five patients with occupational contact dermatitis from spices were investigated.
All were kitchen or restaurant or coffee room workers. The patients were patch
tested with fresh foodstuffs and spices and prick tested with 20 other allergens. Patient number four was patch tested clearly positive to almond (2).
12.1.3 Irritation
No data available
12.1.4 Phototoxicity
No data available
12.1.5 Cases
No data available
12.1.6 Remarks
Source 1 - awaiting publication
12.1.7 References
1.
2.
Cosmetic Ingredient Review Expert Panel – Final report on the safety assessment of sweet almond oil and almond meal – J. Am. Toxicol. (1983) 2(5), pp.
85-99. – abstract
Kanerva, Lasse; Estlander, Tuula; Jolanski, Ritta – Occupational allergic contact dermatitis from spices. Contact dermatitis 1996, 35, pp.157-162
Page 40 of 75
13 Prunus armeniaca
INCI name
Prunus armeniaca extract
Prunus armeniaca juice
Prunus armeniaca kernel extract
Prunus armeniaca kernel oil
Prunus armeniaca leaf extract
Prunus armeniaca seed powder
CAS no.
68650-44-2
68650-44-2
68650-44-2
72869-69-3
68650-44-2
-
13.1.1 Other names
Apricot
13.1.2 Allergy
No data available
13.1.3
Irritation
No data available
13.1.4 Phototoxicity
No data available
13.1.5 Cases
A 19-year-old girl got eczema from working in a marzipan factory for six weeks.
The symptoms disappeared after treatment and three weeks off work, but returned
immediately when she took up work again. She was prick tested with almond mass,
almonds, spices and apricot kernel – all with negative result. RAST with almond,
hazel nut, walnut, and cocoa nut gave negative results as well. RAST means Radio-Allergo-Sorbent-Test, and is an examination showing whether the blood contains antibodies (IgE) to certain allergens. An open test with almond paste, almond
spices, and peeled apricot kernels on the skin of her back gave positive results to
the apricot kernels. She developed erythema. The erythema appeared but ten minutes after removal of the test material and persisted for 20 minutes. The test sites
itched (1).
13.1.6 Remarks
Source 1 - awaiting publication
13.1.7 References
Goransson, K – Contact urticaria to apricot stone – Contact Dermatitis 1981; 7(5);
pp.282 – abstract
Page 41 of 75
14 Hamamelis virginiana
INCI names
Hamamelis virginiana distillate
Hamamelis virginiana extract
Hamamelis virginiana water
CAS no.
84696-19-5
84696-19-5
84696-19-5
14.1.1 Other names
Witch hazel
14.1.2 Allergy
1,032 patients were tested with five ointments in six prick test clinics. The bases of
the ointments were petrolatum, liquid paraffin (20 per cent), wool fat, and chlorophyll (1 per cent). One of the five ointments contained a 25 per cent solution of
Hamamelis extract. No positive reaction to Hamamelis was observed. However,
the researchers have some hesitations about the result, as they believe the basic
ointment may have influenced the result, because one of the ointments contained
Arnica, and a known Arnica allergic, who was tested, did not react to the ointment
containing Arnica, but only to the extract (1).
14.1.3 Irritation
No data available
14.1.4 Phototoxicity
No data available
14.1.5 Cases
No data available
14.1.6 Miscellaneous
Hamamelis virginiana is classified as recommended for use by the Council of
Europe (2).
14.1.7 References
1.
2.
Bruynzeel, D.P.; van Ketel, W.G.; Young, E.; van Joost, Th.; Smeenk, G. –
Contact sensitisation by alternative topical medicaments containing plant extracts – Contact Dermatitis 1992 Vol. 27, pp. 278
Council of Europe – Plant preparations used as ingredients of cosmetic products, 1st edition, 1994
Page 42 of 75
15 Chamomilla recutita
INCI names
Chamomilla recutita extract
Chamomilla recutita oil
Chamomilla recutita water
CAS no.
84082-60-0
8002-66-2
-
15.1.1 Other names
Camomile, Matricaria recutita, Matricaria chamomilla
15.1.2 Allergy
1,032 patients were tested with five ointments in six prick test clinics. The bases of
the ointments were petrolatum, liquid paraffin (20 per cent), wool fat, and chlorophyll (1 per cent). One of the five ointments contained a four per cent solution of
Matricaria chamomilla tincture. Two patients experienced positive reactions to the
test and to the control test with the pure tinctures as well. However, the researchers
have some hesitations about the result, as they believe the basic ointment may have
influenced the result, because one of the ointments contained Arnica, and a known
Arnica allergic, who was tested, did not react to the ointment containing Arnica,
but only to the extract (1).
Chamomile is a potential sensitizer, as allergic contact dermatitis has been observed in subjects handling the plant or using it as compresses or ointments
(Mitchel and Rook 1979) (3).
Some plant components may give dermatological side effects after use, among
them Chamomilla that may elicit allergic contact dermatitis (Van Ketel 1987) (4).
Two chamomile variants were compared in a test. It was demonstrated that the
moderate sensitizing effect of Chamomilla recutita came from its content of anthecotulid that is a linear sesquiterpene lactone that is present in small amounts. Degumille proved to be slightly sensitizing (Hausen et al. 1984) (6).
Literature cites but five cases which can definitely be ascribed to Matricaria
chamomille (Hausen et al.1984), and Van Ketels (1987) reported a case of allergy
in a part-time flower dealer. One allergen that has been positively demonstrated is
the sesquiterpene lactone desacetylmatricarine (Moslein, 1963) (7).
Allergy to chamomile is a serious problem, especially in Eastern European countries. The purpose of the study was to demonstrate whether anthecotulid-free extracts of Chamomilla recutita - KamillosanR - are potentially contact allergenic.
982 patients with contact dermatitis were tested with KamillosanR. Only one patient had an allergic reaction. This result seems to indicate that KamillosanR may
safely be used in cosmetics and medicine (9).
Page 43 of 75
15.1.3 Irritation
No data available
15.1.4 Phototoxicity
No data available
15.1.5 Cases
A 23-year-old woman tested positive to German chamomile (Matricaria chamomilla) in a patch test. A subsequent oral challenge test with undiluted chamomile
tea caused generalized pruritus of the face (5).
A 26-year-old woman with a past history of nickel intolerance presented with facial
eczema. Four days earlier she had dyed her eyebrows and immediately felt pruritus
in the area, and so applied Furacin® (nitrofurazone). The erythema worsened and
eczema enveloped the whole face. (8.). Testing with GEIDEC standard series and
Furacin® showed positive reactions to nickel, palladium, and a sesquiterpene lactone mix. Simultaneously with Furacin the patient had used a fermentation of Matricaria chamomile. Patch testing with an infusion 1:100 w/v and a plant series gave
a positive reaction to German chamomilla (Matricaria chamomilla) and a negative
reaction to Roman chamomile (Anthemis nobilis). The reaction to Matricaria
chamomile is ascribed to sesquiterpene lactones (8).
A 37-year-old woman gave a two-week history of three episodes of facial swelling.
At the time of consultation, her skin was normal. She was patch tested to a standard
and facial series, together with her own cosmetics. A positive reaction to a cosmetic containing 12.5 per cent plant extracts was obtained. Sesquiterpene lactone
mix (0.1 per cent pet.) and costus oil (1 per cent pet.) were both negative. Testing
the individual ingredients produced a positive patch test to Bisabolol (1 per cent
pet: Purity 87-93 per cent) only. The impurities in the sample of Bisabolol were:
Bisabolene, bisabololoxide, farnesol, nerolidol, and chamazulene. Patch tests in 30
controls were negative. This may be because Matricaria recutita may contain up to
50 per cent Bisabolol (10).
15.1.6 Miscellaneous
Matricaria chamomilla is classified as Recommended for use by the Council of
Europe (2).
15.1.7 Remarks
Sources 4, 6, and 7 refer to the same two sources and do not include details on the
circumstances.
Source 9 - awaiting publication
15.1.8 References
1.
2.
3.
Bruynzeel, D.P.; van Ketel, W.G.; Young, E.; van Joost, Th.; Smeenk, G. –
Contact sensitisation by alternative topical medicaments containing plant extracts – Contact Dermatitis 1992 Vol. 27, pp. 278
Council of Europe – Plant preparations used as ingredients of cosmetic products, 1. edition, 1994
Cronin, Etain – Contact Dermatitis – Churchill Livingstone 1980, pp.116
Page 44 of 75
4.
Ernst, E. – Adverse effects of herbal drugs in dermatology – Br. J. Dermatol.
2000 Nov; 143(5); 923-929
5. Foti, C.; Nettis, E.; Panebianco, R.; Cassano, N.; Diaferio, A. and Pia, D.P. –
Contact urticaria from Matricaria chamomilla – Contact Dermatitis 2000, 42,
360-361
6. Hörmann, H.P.; Korting, H.C. – Evidence for the Efficacy and Safety of Topical Herbal Drugs in Dermatology: Part I: Anti-inflammatory Agents – Phytomedicine Vol. 1/1994, pp. 161-171
7. Lovell, Christopher R. – Plants and the Skin – Blackwell Scientific Publications 1993, pp. 170-171
8. Rodriguez-Serna, M.; Sánchez-Motilla, J.M.; Ramón, R. and Aliaga, A. – Allergic and systemic contact dermatitis from Matricaria chamomilla tea – Contact Dermatitis 1998, 39, 192-193
9. Rudzski, E; Jalblonska, S. – KamillosanR is a safe product of camomile for
topical application: Results of patch testing consecutive patients with contact
dermatitis – Journal of Dermatological Treatment 2000, 11 (3), pp.161-163 abstract
10. Wilkinson, S.M.; Hausen, B.M. and Beck, M.H. – Allergic contact dermatitis
from plant extracts in a cosmetic – Contact Dermatitis 1995, 33, 58
Page 45 of 75
16 Butyrospermum
parkii
INCI names
Butyrospermum parkii butter
Butyrospermum parkii butter extract
Butyrospermum parkii butter unsaponifiables
CAS no.
91080-23-8
91080-23-8
225234-14-0
16.1.1 Other names
Shea butter
16.1.2 Allergy
No data available
16.1.3 Irritation
No data available
16.1.4 Phototoxicity
No data available
16.1.5 Cases
No data available
16.1.6 Miscellaneous
Shea butter is produced from the nuts of the shea nut tree that grows on the African
savannah. Africans use the butter/fat for cooking, as ointment, for body care and
hair, and for the production of soap. Contrary to other plant oils, the oil of shea
nuts has a high content of non-saponifiable fats that is of great importance to its
skin-friendly properties (1).
16.1.7 References
1.
Olberg, Helmuth – Schibutter – Seifen-Öle- Fette-Wachse, 113.ig. Nr.
10/1987, 333-334.
Page 46 of 75
17 Aloe barbadensis
INCI names
Aloe barbadensis
Aloe barbadensis extract
Aloe barbadensis flower extract
Aloe barbadensis gel
CAS no.
85507-69-3
17.1.1 Other names
Aloe barbadensis is the only permitted name in the EU, and the name covers all
possible extracts from Aloe barbadensis Mill.
The names Aloe leaf gel, Aloe vera gel or Aloe vera are also used instead of Aloe
barbadensis gel. Whole leaf gel is another extract covered by this name. Aloe extract is also a frequently used name and covers Aloe barbadensis extracts, etc.
General:
Seen in the light of the widespread use of drugs based on Aloe barbadensis, the
number of reported cases with unwanted side effects seems low. However, more
clinical evaluations are recommended due to the widespread use (1).
17.1.2 Extracts
Description of leaf structure:
The leaves of Aloe barbadensis Mill. are thick. They are made up of an outer hard
green leaf skin covering tubules in which yellow sap containing anthraquinones
runs. The sap runs when the leaves are cut in half (exudate). The leaves have a core
of a colourless gel-like substance (gel).
Below, focus will be on the content of anthraquinones as they are important components in connection with the reported unwanted side effects. Most cosmetic
products contain the anthraquinone-free extracts Aloe leaf gel or Whole leaf aloe.
Aloe leaf gel:
The gel is obtained by manual removal of the leaf skin and the tubules containing
the yellow sap, and the remaining colourless gel can be used directly or after one of
several possible stabilisation processes. The gel does not contain anthraquinones or
only traces of them.
Whole leaf aloe:
The aloe is obtained by processing whole leaves, followed by micro-filtering and
removal of anthraquinones by means of activated carbon. The aloe does not contain
anthraquinones.
Aloe extract:
Various extracts are made from Aloe leaves. The anthraquinone content varies.
Page 47 of 75
Aloe or bitter aloe:
The powder is made by drying collected exudate (i.e. yellow sap). The powder is
brown with a bitter smell and a bitter taste. The content of anthraquinones is high.
The powder is used as a laxative.
17.1.3 Allergy
Some plant substances may have dermatological side effects, among them certain
extracts from Aloe barbadensis Mill. In a single patient, Aloe vera proved to cause
serious allergic dermatitis following treatment on skin where the top layer was removed (2). Clinical trials, where the top skin layer was also removed, have shown
that none of the 18 subjects tested developed contact dermatitis. On the contrary,
the skin treated seemed to heal well (3).
Allergic contact dermatitis was also proved through patch test of one person following long-term consumption and application of a crushed gel-like substance
made from the pure Aloe plant. The reaction was comparable to the reaction
achieved from the use of 5% anthraquinone (4).
Those exposed to the risk of dermatitis are primarily persons handling the plant at
the raw material producers’ as they come in contact with all leaf parts when and/or
after cutting the leaves.
In addition to the two cases outlined above, one case has been reported where allergic dermatitis was seen in other places than the place of application. Allergic
dermatitis was established following treatment of stasis dermatitis with gel from an
Aloe vera plant. A subsequent patch test turned out positive for the gel, Quaternium 15 and formaldehyde (5).
One factor that may be of importance in the cases above is the presence of anthraquinones as pollution of the gel stemming from the yellow exudate (6).
A potential reason for sensitisation is the aloin anthraquinone, and in one isolated
case of allergic dermatitis, the reason for sensitisation was the emodin anthraquinone (7).
17.1.4 Irritation
In addition to the allergic reactions described above, only minor irritative reactions
are described, which are attributable to the effect of Aloe gel (increased blood circulation and an astringent effect).
A pricking or burning sensation may be experienced after application of Aloe vera
gel, but it usually goes away after 30 minutes (3), (8). Moreover, there are reports
of local pain, experienced initially after contact in connection with the treatment of
shin wounds. The pain is caused by improved blood circulation due to the effect of
the gel (6).
A low-molecular component extracted from the gel proved in vitro to have cytotoxic effects like those of aloin. The low-molecular component can probably be ascribed to the presence of yellow exudate in the gel (9).
17.1.5 Phototoxicity
An unpublished patch test conducted with 20 subjects, who were tested with an
Aloe vera product and placebo and then exposed to UV radiation, is very briefly
Page 48 of 75
described. The most important result was that the pigmentation of the patch-tested
areas lasted for more than one year (10). This one source does not suffice to document any toxic effect.
17.1.6 Miscellaneous
Aloe vera is classified as “recommended for use” by the Council of Europe (11).
17.1.7 References
1.
Hörmann, H.P.; Korting, H.C. – Evidence for the Efficacy and Safety of Topical Herbal Drugs in Dermatology: Part I: Anti-inflammatory Agents – Phytomedicine Vol. 1/1994, pp. 161-171.
2. Ernst, E. – Adverse effects of herbal drugs in dermatology – Br. J. Dermatol.
2000 Nov; 143(5); 923-929.
3. Fulton J.E.; Stimulation of postdermabrasion wound healing with stabilized
Aloe vera gel-Polyethylene oxide dressing; Journal of Dermatologic surgery
and oncololgy; 1990; 16; 5; 460-467.
4. Morrow D.M. et al.; Hypersensitivity to Aloe; Archives of Dermatology; Sept.
1980; Vol. 116; pp. 1064-1065.
5. Hogan D.J.; Widespread dermatitis after tropical treatment of chronic leg ulcers and stasis dermatitis; Canadian Medical Association Journal; 1988; 138;
336-338.
6. Reynolds, T; Dweck, A.C. – Aloe vera leaf gel: a review update – Journal of
Ethnopharmacol 1999 Dec. 15; 68(1-3): 3-37.
7. Mitchell, John; Rook, Arthur – Botanical Dermatology – plant and plant products injurious to the skin – Vancouver Greenglass Ltd. 1979, pp. 438-439.
8. Mantle, D. et al.; Adverse and beneficial effects of plant extracts on skin and
skin disorders; Adverse Drug React. Toxicol. Rev 2001, Oxford University
Press; 20(2) 89-103.
9. Avila H. et al.; Cytotoxicity of low molecular weight fraction from Aloe vera
(Aloe barbadensis Miller) gel; Tooxicon. 1997; 35(9); 1423-1430.
10. Dominquez-Soto L.; Photodermatitis to Aloe vera; International Journal of
Dermatology; 1992; vol. 31; no.5; 372.
11. Council of Europe – Plant preparations used as ingredients of cosmetic products, 1. edition, 1994.
Page 49 of 75
Page 50 of 75
18 Calendula officinalis
INCI names
Calendula officinalis
Calendula officinalis extract
Calendula officinalis oil
CAS no.
84776-23-8
70892-20-5
18.1.1 Other names
Marigold
18.1.2 Allergy
Patients were tested with five ointments in six different prick test clinics (1,032 patients). The ointments were based on petrolatum, liquid paraffin (20 per cent), wool
fat, and chlorophyll (1 per cent). One of the five ointments contained 10 per cent
Calendula officinalis tincture. No reaction was seen to the ointment in any of the
patients. However the researchers have hesitations about the result, as they believe
the basic ointment may have influenced the result, as one patient who was known
to be an Arnica allergic did not react to the ointment containing Arnica, but reacted
strongly to the extract. Therefore, other components in the product may influence
the result
The sensitization potential of Calendula officinalis was determined in a maximization test using 10 guinea pigs. Intradermale injections of 0.5 ml of aqueous
Freund's Complete Adjuvant (FCA), 5 per cent Calendula officinalis extract in
propylene glycol, and 50 per cent aqueous FCA were made to sites on the upper
back of each animal. A control group of ten animals received the injections without
the test material. One week after the injection, 20 per cent Calendula officinalis extract was applied to the induction site for 24 hours under an occlusive patch. Two
weeks after application, the animals were challenged with five and ten per cent Calendula officinalis extract that was applied under an occlusive patch. The challenge
sites were grade 24 and 48 hours after patch removal. Calendula officinalis extract,
five and ten per cent, did not produce a sensitisation reaction. (2).
The sensitization potential of a 50 per cent aqueous solution of a mixture containing Calendula officinalis extract, butylenes glycol, and water was determined in a
maximization test using guinea pigs. (Chemisches Laboratorium Dr. Kurt Richter
GmbH, 1996). No erythema or oedema were observed (2)
Calendula officinalis contains quercetine, saponines, and sesquiterpene lactones
(Steinegger and Hänsel, 1988). Hausen, 1988, mentions two cases including one in
which a patient grew Calendula officinalis and made topicals from it. Contact allergy after contact with the plant in nature has been reported in one case (Wrangsjö, 1990) (4).
An eye cream containing one per cent Calendula officinalis was tested on 109 humans. 0.1 per cent was applied under an occlusive patch for 24 hours at a test site
Page 51 of 75
on the back three days a week for test duration of three weeks. After two weeks
without application a new patch was applied in the same site for 24 hours. The
challenge site was graded after 24 and 48 hours. Erythema was not observed, so the
eye cream is not a sensitizer (2).
119 subjects with contact allergic dermatitis were tested with the European standard series with a number of cosmetic products containing ten per cent Calendula
officinalis extract in alcohol. The test material was applied for two days under a
patch and scored 20 minutes, one day and two days after removal of the patch. The
Calendula extract gave a positive reaction in one person (2).
A patch test was performed using 15 subjects with the European standard series
and some compositae allergens, including ten per cent Calendula extract in an
ointment and the pure components in the basic ointment. The allergens were applied for 24 hours, and the test sites were scored after 20 and 60 minutes and 48
and 96 hours. Calendula, both the plant extract and with pollen, produced a positive
result in one of the 15 subjects. The Calendula flower was tested, fresh and deep
frozen for six months. Both produced a positive reaction in one patient (2).
Commercial-grade absolute of Calendula, one per cent in petrolatum, was applied
to three subjects that were contact-sensitive to numerous compositae species and
sesquiterpene lactones and to six eczema patients (Rodriquez and Mitchel, 1977).
No positive reactions were observed.
A sesquiterpene lactone mix, 0.1 per cent petrolatum, was included in a standard
patch test series and 686 patients were patch tested with the series (Paulsen, Andersen, Hausen, 1993). 79 patients who had positive reactions to the mix or who were
suspected of having compositae dermatitis were tested with a compositae mix, six
per cent petrolatum. The test materials were applied under occlusive patches to the
backs of the patients, and the sites were scored on days two, three, or four, and
sometimes on days five to seven. 31 patients had positive reactions to one or both
of the mixes. One patient with compositae allergy had no reaction to ten per cent
Calendula officinalis (2).
18.1.3 Irritation
A ten per cent aqueous solution of Calendula officinalis extract was applied to the
skin of nine rats under an occlusive patch (CTFE, 1983). The primary irritation index (PII) was 0.0, i.e. the product is non-irritant (2).
An eye cream containing one per cent Calendula officinalis extract was tested in a
test under occlusive patches (CTFA, 1986). The irritation was minimal (2).
A mixture of Calendula officinalis extract (1-5 per cent), Glycine soja (>50 per
cent), and tocopherol (<1 per cent) was tested in liquid paraffin on rabbits. The
product was non-irritant (2).
A mixture of Calendula officinalis extract, butylene glycol and water was used in a
test. 0.5 ml of the mixture was applied to the intact and to abraded skin of six rabbits (Ichimaru Pharcos Co. Ltd., 1994). The application site was scored after two,
24, and 48 hours. Very slight erythema was observed after four hours. The mixture
was also applied to five guinea pigs in 19 portions of 0.5 ml each over four weeks.
No oedema or erythema was observed (2).
Irritation is ascribed to both the Calendula officinalis plant itself and tinctures
(Behl et al., 1966). The plant contains perfume oils (Arctander, 1960) (5).
Page 52 of 75
A product containing one per cent Calendula officinalis extract was tested on 13
subjects. The test material, 0.2 mol, was applied to a site for 23 hours under occlusive patch daily for 20 days. The test sites were scored one hour after patch removal. The product was considered a "mild material".
18.1.4 Phototoxicity
The phototoxicity potential of a 50 per cent aqueous solution of a mixture containing Calendula officinalis extract, butylene glycol, and water was determined using
six guinea pigs (Ichimaru Pharcos Co. Ltd. 1994). One-tenth millilitre of the test
material was applied and exposed to light for 15 minutes, the mixture was not phototoxic.
18.1.5 Cases
No data available
18.1.6 Miscellaneous
The Council of Europe classifies Calendula officinalis as Recommended for use.
18.1.7 References
1.
2.
3.
4.
5.
Bruynzeel, D.P.; van Ketel, W.G.; Young, E.; van Joost, Th.; Smeenk, G. –
Contact sensitisation by alternative topical medicaments containing plant extracts – Contact Dermatitis 1992 Vol. 27, pp. 278
Cosmetic Ingredient Review Expert Panel, Monice Zondlo Fiume – Final Report on the Safety Assessment of Calendula Officinalis Extract and Calendula
Officinalis – International Journal of Toxicology 20 (suppl, 2); 13-20 2001
Council of Europe – Plant preparations used as ingredients of cosmetic products, 1. edition, 1994
Hörmann, H.P.; Korting, H.C. – Evidence for the Efficacy and Safety of Topical Herbal Drugs in Dermatology: Part I: Anti-inflammatory Agents – Phytomedicine Vol. 1/1994, pp. 161-171
Mitchell, John; Rook, Arthur – Botanical Dermatology – plant and plant products injurious to the skin – Vancouver Greenglass Ltd. 1979, pp.193
Page 53 of 75
19 Simmondsia chinensis
INCI names
Jojoba alcohol
Jojoba esters
Simmondsia chinensis cera
Simmondsia chinensis extract
Simmondsia chinensis oil
Simmondsia chinensis powder
CAS no.
61789-91-1
90045-98-0
61789-91-1
-
19.1.1 Other names
Jojoba, buxus chinensis
19.1.2 Allergy
A sensitization test of jojoba alcohol (10w-% in refined Simmondsia chinensis oil)
was carried out using 20 marmots. A group of 20 other marmots were used as untreated controls. Injections with the following liquids were made to the different
test sides on both sides of the animals: "Complete adjuvant"/water (mixing ratio
1:1), jojoba/alcohol solution, and "Complete adjuvant "/jojoba/alcohol solution
(mixing ratio 1:1). One week later, patches with 10 per cent jojoba/alcohol solutions were applied to the injection sites. Two weeks later, a patch was applied to
other sites than the injection sites. No sensitisation was observed (2).
The sensitization potential of a lip balm containing 20 per cent Simmondsia chinensis oil was determined on 208 women. 0.2 per cent of the test material was applied under a patch for 24 hours. Application was repeated three times a week over
a period of three weeks. The reactions were assessed prior to the next application
(after 24 and 48 hours). If a positive reaction was observed, the test site was
moved. If the new site showed a reaction as well, application was interrupted, and
the test person was patch tested after 10 to 19 days for 48 hours. Mild, non-specific
irritation was observed in one person. The product is not considered to be a sensitizer (2).
A product containing 0.5 per cent Simmondsia chinensis oil was tested on 152
healthy persons. The test material was applied under an occlusive patch on the upper part of their backs on Mondays, Wednesdays, and Fridays over a period of
three weeks. After a two-week non-treatment period, the patches with test material
were applied on new sites for 48 hours. The result was scored after 48 and 96
hours. None of the tested persons had any reactions, i.e. the product is not a sensitizer (2).
A group of six patients who are all suspected of being sensitive to Simmondsia
chinensis oil were patch tested with 20 per cent Simmondsia chinensis in olive oil,
20 per cent Simmondsia chinensis oil in liquid petrolatum, pure olive oil, and pure
mineral oil. Positive reactions to both Simmondsia chinensis oil mixtures were observed in five patients after 24 and 48 hours. None of the patients reacted to olive
oil or mineral oil. The last patient subsequently used pure Simmondsia chinensis
Page 54 of 75
oil as hair conditioner, which resulted in contact dermatitis of the scalp. A control
group of 48 persons was tested with pure Simmondsia chinensis oil; no reactions
were observed (2).
Scott and Scott (1982) report allergic contact dermatitis in six individuals (3).
19.1.3 Irritation
Jojobabutter-51TM is an isomorphic mixture of jojoba butter 21 (partly isomerized
Simmondsia chinensis oil) and hydrogenised Simmondsia chinensis cera. This
product was tested on six rabbits. 24 hours prior to application the mid-dorsal regions of the backs of the six rabbits were clipped free of hair. A dose of 0.5 ml of
the product was applied under a gauze patch to the abraded test sites and to the
non-abraded test sites. (1). After 24 hours the patches were removed and the test
sites wiped (but not washed). The results were observed and scored after 24 and 72
hours. The test was repeated on account of ambiguous results. The PII of the first
test was 0.5 placing jojoba butter 51 in the mild irritant category; the other test
gave a non-irritant result. As all irritation results obtained in the first test were observed after 24 hours of exposure, and whereas no irritation was observed after 72
hours, it is concluded that Simmondsia chinensis oil is not an irritant (1).
The skin-irritant potential of Simmondsia chinensis was determined in 10 guinea
pigs. Olive oil and liquid paraffin were used as controls. Over a period of 15 days,
Simmondsia chinensis oil (0.5 ml) was applied to the hairless skin of five of the
animals and to all animals of the control group. The remaining animals were tested
according to the same method after 30 days. The results were scored according to
the Draize technique (0 = no irritation, 4 strong erythema and incipient scab formation). No significant reactions to Simmondsia chinensis oil and olive oil were observed (2).
The irritation potential of a lip balm containing 20 per cent Simmondsia chinensis
was determined using six rabbits. 0.5 ml of test material was applied for 24 hours
under an occlusive patch on intact and abraded skin. The results were scored 24
and 72 hours after removal of patch. The irritation observed was minimal (2).
Two jojoba esters were tested using two groups of six rabbits each. The test material (0.5 ml) was applied to abraded and intact skin. Occlusive patches were applied
for 24 hours and subsequently removed. Excess test material was wiped off. The
results were scored after 24 and 72 hours. The irritation potentials were 0.42 and
1.08 respectively (2).
A Simmondsia chinensis cera was tested using six rabbits. The test material (0.5
ml) was applied to abraded and intact skin. Occlusive patches were applied for 24
hours and subsequently removed. Excess test material was wiped off. The results
were scored after 24 and 72 hours. The irritation potential was 0.17 (2).
The irritation potential of jojoba alcohol (10w-% in refined Simmondsia chinensis
oil) was tested using 20 marmots. The test material (0.5 ml) was applied under an
occlusive patch fixed with tape and rubber for 24 hours. The results were scored 24
and 48 hours after application. No reactions were observed (2).
Pure Simmondsia chinensis oil was tested on 26 patients who had previously had
dermatitis or eczema. Olive oil, thistle oil, and white petrolatum were used as controls. The test material was applied to sites on the upper part of the patients' backs
and retained with adhesive bandages. Reactions were assessed after 30 minutes and
Page 55 of 75
24 hours. Slight eczema was observed in one patient, but could not be observed 24
hours after removal of patch.
Pure Simmondsia chinensis oil was tested on 20 patients, who had previously had
dermatitis or eczema. Olive oil, thistle oil, and white petrolatum were used as controls. The test material was applied to sites on the upper part of the patients' backs
and retained with adhesive bandages. Reactions were assessed after 30 minutes and
24 hours. Slight eczema was observed in one patient after 30 minutes (2).
A clinical test of a lip balm containing 20 per cent Simmondsia chinensis was conducted. The test material was applied to 200 women daily over a period of four
days. The result was assessed immediately and after two and four weeks. No irritation reaction was observed (2).
The skin irritation potential of jojoba alcohol was tested on 60 persons. 20 persons
with healthy skin were patch tested with 10 per cent and 100 per cent jojoba alcohol, and 40 dermatitis patients were tested with 100 per cent jojoba alcohol. A 10
percent oleyl alcohol solution (health test persons) and a 100 per cent solution
(dermatitis patients) were used as control. The patches were applied to the upper
part of the persons' backs for 48 hours. Reactions were assessed 30 minutes and 24
hours after patch removal. In the group of healthy test persons one person reacted
to 10 per cent jojoba alcohol after 30 minutes, none after 24 hours. In the group of
dermatitis patients, one person reacted to 10 per cent jojoba alcohol after 30 minutes, none after 24 hours. The group of healthy persons showed no reaction to oleyl
alcohol. Jojoba alcohol is not a skin irritant (2).
19.1.4 Phototoxicity
The phototoxicity of a lip balm containing 20 per cent Simmondsia chinensis oil
was tested on 10 persons. 0.2 g of test material was applied to the inner side of the
test persons' forearms for 24 hours. The other arms were used as controls. After
patch removal, the test sites were irradiated for 15 minutes with UV light from a
distance of approximately 10 cm. The control sites were shielded during irradiation. None of the tested persons had any reactions. The product is not phototoxic
(2).
102 women took part in an outdoors test of phototoxicity. Each person was greased
with a sun lotion containing 0.5 per cent Simmondsia chinensis oil and stayed in
the sun for two hours over a period of two days. Three persons sensed a slight discomfort, which was not considered to be clinically significant (2).
The phototoxicity of jojoba alcohol was tested on 60 persons. 20 persons with
healthy skin were patch tested with 10 per cent and 100 per cent jojoba alcohol. 40
dermatitis patients were tested with 100 per cent jojoba alcohol. 10 per cent
(healthy skin) and 100 per cent (dermatitis patients) oleyl alcohol were used as
controls. The patches were applied to the upper part of the patients' backs for 48
hours. Each test site was irradiated with black light. A reaction was observed in one
patient. No reaction was observed in any of the persons with healthy skin. The control sites, which had only been treated with oleyl alcohol, showed no reactions. Jojoba alcohol is not phototoxic (2).
A lip balm containing 20 per cent Simmondsia chinensis oil was tested on 60 persons. 0.2 g of the test material was applied to the inner side of the persons' forearms for 24 hours. The other arms were used as controls. The material was applied
under an occlusive patch on Mondays, Wednesdays, and Thursdays – all in all nine
times. If no irritation was observed, the material was applied in the same site every
Page 56 of 75
time. After patch removal the site was irradiated with UV light for 15 minutes from
a distance of ten cm. The sites were scored immediately after patch removal and after the irradiation with UV light. A patch was applied to a new site after a nontreatment period of13 to 18 days; the site was then irradiated. No reactions were
observed. The product is not photosensitizing (2).
19.1.5 Cases
A 44-year-old woman had contracted dermatitis from a facial cream. She was patch
tested, first with the cream to which she reacted, and a year later with the individual components contained in the cream. She then reacted to 1.5 per cent Simmondsia chinensis oil and to 0.5 per cent myrisyl acetate mixed with meleated soybean
oil 1.5 per cent. One year later she was retested with the same components, but did
not react to Simmondsia chinensis oil, only to the myrisyl acetate mixed with soybean oil (4).
19.1.6 References
1.
Brown, James H., Jojoba Growers & Processors; Piccirillo, Vincent J.; Hartman, Villiam C., Borriston Laboratories - Jojobabutter-51TM - A primary
Dermal Irritation Study in Rabbits – Cosmetics & Toiletries Vol. 99 May
1984 pp. 57-58
2. Cosmetic Ingredient Review – Final Report on the safety Assessment of Jojoba Oil and Jojoba Wax – Journal of the American Collage of Toxicology
Vol. 11. Nr. 1, 1992
3. Lovell, Christopher R. – Plants and the Skin – Blackwell Scientific Publications 1993, pp. 207
Wantke, F.; Hemmer, W.; Götz, M.; Jarisch, R. – Contact dermatitis from jojoba
oil and myristyl lactate/maleated soybean oil – Contact Dermatitis 1996, 34 ,
pp.71-72
Page 57 of 75
20 Glycine soja
INCI names
Glycine soja extract
Glycine soja flour
Glycine soja germ extract
Glycine soja oil
Glycine soja unsaponifiables
Glycine soja protein
Glycine soja sprout extract
Glycine soja sterol
CAS no.
84776-91-0
68513-95-1
84776-91-0
8001-22-7
91770-69-1
9010-10-0
84776-91-0
-
20.1.1 Other names
Soybean, Glycine max, Glycine hispeda
20.1.2 Allergy
The oil has induced acne-like folliculitis in industrial workers (Greenberg & Lester
1954) (1).
Immunological and respiratory findings were studied in a group of 19 soybean
workers (age 21 to 48). A group of 31 transport workers was used as control. The
members of the control group were identical with the test group as concerns age,
sex and smoking habits. All soybean workers and 20 control subjects were tested in
standard tests (not described in detail) with aqueous extracts of soybeans and
common allergens. All soybean workers tested positive to soybean extract, as did
19 of the 20 controls. Only three of the 19 had increased soy specific IgE. The respiration of soybean workers was obviously lower than expected (3).
20.1.3 Irritation
No data available
20.1.4 Phototoxicity
No data available
20.1.5 Cases
A 55-year-old housewife reacted to facial cream – she first developed erythema
and, by the next day, swelling of the face. She was patch tested with the cream and
some standards and tested positive to the cream. Accordingly she was patch-tested
with the ingredients of the cream and tested positive only to the soybean extract.
She had previously been eating soybeans without having any reaction, and an allergen specific IgE test was negative (Pharmacia CAP method; fluorometric assay)
(2).
Page 58 of 75
20.1.6 References
1. Mitchell, John; Rook, Arthur – Botanical Dermatology – plant and plant products injurious to the skin – Vancouver Greenglass Ltd. 1979, pp.403-404
2. Shaffrali, Freida C.G.; Gawkrodger, David J. – Contact dermatitis from soybean extract in cosmetic cream – Contact Dermatitis 2001, 44, 51-52
3. Zuskin, E; Kanceljak, B; Schachter, E.N.; Witek, T.J. Jr.; Marom, Z.;
Gos’Maayani S. – Immunological and Respiratory changes in soy bean workers – Int. Arch Occup Environ Health 1991; 63(1); 15-20
Page 59 of 75
21 Citrus
INCI names
Citrus aurentium bergamia extract
Citrus aurentium bergamia oil
CAS no.
89957-91-5
8007-75-8/899
Citrus nobilis oil
Citrus nobilis fruit extract
Citrus nobilis extract
8008-31-9
84929-38-4
84929-38-4
Citrus medica limonum extract
Citrus medica limonum juice
Citrus medica limonum juice extract
Citrus medica limonum juice powder
Citrus medica limonum oil
Citrus medica limonum peel extract
84929-31-7
84929-31-7
84929-31-7
84929-31-7
8008-56-8
84929-31-7
Citrus aurentium dulcis extract
Citrus aurentium dulcis flower extract
Citrus aurentium dulcis flower oil
Citrus aurentium dulcis flower water
Citrus aurentium dulcis oil
Citrus aurentium dulcis peel cera
Citrus aurentium dulcis peel extract
Citrus aurentium dulcis seed extract
Citrus aurentium dulcis water
8028-48-6
8028-48-6
8028-48-6
8028-48-6
8008-57-9
8028-48-6
8028-48-6
8028-48-6
8028-48-6
Citrus fruits are dealt with under one chapter due to their common features, and because they are often dealt with in literature.
21.1.1 Other names
Citrus aurentium bergamia: Bergamot, Citrus aurentius var. bergamia.
Citrus nobilis: Mandarin
Citrus medica limonum: Citron, lemon. citrus limonium
Citrus aurentium dulcis: Orange
21.1.2 Allergy
The outer layer of citrus fruits contains 90 per cent d-limonene, whereas the contents in the last 10 per cent vary from species to species. D-limonene is considered
to be the main reason for sensitization from citrus fruits, but a minor allergen may
be the α-terpene – at least for lemon (Puglisi, 1951) or carotene (Hjorth, 1936; Sulzberger, 1936). D-limonene is an irritant as well as an allergenic substance. Contact
hypersensitivity to the oil is common, but 8 of Janson's 29 cases (1953) were sensitivity to the juice, 19 to the oil and one to the blossoms and the tree, respectively.
Most people were sensitive to either lemon or orange, not to both. Sensitization to
Citrus in general is seen, too. The symptoms most frequently occur on hands and in
the face as erythema, swelling, irritation, and blisters.
Page 60 of 75
D-limonene is produced from either citrus oils or juice. Human toxicity: Sensitizing, skin-irritant (3).
In the overview of hazardous substances, d-limonene is identified by R34, i.e. it
may induce sensitivity from contact with the skin (4).
Fruit can workers get inflammation under and around their nails and may lose the
nails (Kingery & Thienes, 1925). Ten per cent of all cases of dermatitis on the eye
lids were ascribed to contact sensitization to fruit peel (Hazen, 1944). Ten per cent
of local allergy on the upper skin of the hands is ascribed to penetration of the active substances in fruit (Rowe, 1946). Maibach and Johnson discussed contact nettle rash in 1975. Sensitization to d-limonene is ascribed to auto oxidation products
(Opdyke, 1974) (7).
The peel of bergamot (Citrus aurentium bergamia) and other citrus oils like orange
(Citrus dulcis), lemon (Citrus medica limonum), mandarin (Citrus nobilis), and
grape contain 95 per cent d-limonene. The industry uses it in concentrations up to
95 per cent for degreasing purposes. Experiments indicate no sensitization; while
other experiments show powerful sensitization, depending on the used test method.
The investigation attempts to simulate industrial handling of d-limonene and the
consequences when d-limonene is exposed to the air. Patch tests were performed
with guinea pigs. A non-irritant level was determined initially by injecting
"Freund's Complete Adjuvant" in four animals and testing them one week later
with d-limonene 0.1; 0.5; 1 and 5 per cent in olive oil. No reaction was observed,
and the test concentrations were increased to 0.5, 1, and 5 per cent in olive oil. In
another test the hair was clipped of the animal flanks. "Ventilated" d-limonene (exposed to air for two months, stirred four times a day) in olive oil was applied under
a patch for 24 hours, and the reactions were observed 48 and 72 hours after start of
exposure. Sensitized animals had red, swollen skin at the test sites. Thus, it is not
the d-limonene it self, but the limonene oxide, that is the sensitizer (8).
Limonene easily oxides into a mixture of oxygenated, monocyclic terpenes, which
are powerful contact allergens (9).
Allergic contact dermatitis is rare, but often seen in fruit dealers and bartenders.
The potential sensitising substances are geraniol, citral, and a hydro-peroxide derivate of d-limonene. The limonene itself is not considered to be a sensitizer (10).
Orange oil is derived from the peel of Citrus sinensis and Citrus aurentium var dulcis and contains 90 per cent d-limonene. Human toxicity: Patch tests with eight per
cent in petrolatum had no irritant reaction after 48 hours, no sensitization, and no
phototoxic effects (12).
21.1.3 Irritation
All citrus juices are irritants, lemon juice being the strongest irritant due to its high
content of citric acid and its pH value being the highest (1).
D-limonene is an irritant (1).
In the overview of hazardous substances, d-limonene is identified by R34, i.e. it is
skin irritant (4).
Page 61 of 75
21.1.4 Phototoxicity
Citrus aurentium bergamia induces fytofotodermatitis. A subspecies is Berlocque
dermatitis from sun bathing after application of eau de cologne or perfume containing bergamot oil. Initial erythema may be so weak that it is not noted, or it may be
strong enough to make the skin suppurate. Erythema is followed by clear and nasty
skin pigmentation that persists for several months. The frequency has decreased,
partly because of the lower content of bergamot oil in perfumes, partly because of
the use of synthetic oil and oil without furocoumarin (Marzulli and Maibach,
1970). Bergaptene – 5-methoxypsoralene – intensifies the reaction of the skin to
UV radiation and causes pigmentation (Harber et al. 1964 and Burdick 1966) (1).
5-methoxypsoralen is found in natural bergamot oil (Citrus aurentium bergamia
oil) in concentrations of three to 36 mg/g. Moreover, it is found in Citrus aurentifolia (lime), Citrus paradisi (grape), and Citrus aurentium (sour orange). Human toxicity: Photosensitizing, chromosome damage to human cells, hyper pigmentation
(2).
Until a few years ago bergamot oil (Citrus aurentium bergamia oil) was frequently
used in cosmetics. However, it is now prohibited in most courtiers due to side effects. Bergamot oil is a photosensitizer because of its content of 5methoxypsoralene (5-MOP). However, 5-MOP is also photomutagenic (7).
Citrus fruit, especially lemon and bergamot, are major causes of phototoxic reactions (10).
The active component in bergamot oil from Citrus aurentium bergamia was first
found in the 1830s and name bergapten. It was characterised as a 5methoxypsoralene and identified as the main reason for the photo-toxicity of the
extract of bergamot peel. The name Brelocque dermatitis originates from the German word berlock (French Breloque), meaning jewellery or amulet. The name was
found by Rosenthal in 1925 in order to describe pendant-like stripes of pigmentation on neck, face, arms, and body. Although he expected them to be the result of
drops of liquids, he was not aware that Freund had described pigmented spots due
to eau de cologne that had been exposed to the sun of in 1916. The
phototoxic ingredient turned out to be oil of bergamot. In the 1950s and 1960s several cases were seen because of the increased use of perfumes containing bergamot
oil and increasing sunbathing. Gradually such cases became more rare as natural
bergamot oils were replaced by synthetic bergamot oils (10).
Lemon oil is produced from the fresh peel of Citrus limonium. Human toxicity: A
patch test of ten per cent oil in petrolatum revealed no irritation after 48 hours. Distilled oil at ten per cent in petrolatum caused no irritation after 48 hours patch test.
HSDB gives examples of tests showing clear phototoxic effect, low-level phototoxic effects and absence of phototoxic effects (11).
21.1.5 Cases
No data available
21.1.6 Miscellaneous
5-methoxypsoralen is not allowed in cosmetic products (5).
Page 62 of 75
21.1.7 References
1. Cronin, Etain – Contact Dermatitis – Churchill Livingstone 1980, pp.532-534,
pp.419-421
2. HSDB – 5-Methoxypsoralen. CAS no. 484-20-8
3. HSDB – D-limonene – CAS no. 5989-27-5
4. Bekendtgørelse om listen over farlige stoffer, no. 733, 31 July 2000
5. Bekendtgørelse om kosmetiske produkter, no. 594, 6 June 2000
6. Mitchell, John; Rook, Arthur – Botanical Dermatology – plant and plant products injurious to the skin – Vancouver Greenglass Ltd. 1979, pp.608-609
7. Kaddu, S.; Kerl, H.; Wolf, P. – Accidental bollous phototoxic reactions to bergamot aromatherapy oil – J. Am. Acad. Dermatol. 2001, Sept.; 45(3); 458-461
– abstract
8. Karlberg, A.T.; Boman, A.; Melin, B. – Animal experiments in the allergenicity of d-limonene - The citrus solvent – Ann. occup. Hyg., Vol. 35, No.4, pp.
419-426, 1991
9. Karlberg, A.T.; Doom-Goossens A. – Contact allergy to oxidized d-limonene
among dermatitis patients – Contact Dermatitis 1997 Apr.; 36(4); 201-206 –
abstract
10. Lovell, Christopher R. – Plants and the skin – Blackwell Scientific Publications 1993, pp.133, pp.69, pp.83
11. HSDB - Lemon oil – CAS no. 8008-56-8
12. HSDB- Oil of orange – CAS no. 8008-57-9
Page 63 of 75
22 Daucus carota
INCI names
Daucus carota
Daucus carota extract
Daucus carota juice
Daucus carota oil
Daucus carota seed extract
CAS no.
84929-61-3
84929-61-3
8015-88-1
84929-61-3
22.1.1 Other names
Daucus oil
22.1.2 Allergy
Five of 1,000 patients treated in clinic had occupational allergic contact dermatitis
from spices. The patients were also patch-tested positive to carrots, tomatoes, and
lettuce (3).
26 patients (aged 18 to 59) with histories of allergic reactions to carrots underwent
skin prick tests with carrot extract (Stallergènes), fresh carrot, and various pollen
extracts. Reactions were assessed after 15 minutes. Only five patents tested positive to the carrot extract, whereas all patients tested positive to raw carrot (4).
Dermatitis from carrots is most frequently seen in industrial workers who are canning carrots (Klauder & Kimmich, 1956). It is also seen in greengrocers (Sinha et
al., 1977). Allergic reactions are found in two housewives. Methanol and ethanol
extracts gave positive reactions (Foulds & Sadhra, 1990). Daucus carota contains
falcarinole, an allergen that is also found in ivy (Hausen et al, 1986) (6).
Carrots may induce contact urticaria (7).
Acute and chronic dermatitis on hands, forearms, and in some persons also on
the neck and in the face. 115 of 17 persons tested positive to patch tests with raw
carrot. Aqueous extracts, ether, and acetone extracts, carrot juice and heated
carrot gave positive reactions in patch tests (Peck et al., 1944) (8).
22.1.3 Irritation
Skin, rabbit, 500 mg, 24 hours: Slight effect
Skin, guinea pig, 100% carrot oil: Slight effect (9)
Carrot is an irritant, and contact with raw carrot, dried carrot, carrot juice, and to a
certain degree heated carrot may induce irritant reactions (7).
22.1.4 Phototoxicity
Tests with alcohol extracts and alcohol/water extracts of carrot showed that the extract caused slight photosensitization effects (5).
Page 64 of 75
Daucus carota has shown phototoxic activity resulting in exanthem (Klauder &
Kimmich, 1956) (6).
Daucus carota has shown phototoxic activity (7).
22.1.5 Cases
A 38-year-old man presented with carrot dermatitis developed after peeling and
grating carrots in his kitchen at home. The dermatitis showed as e.g. facial swellings. He was patch-tested positive to carrot, celery, and ivy. Besides, he had a 30year history of recurrent dermatitis on his hands. He could eat cooked carrots, but
reacted to raw carrot. Allergic contact dermatitis to carrots is mostly occupational.
(2).
22.1.6 Miscellaneous
Daucus carota is classified as Recommended for use by the Council of Europe (1).
22.1.7 Remarks
Source 5 - awaiting publication
22.1.8 References
1. Council of Europe – Plant preparations used as ingredients of cosmetic products, 1. edition, 1994
2. S. R. Murdoch and J. Dempster – Allergic contact dermatitis – Contact Dermatitis 2000: 42(4): 236
3. Kanerva, L.; Estlander, T.; Jolanki R. – Occupational allergic contact dermatitis from spices – Contact Dermatitis 1996: 35(3): 157-6
4. Ballmer-Weber, Barbara K., MD; Wüthrich, Brunello, MD; Wangorsch, Andrea, BSc; Fötisch, Kay, PhD; Altmann, Friedrich, PhD; and Vieths, Stefan,
PhD – Carrot allergy: Double-blinded, placebo-controlled food challenge and
identification of allergens – Journal of Allergy Clin. Immunol. 2001, Aug:
108(2): 301-307
5. VanDijk, E.; Berrens, L. – Plants as an etiological factor in phytophotodermatitis – Dermatologica 1964, 129(4), 321-328 - Abstract
6. Lovell, Christopher R. – Plants and the skin – Blackwell Scientific Publications
1993, pp. 87,143
7. CRONIN, ETAIN – CONTACT DERMATITIS – CHURCHILL LIVINGSTONE 1980, PP. 536
8. Mitchell, John; Rook, Arthur – Botanical Dermatology – plant and plant products injurious to the skin – Vancouver Greenglass Ltd. 1979, pp.689. RTECS:
Food and Cosmetics Toxicology 1976, 14, 705
Page 65 of 75
23 Bisabolol
INCI names
Bisabolol
CAS no.
515-69-5
23.1.1 Other names
6-Methyl-2-(4-methyl-3-cyclohexen-1-yl)-5-hepten-2-ol, alpha-bisabolol.
Bisabolol is extracted from various plants, e.g. camomile.
23.1.2 Allergy
25 subjects underwent a sensitization test according to the “Kligman maximization
protocol”. The test material was a commercial-grade solution containing 0.1 per
cent Bisabolol. A patch with sodium lauryl sulphate was applied for 24 hours (and
then removed) prior to application of 0.1 g of the test material for 48 hours. The
test was repeated five times. No positive reactions were observed in the test persons at any time (Ivey Laboratories, 1992) (1).
23.1.3 Irritation
Semi occlusive patches containing undiluted Bisabolol were applied for four hours
contact to three rabbits. Slight erythema was noted in all rabbits at the 4-hour reading. By 24 hours, the reaction increased to well-defined erythema in two rabbits,
one of which also developed slight oedema. By 48 hours, the erythema was no
longer observed in rabbit no. 1, had decreased to very slight in rabbit no. 2, and
remained well-defined in rabbit no. 3. By 72 hours, very slight erythema was noted
only in rabbit no. 3. However, scaling was noted in rabbits nos. 2 and 3. After 7
days scaling was noted in all three rabbits (BASF, 1989a) (1).
No irritant effects were observed in 20 persons who were patch-tested with five per
cent Bisabolol in petrolatum. The persons suffered or were suspected of suffering
from allergy to cosmetic products (de Groot, 1994) (1).
23.1.4 Phototoxicity
In a photosensitization assay, Bisabolol (three and 15 per cent) was applied to the
neck skin of five guinea pigs. The test material was dissolved in absolute alcohol.
The guinea pigs were subsequently irradiated with light for 15 minutes. A group,
which was treated with 15 per cent v/v Bisabolol but not irradiated, was maintained
to monitor the effect of the high dose. A control group was treated with alcohol followed by irradiation, and a positive control group was treated with tetrachlorosalicylanilide followed by irradiation. The protocol was followed for five days. Following a nine-day non-treatment period the protocol was repeated on 2 successive
days. In this phase, the protocol was modified in that the test material and the positive control material were now dissolved in olive oil and the vehicle control was
olive oil. The assay was repeated after a 12-day non-treatment period. The test material and the controls were dissolved in a commercial soap, and the soap was applied to the control group. No photosensitization was observed (BASF, 1981) (1).
Page 66 of 75
23.1.5 Cases
A 37-year-old woman gave a two-week history of three episodes of facial swelling.
At the time of consultation, her skin was normal. She was patch-tested to some
standards together with her own cosmetics. A positive reaction to a cosmetic containing 12.5 per cent plant extracts was obtained. Testing the individual ingredients
produced a positive reaction only to Bisabolol (one per cent pet: purity 87 to 93 per
cent). The impurities in the sample of Bisabolol were: bisabolene, bisabololoxide,
farnesol, nerolid, and chamazulene. Patch tests in 30 controls were negative. The
publication mentions that Matricaria recutita may contain as much as 50 per cent
Bisabolol (2).
23.1.6 Miscellaneous
Bisabolol is used in various cosmetics at concentrations of 0,001 to 1 per cent (1).
23.1.7 References
1. Madhaven, Bindu Nair – Final report on the safety assessment of Bisabolol –
International Journal of Toxicology, 1999: 18(3): 33-40
2. Wilkinson, S.M.; Hausen, B.M. and Beck, M.H. – Allergic contact dermatitis
from plant extracts in a cosmetic – Contact Dermatitis 1995, 33, 58
Page 67 of 75
24 Aesculus hippocastanum
INCI names
Aesculus hippocastanum bark extract
Aesculus hippocastanum
CAS no.
8053-39-2
8053-93-2
24.1.1 Other names
Horse chestnut
24.1.2 Allergy
No data available
24.1.3 Irritation
No data available
24.1.4 Phototoxicity
No data available
24.1.5 Cases
A 51-year-old man was prick-tested positive to aescin. Aescin is derived from the
plant Aesculus hippocastanum. It was concluded that the man suffered from contact urticaria due to aescin; the mechanism, however, is not known (3).
A patient had acute dermatitis from the extract of Aesculus hippocastanum. The
patient was both eating pills and applying the material to his skin (R. J. Jackson,
1977) (4).
An extract of Aesculus hippocastanum caused pruritus. A patch test showed that
the reason was the component esculin (2).
24.1.6 Miscellaneous
Aesculus hippocastanum is classified as Recommended for use by the Council of
Europe (1).
24.1.7 Remarks
Source 2 – awaiting publication
24.1.8 References
1. Council of Europe – Plant preparations used as ingredients of cosmetic products, 1. edition, 1994
Page 68 of 75
2. Comaish, J.S.; Kersey, P.J.; – Contact dermatitis to extract of horse chestnut
(Esculin) – Contact Dermatitis, 1980, 6, 150-151 – Abstract. Also described by
C.R. Lovell – Plants and the skin, 1993. Escribano
3. M.M.; Munõz-Bellido, F.J.; Velázquez, J.; Delgado, J.; Serrano, P.; Guardia,
J.; Condé, J. – Contact urticaria due to aescin – Contact Dermatitis 1997, 37,
233
4. Mitchell, John; Rook, Arthur – Botanical Dermatology – plant and plant products injurious to the skin – Vancouver Greenglass Ltd. 1979, pp.745
Page 69 of 75
25 Ananas sativus
INCI names
Ananas sativus extract
CAS no.
68917-26-0
25.1.1 Other names
Ananas comosus, pineapple
25.1.2 Allergy
Pineapple flesh may induce contact urticaria. Bromelain contained in pineapple
may induce occupational dermatitis on the hands (Polunin, 1951) (2).
25.1.3 Irritation
Pineapple contains know skin irritants: Bromelain, raphides, and acid - mostly
lemon acid. Bromelain from juice may result in considerable damage. The damage
is not allergic but probably physical/chemical. Workers in the pineapple juice industry may develop hurting surfaces on their hands and wrinkled skin after a few
days of work. By the end of the harvest season (when the exposure comes to an
end), the skin returns to its normal state (3).
25.1.4 Phototoxicity
No data available
25.1.5 Cases
A 58-year-old woman developed occupational asthma and rhinitis from her work
with bromelain, a protease of pineapple. In a prick test she was tested positive to
bromelain. Testing with respiration and ingestion of bromelain also induced asthmatic reactions (1).
25.1.6 Remarks
Source 1 – awaiting publication
25.1.7 References
1. Baur, X.; Fruhmann, G.; – Allergic reactions, including asthma, to the pineapple protease bromelain following occupational exposure – Clin. Allergy, 1979:
Sep,9(5): 443-50 – Abstract
2. Lovell, Christopher R. – Plants and the skin – Blackwell Scientific Publications
1993, pp.36, 53
Cronin, Etain – Contact Dermatitis – Churchill Livingstone 1980, pp.490
Page 70 of 75
26 Persea grattissima
INCI names
Persea grattissima cera
Persea grattissima extract
Persea grattissima leaf extract
Persea grattissima oil
Persea grattissima oil unsaponifiables
Persea grattissima powder
CAS no.
227200-57-9
84695-98-7
84695-98-7
8024-32-6
91770-40-0
-
26.1.1 Other names
Avocado oil
26.1.2
Allergy
17 patients with allergy to avocado (ingestion) were prick-tested with fresh avocado. A group of ten healthy persons and ten persons with dust mites allergy were
used as control. The tested persons were between 18 and 54 years of age and from
very different types of occupation. All 17 persons tested positive to “strong avocado” (green with smooth peel), and 14 tested positive to “Hass avocado” (dark
with wrinkled peel). No positive effects were observed in the control group (1).
Avocado oil applied to human skin did not induce any irritation, but two cases of
potential sensitization were reported (2).
100 randomly selected persons with allergic dermatitis were prick-tested with avocado. Prior to the test, the patients had been examined for avocado allergy. 21 had
tested positive to avocado in a prick test. Eight of these 21 also had symptoms following ingestion. Based on this investigation it may be concluded that allergic reactions of the skin to avocado are common (approximately 20 per cent) in people
with contact allergy. Avocado sensitive patients are often allergic to other foodstuffs and latex (3).
A hand cream containing four per cent avocado oil was tested on 51 subjects. The
Draize test revealed no sensitizing effect (Hill Top Research, 1976) (4).
100 females were subjected to patch tests using 100 per cent avocado oil. Patches
were removed after 48 hours and the application sites observed immediately for
skin reaction. Subjects were re-examined after 24 hours. The test was repeated 14
days later. An identical test was conducted with
different skin care products containing between 0.5 to 5.0 per cent avocado oil.
There was no evidence of sensitization in any of the tests (CTFA, 1978) (4).
Lipstick containing 10 per cent avocado oil was tested on 92 females and 18 males.
There was no evidence of sensitization (CTFA, 1978) (4).
A lipstick containing 9.8 per cent avocado oil and a lipstick containing 10.2 per
cent avocado oil was applied in a patch test to the back of 86 and 90 females, respectively and 7 and 13 males, respectively for a period of 72 hours followed by an
Page 71 of 75
eight alternate 24-hour test periods. No evidence of sensitization was observed.
The same test was conducted on 47 women and five men, using a lipstick containing five per cent avocado oil. This test did not give any evidence of sensitization either (CTFA, 1978) (4).
26.1.3 Irritation
Application of avocado oil to human skin does not induce irritation. Skin irritation
and slight effect on eyelids was found in rats treated with avocado oil (2).
The skin irritation potential of several shampoo products containing avocado oil
was tested by skin application. The tests involved a 24-hour exposure period followed by observation of an additional two to six days. Signs of irritation were
scored according to Draize. One undiluted formulation and another diluted 1:10
gave scores of 6.0 and 5.2, respectively, of a maximum possible score of 8.0. These
and another formulation when diluted 1:20 or 1:40 had scores of 1.6 to 2.6. These
shampoos in undiluted form are quite irritating. According to the author, this effect
is probably due to an ingredient, or ingredients, other than the 0.5 per cent concentration of avocado oil (CTFA, 1978) (4), but which one(s) is not stated.
A night cream containing 1.5 per cent avocado oil applied undiluted under patches
to the lateral aspect of the upper arm of 25 subjects (age, race, and sex not given)
for 18 hours. Four daily applications were made; readings at 24 hours after each
patch was applied showed six subjects with slight erythema after the second application, 11 with slight to severe erythema following the third application, and 11
with slight to moderate after the fourth application. All readings after the first patch
application were negative (CTFA, 1978) (4).
A shampoo containing 0.05 per cent avocado oil diluted 1: 100 in water was applied to the surface of the arm of 50 human subjects (males and females, race not
stated) for eight 12-hour periods. Following a two-week rest a patch was applied
for 24 hours. Results during the induction tests showed 19 responses of slight erythema and one with severe erythema. The greatest effect was noted on the eighth
day when four subjects had slight erythema and one had severe erythema. At 24
hours after removal, one subject had slight erythema and three had slight erythema.
At 24 and 48 hours after removal, one subject had slight erythema (CTFA, 1978)
(4).
Four per cent avocado oil in hand cream was tested on 51 human subjects. In the
Draize test the hand cream was found to be non-irritant.
One hundred females were subjected to patch tests using 100 per cent avocado oil.
Patches were removed after 48 hours, and the application sites were observed immediately and following 24 hours for skin reaction. The test was repeated 14 days
later. Identical tests were conducted with different skin care products containing
0.5 to 5.0 per cent avocado oil. The scores gave no evidence of irritation (CTFA,
1978) (4).
Lipstick containing 9.6 per cent avocado oil was applied under a patch to the backs
of 57 females and one male for 72 hours. There was little or no irritation effect observed (CTFA, 1978) (4).
Lipstick containing 10 per cent avocado oil was tested on 92 females and 18 males.
There was little or no irritation potential observed (CTFA, 1978) (4).
Page 72 of 75
Lipstick containing 9.8 per cent avocado oil and lipstick containing 10.2 per cent
avocado oil were applied under patches to the back of 86 and 90 females and seven
and 13 males for one 72-hour period, followed by eight alternate 24-hour periods.
After a rest of 13 days, challenge patches were applied for 48 hours. There was little or no irritation potential. Identical test with lipstick containing five per cent
avocado oil was conducted on 47 females and five males. This test as well showed
little or no irritation potential (CTFA, 1978) (4).
Skin, rabbit, 500 mg, 24 hours: strongly irritating (5)
26.1.4 Phototoxicity
No data available
26.1.5 Cases
No data available
26.1.6 Remarks
Source 2 – awaiting publication
The authors do not support the conclusion in source 4 that the skin irritation effect
is due to one, or more ingredients, other than avocado oil.
The majority of tests referred to in source 4 were conducted under the CTFA
(Cosmetic, Toiletry and Fragrance Association).
Source 5 refers to the same source as mentioned under the second reference “Irritation”. It says here that the effect is probably due to one, or several ingredients,
other than avocado oil (see also above).
26.1.7 References
1. Bianco, C; Carrillo, T.; Castillo, R.; Quiralte, J.; Cuevas, M. – Avocado hypersensitivity – Allergy 1994, 49, pp.454-459
2. BIBRA working group – Avocado Oil - Toxicity profile. BIBRA Toxicology
International, 1990, 3 p. - Abstract
3. Telez-Dias, Gloria; Ellis, Mark H.; Morales-Russo, Fatima; Heiner, Douglas
C. – Prevalence of Avocado Allergy among Atopic Patients – Allergy Proc.
1995 Sep.-Oct.; 16(5), pp. 241-243
4. Anonymous – Final report on the safety assessment for Avocado Oil – Journal of Environmental Pathology and Toxicology, 1980: 4(4): 93-103
5. RTECS: Journal of Environmental Pathology and Toxicology 1980, 4(4), 93103
Page 73 of 75
27 Triticum vulgare
INCI names
Triticum vulgare bran
Triticum vulgare bran extract
Triticum vulgare extract
Triticum vulgare flour
Triticum vulgare germ
Triticum vulgare germ extract
Triticum vulgare germ oil
Triticum vulgare germ oil unsaponifiables
Triticum vulgare germ protein
Triticum vulgare gluten
Triticum vulgare powder
Triticum vulgare protein
Triticum vulgare sprout extract
Triticum vulgare starch
CAS no.
84012-44-2
84012-44-2
130498-22-5
84012-44-2
68917-73-7
93384-22-6
84012-44-2
9005-25-8
27.1.1 Other names
Wheat germ oil
27.1.2 Allergy
α-tocopherol (large amounts contained in wheat germ oil) is noted as a contact allergen (1).
Allergic contact dermatitis is rare in the grass family. However, wheat seems to
have induced allergic reactions that may be hard to distinguish from irritant reactions (Pigatto et al., 1987) (4).
Wheat may induce contact urticaria (5).
Two petrolatum-based hairdressings containing wheat germ oil (1 and 1.5 per cent)
were tested for contact sensitization using a patch test procedure on 53 male and
female subjects. The products were found to be non-sensitizing. One subject was
sensitized to a component of the one per cent sample, but the sensitizer was not
identified. A similar procedure was used to test an oil and water emulsion hand
cream containing one per cent wheat germ oil on 51 male and female subjects. The
product was found to be non-sensitizing (Hill Top Research, 1976a, b) (3).
27.1.3 Irritation
100 per cent wheat germ oil and two per cent wheat germ oil in a water emulsion
scored 0.15 and 0 in a Draize test on intact and abraded skin of rabbits (CTFA,
1978d). Similar tests with shampoos, hair spray, conditioner, and hand and body
Page 74 of 75
lotions containing wheat germ oil gave mild irritation with scores between 0 and
5.75 (CTFA, 1977) (3).
48-hour patch tests on 100 persons did not give any positive reactions to one, ten,
and 50 per cent wheat germ oil in mineral oil. Draize or maximization methods
were not used (CTFA, 1978g) (3).
Two petrolatum-based hairdressings containing wheat germ oil (1 and 1.5 per cent)
were tested for contact sensitization using a patch test procedure on 53 male and
female subjects. The products were found to be non-irritant. A similar procedure
was used to test an oil and water emulsion hand cream containing one per cent
wheat germ oil on 51 male and female subjects. The product was found to be nonirritant (Hill Top Research, 1976a, b) (3).
Skin, rabbit, 500 mg: slight effect
Eyes, rabbit, 100 mg: slight effect (2)
27.1.4 Phototoxicity
No data available
27.1.5 Cases
No data available
27.1.6 Miscellaneous
Wheat germ oil is used as an ingredient in cosmetics at concentrations of 0.1 to 50
per cent. The main purpose of wheat germ oil is to act as an antioxidant (vitamin E
– alfa-tocopherol) (3).
27.1.7 Remarks
Source 2 refers to source 3.
A major part of the tests referred to in source 3 were conducted under the CTFA
(Cosmetic, Toiletry and Fragrance Association). Moreover it is noted that one test
mentions slight irritation at scores from 0 to 5.75. Scores of more that five are not
usually referred to as slight, but as moderately irritant.
27.1.8 References
1. AMI-rapport No. 33/1990 – Allergi- og overfølsomhedsfremkaldende stoffer i
arbejdsmiljøet, p. 68
2. RTECS: Journal of Environmental Pathology and Toxicology 1980, 4(4), 33
3. Anonymous – Final report on the safety assessment for Wheat Germ Oil –
Journal of Environmental Pathology and Toxicology, 1980: 4(4): 33-45
4. Lovell, Christopher R. – Plants and the skin – Blackwell Scientific Publications 1993, pp.229-232
5. Cronin, Etain – Contact Dermatitis – Churchill Livingstone 1980, pp. 25
Page 75 of 75