Mixture classification exercises
Seminar for Baltic States
Outi Tunnela
ECHA Helpdesk
Examples:
How are cut-off values used?
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Cut-off values
Ingredient
w
%
LD50(mg/
kg)
Classification
Anionic
surfactant
9.2
>5000
Not classified
Thickening
agent
0.8
3600
Skin Irrit. 2
Water
90
Not classified
Example 1: Below cut-off value
1%.
The mixture is not classified as
Skin Irrit. 2.
Ingredient
w%
LD50(mg/
kg)
Classification
Anionic
surfactant
8.2
>5000
Not classified
Example 2: Above cut-off value
1%.
Thickening
agent
1.8
Skin Irrit. 2
The mixture might be classified.
Water
90
Not classified
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Generic concentration limits for skin corrosion/irritation
Additivity approach applies
Generic concentration limits of ingredients classified that trigger classification of
the mixture (Table 3.2.3 of Annex I)
Sum of ingredients
classified as:
Skin Corrosive
Categories 1A, 1B, 1C
Concentration triggering classification
of a mixture as:
Skin Corrosive
Skin Irritant
Category 1
Category 2
≥5%
Skin irritant Category 2
(10* x Skin Corrosive
Category 1A, 1B, 1C) +
Skin irritant Category 2
* Weighting factor of 10 if Category 1 component
≥ 1 % but < 5 %
≥ 10 %
≥ 10 %
≥ 1% but ≤ 5% in a mixture
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Generic concentration limits for reproduction toxicity/effects on or via
lactation
Additivity approach does not apply
Generic concentration limits of classified ingredients that trigger classification of
the mixture (Table 3.7.2 of Annex I)
Ingredient
classified as:
Repro cat. 1A
Repro cat. 1B
Repro cat. 2
Concentration triggering classification of a mixture as:
Repr. tox cat. 1A
Repr. tox cat.
1B
Repr.tox cat.2
Effects on or via
lactation
≥ 0,3 %
≥ 0,3 %
≥ 3,0 %
Effects on or via
lactation
≥ 0,3 %
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Example:
Methods for mixture classification
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Acute toxicity, when
Data available for all ingredients:
• In order to ensure that classification of the mixture is accurate and
that the calculation need only be performed once, the acute
toxicity estimate (ATE) of ingredients shall be considered:
• Include ingredients with a known acute toxicity, which fall into any of the
acute toxicity categories shown in Table 3.1.1
• Ignore ingredients that are presumed not acutely toxic (e.g., water,
sugar)
• Ignore ingredients, if the oral limit test does not show acute toxicity at 2
000 mg/kg bodyweight.
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Calculation Method - Additivity formula
Acute Toxicity
Total concentration of the
ingredient(s) with unknown
toxicity is <= 10 %;
Total concentration of the
ingredient(s) with unknown
toxicity is >10 %;
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Conversion values
Where an ATE is not available for an ingredient of a mixture, but available information
can provide a value derived from the conversion table, this conversion value may be used
for calculation.
Conversion from experimentally obtained acute toxicity range values (or acute toxicity
hazard categories) to acute toxicity point estimates for classification of the respective routes
of exposure
Table 3.1.2
Exposure route
Oral
(mg/kg bw)
Classification category or
experimentally obtained acute
toxicity range estimate
0 < category 1 ≤ 5
5 < category 2 ≤ 50
50 < category 3 ≤ 300
300 < category 4 ≤ 2000
Converted acute
toxicity point
estimate
0,5
5
100
500
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EXAMPLE:
How mixture A is classified?
MIXTURE A
Concentration
LD50 oral
Substance 1
1%
225 mg/kg
Substance 2
3%
100 mg/kg
Substance 3
10%
Water
76%
Classification
Acute tox.
category 3, oral
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1.
Step: conversion from hazard category to point estimate:
Table 3.1.2 (Annex 1)
Exposure route
Oral
(mg/kg bw)
Classification category or
experimentally obtained acute
toxicity range estimate
0 < category 1 ≤ 5
5 < category 2 ≤ 50
50 < category 3 ≤ 300
300 < category 4 ≤ 2000
Converted acute
toxicity point
estimate
0,5
5
100
500
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2. Step: calculation of ATEmixture
Concentration
LD50 oral
Substance 1
1%
225 mg/kg
Substance 2
3%
100 mg/kg
Substance 3
10%
Water
76%
Acute tox, cat 3
100
ATEmixture
ATEmixture
=
225
+
100
ATE: 100
Ci
=∑ ATE
n
3
1
100
Classification
i
10
+
100
ATEmixture = 743 mg/kg bw
ATE:
- LD50 or LC50-value, or
- Converted value (point estimate) for acute toxicity from Table 3.1.2 in Annex I,
relating to a value from a range test or to a classification category
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3. Step:conversion from hazard category to point estimate:
ATEmixture = 743 mg/kg bw
Table 3.1.2
Exposure route
Oral
(mg/kg bw)
Classification category or
experimentally obtained acute
toxicity range estimate
0 < category 1 ≤ 5
5 < category 2 ≤ 50
50 < category 3 ≤ 300
300 < category 4 ≤ 2000
Converted acute
toxicity point
estimate
0,5
5
100
500
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4. Step: classification of a mixture
Concentration
LD50 oral
Substance 1
1%
225 mg/kg
Substance 2
3%
100 mg/kg
Substance 3
10%
Water
76%
Acute tox, cat 3
100
ATEmixture
100
ATEmixture
=
225
+
100
ATE: 100
Ci
=∑ ATE
n
3
1
Classification
i
10
+
100
ATEmixture = 743 mg/kg bw
Classification: Acute tox. cat 4, oral
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Example:
Bridging principles
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Determine classification for the following mixture
(substantially similar mixtures)
Bridging principles
• Starting point: 2 mixtures, ingredients [A], [B] and [C]
• Mixture 1: [A] + [B]
• Mixture 2: [C] + [B]
• Concentration of [A] ≅ [C]
• Concentration of [B] similar in both mixtures
• B is a sensitiser!
• A and C are not sensitisers
• If either mixture (1) or (2) has been tested, the other can
be classified using bridging principles (substantially similar
mixtures)
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* Skin sensitiser
Not tested mixture (Product 6)
Tested mixture (Product 1)
Ingredient
weight %
Ingredient
weight %
Substance 1*
5.0
Substance 1*
4.8
Substance 2a
Substance 3
Substance 4
Substance 5
91.0
3.0
0.9
0.1
Substance 2b
Substance 3
Substance 4
Substance 5
91.2
3.0
0.9
0.1
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Additional information on the tested mixture
* Skin sensitiser
Weight % of
substance 1* in
product
Patch-tests in humans
occurrence of
sensitision
Product 1
5.0
0/298
Product 2
6.0
0/198
Product 3
6.0
0/307
Product 4
5.0
0/197
Product 5
2.5
0/103
Product
Sum: 0/1103
All 5 products tested in animals without a sensitising result
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solution
Non-tested product 6 is not classified as sensitising,
based on the test results on product 1 and the
additional information that supports this decision.
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solution
Tiered approach to classification of mixtures for acute toxicity
1) Testing (test data as primary source)
• whole mixture tested
• classification criteria applied as for substances
If no data
2) Bridging principles (Annex I, part 1) – sufficient data available for similar
mixture
• diluting
• batching
• concentrating of highly toxic mixtures
• interpolation within one toxicity category
• substantially similar mixtures
• aerosols
Also this is a possibility -> would result in product 6
being a sensitiser, because the conc. of substance
If even this is not possible
1* is over 1%
3) Classification based on concentration of ingredients
• formulas (acute toxicity)
• concentration limits (tables; other hazards apart from acute tox)
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EXAMPLE:
Classification for ENV hazards
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Environmental hazard:
Chronic Categories 1,2,3 and 4 - summation method (1)
Mixture:
Ingr. A
Ingr. B
Ingr. C
1%
10%
10%
Chronic Cat. 1
Chronic Cat. 1
Chronic Cat. 2
22
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EXAMPLE: Classification for ENV hazards
(Chronic Categories 1,2,3 and 4) - summation method (2)
Mixture:
Ingr. A
Ingr. B
Ingr. C
1%
10%
10%
Chronic Cat. 1
Chronic Cat. 1
Chronic Cat. 2
Step 1: use Table 4.1.2 of Annex 1(Classification of a mixture for chronic
(long term) hazards, based on summation of classified components
Mixture classified as Category Chronic 1, if
∑(Chronic Category 1 x M) ≥ 25%
23
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100
Step 2: use the formula ∑(Chronic Category 1 x M)
Ingr. A
Ingr. B
Ingr. C
1%
10%
10%
75
Chronic 3
50
Chronic 2
25
Chronic 1, M1
Chronic 1, M10
10% x 1 = 10%
1% x 10 = 10%
Chronic 1, M100
10% + 10% = 20%, which is < 25%.
Hence, mixture is not classified as Chronic 1.
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Step 3: use Table 4.1.2 of Annex 1(Classification of a mixture for
chronic (long term) hazards, based on summation of classified
components
Mixture classified as Category Chronic 2, if
∑(Chronic Category 1 x M x 10) + ∑(Chronic Category 2) ≥ 25%
25
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Step 4: use the formula ∑(Chronic Category 1 x M x 10) + ∑(Chronic Category 2)
Igr. A
Ingr. B
Ingr. C
1%
10%
10%
300
Chronic 3
Chronic 2
200
10%
Chronic 1, M1
10% x 1 x 10 = 100%
100
Chronic 1, M10
1% x 10 x 10 = 100%
Chronic 1, M100
100% + 100% + 10% = 210%, which is ≥ 25%.
Hence, mixture is classified as Chronic 2.
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Step 5: final classification (according Table 4.1.2., Annex I):
Ingr. A
Ingr. B
Ingr. C
1%
10%
10%
CHRONIC
CATEGORY 2,
H411
27
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Example: Translation - Mixtures
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Example:
Old (classification):
Mixture is not classified and contains:
98% water
2% of substance with R34 (causes burns)
New (translated classification):
1. Step: use the translation table – cannot be used
2. Step: use table 3.2.3 of Annex 1 to get Category:
NOTE: the NEW generic concentration limit is 1% but the corresponding limit of
OLD system is 5%!
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Table 3.2.3
Generic concentration limits of ingredients classified for skin corrosive/irritant
hazard (Category 1 or 2) that trigger classification of the mixture as
corrosive/irritant to skin
Sum of ingredients
classified as:
Skin Corrosive
Categories 1A, 1B, 1C
Concentration triggering classification of a mixture
as:
Skin Corrosive
Skin Irritant
Category 1 (see note
below)
Category 2
≥5%
≥ 1 % but < 5 %
Skin irritant Category 2
≥ 10 %
(10 × Skin Corrosive
Category 1A, 1B, 1C) +
Skin irritant Category 2
≥ 10 %
Skin Irritant; Cat.2
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3. Step: use table 3.2.5 of Annex 1 to get H statement :
4. Step: determine the final classification
Skin Irritant; Cat 2; H315 (Causes skin irritation)
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Mixture classification exercises
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Environmental hazard
Mixture X with components A to F:
Classification data is available for all
components of the mixture
Guidance on the Application of CLP Criteria,
section 4.1.4
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Information on ingredients, classification and concentration
Acute
aquatic
hazard
M
Long-term
aquatic
hazard
M
C (%)
A
Acute 1
10
Chronic 1
10
1
B
Acute 1
1
Chronic 2
-
3
C
Not
classified
-
Chronic 2
-
10
D
Not
classified
-
Chronic 3
-
10
E
Not
classified
-
Not
classified
-
10
F
Not
classified
-
Not
classified
-
66
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Which approach will you use?
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• Valid test data on the mixture as a whole (for all three
trophic levels) is not available.
• Valid test data on similar tested mixtures is not
available, either, meaning that any bridging principle
cannot be used.
Therefore, classification should be considered based on
individual components using the summation method.
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Acute aquatic hazard:
• Information on classification & associated M-factors
and the % of the components in the mixture are
available.
• Classify for acute hazard if: Σ (Acute 1 x M) ≥ 25%
• Is it?
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(1 x 10) + (3 x 1) = 13
which is <25%.
Hence, no classification for acute aquatic hazard.
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Long-term aquatic hazard
Step 1:
Classify as Chronic 1 if: Σ (Chronic 1 x M) ≥ 25% (if not, then go to
Step 2).
Step 2:
Classify as Chronic 2 if: Σ (10 x Chronic 1 x M) + Σ (Chronic 2) ≥
25% (if not, then go to Step 3).
Step 3:
Classify as Chronic 3 if: Σ (100 x Chronic 1 x M) + Σ (10 x Chronic 2)
+ Σ (Chronic 3) ≥ 25% (if not, then go to Step 4).
Step 4:
Classify as Chronic 4 if: Σ (Chronic 1) + Σ (Chronic 2) +
Σ (Chronic 3) + Σ (Chronic 4) ≥ 25%
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Using the classification of the components of the mixture:
Step 1: (1 x 10) = 10 (which is < 25% → Step 2).
Step 2: (10 x 1 x 10) + 3+10 = 113 (which is > 25%).
Hence, classify as Category Chronic 2.
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Aquatic hazard classification
Acute aquatic hazard: Not classified.
Long-term aquatic hazard: Category Chronic 2.
Labelling elements based on the classification:
Element
GHS Pictogram
Aquatic hazard
information that
could appear on
the label
GHS09
Signal Word
-
Hazard Statement
H411
Precautionary statement(s)
P273, P391, P501
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Mixture classification exercise 1:
classification for acute toxicity
Mixture
ingredients
Classification
(by ingredient)
Conc. (% w/w)
Info on testing
Animal tests
(rat, oral)
1
?
4
LD50: 125
mg/kg
2
-
92
N/A
3
?
3
LD50: 1500
mg/kg
4
-
0,8
N/A
5
?
0,2
LD50: 10 mg/kg
Physical properties have been tested -> no phys. hazards. No other test data.
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Mixture classification exercise 1: instructions
Check in CLP Annex I (pp. 81-87) the criteria for classification for acute
toxicity
1) Check component classifications in table 3.1.1 (based on LD50-values):
Component 3:
Component 5:
• Component 1:
2) Consider if formula 3.1.3.6.1 or 3.1.3.6.2.3 should be used?
• Unknown: ATEmixture
3) When you have ATEmixture, see table 3.1.1 for the classification of the mixture
4) Note the relevant ingredients from section 3.1.3.3 (p. 83) and table 1.1 (p. 38):
Additional labelling?
Hazard class
Generic cut-off values
to be taken into account
Acute Toxicity:
– Category 1-3
– Category 4
0,1 %
1%
Skin corrosion/Irritation
1 %[1]
Serious damage to eyes/eye
irritation
1 %[2]
Hazardous to Aquatic Environment
– Acute Category 1
– Chronic Category 1
– Chronic Category 2-4
0,1 %[3]
0,1 %[4]
1%
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Mixture classification exercise 1
3.1 Acute toxicity - ATE
• ATE: Acute Toxicity Estimate
• LD50- or LC50 -value [mg/kg bw]
OR
• Converted acute toxicity point estimate for the classification of mixtures
when using ATEmixture formulas
• Experimentally obtained acute toxicity range estimated
• Classification category
• If LD50 or LC50 for mixture or its components is not known, but
classification is known, a numerical value derived from
classification can be used (for calculating acute toxicity)
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Mixture classification exercise 1
3.1 Acute toxicity - ATE
Table 3.1.1
Acute toxicity hazard categories and
acute toxicity estimates (ATE) defining the respective categories
Category 1
Category 2
Category 3
Category 4
ATE ≤ 5
5 < ATE ≤ 50
50 < ATE ≤ 300
300 < ATE ≤ 2000
ATE ≤ 50
50 < ATE
≤ 200
200 < ATE
≤ 1000
1000 < ATE
≤ 2000
Gases (ppmV[1])
see:
Note (a)
Note (b)
ATE ≤ 100
100 < ATE
≤ 500
500 < ATE
≤ 2500
2500 < ATE
≤ 20000
Vapours (mg/l)
see:
Note (a)
Note (b)
Note (c)
ATE ≤ 0,5
0,5 < ATE
≤ 2,0
2,0 < ATE
≤ 10,0
10,0 < ATE
≤ 20,0
ATE ≤ 0,05
0,05 < ATE
≤ 0,5
0,5 < ATE ≤ 1,0
1,0 < ATE ≤ 5,0
Exposure Route
Oral (mg/kg bodyweight)
See Note (a)
Dermal (mg/kg
bodyweight)
See Note (a)
Dusts and Mists (mg/l)
see:
Note (a)
Note (b)
[1]
Gas concentrations are expressed in parts per million per volume (ppmV)
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Mixture classification exercise 1
3.1 Acute toxicity - ATE
Exposure routes
Table 3.1.2
Conversion from
experimentally obtained acute
toxicity range values
(or acute toxicity hazard
categories) to acute toxicity
point
estimates for classification
for the respective routes of
exposure
Classification Category or experimentally
obtained acute toxicity range estimate
Converted acute
toxicity point
estimate
(see Note 1)
Oral
(mg/kg
bodyweight)
0 < Category 1 ≤ 5
5 < Category 2 ≤ 50
50 < Category 3 ≤ 300
300 < Category 4 ≤ 2000
Dermal
(mg/kg
bodyweight)
0 < Category 1 ≤ 50
50 < Category 2 ≤ 200
200 < Category 3 ≤ 1000
1000 < Category 4 ≤ 2000
5
50
300
1100
Gases
(ppmV)
0 < Category 1 ≤ 100
100 < Category 2 ≤ 500
500 < Category 3 ≤ 2500
2500 < Category 4
10
100
700
4500
Vapours
(mg/l)
0 < Category 1 ≤ 0,5
0,5 < Category 2 ≤ 2,0
2,0 < Category 3 ≤ 10,0
10,0 < Category 4 ≤ 20,0
0,05
0,5
3
11
Dust/mist
(mg/l)
0< Category 1 ≤ 0,05
0,05 < Category 2 ≤ 0,5
0,5 < Category 3 ≤ 1,0
1,0 < Category 4 ≤ 5,0
≤ 20000
0,5
5
100
500
0,005
0,05
0,5
1,5
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Mixture classification exercise 1
3.1 Acute toxicity – ATE
Data available for all ingredients ⇒ Formula 1:
100
= ∑
ATE mix
•
•
•
•
n
Ci
ATE i
Ci= concentration of ingredient i
ATEi = Acute Toxicity Estimate of ingredient i
ATEmix = Acute Toxicity Estimate of mixture
n = number of ingredients
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Mixture classification exercise 1
3.1 Acute toxicity - ATE
Data is not available for all ingredients (ATE is not known) and the conc of
such an ingredient is > 10% ⇒ Formula 2:
100 – ( Σ Cunknown >10 %)
_______________________
ATE mix
•
•
•
•
•
=
Σ
n
Ci
_____
ATE i
Ci= concentration of ingredient i
Cunknown= conc. of ingredient of unknown acute toxicity
ATEi = Acute Toxicity Estimate of ingredient i
ATEmix = Acute Toxicity Estimate of mixture
n = number of ingredients
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Mixture classification exercise 1:
solution
Tiered approach to classification of mixtures for acute toxicity
1) Testing (test data as primary source)
• whole mixture tested
• classification criteria applied as for substances
If no data
2) Bridging principles (Annex I, part 1) – sufficient data available for similar mixture
• diluting
• batching
• concentrating of highly toxic mixtures
• interpolation within one toxicity category
• substantially similar mixtures
• aerosols
If even this is not possible
3) Classification based on concentration of ingredients
• formulas (acute toxicity)
• concentration limits (tables; other hazards apart from acute tox)
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Mixture classification exercise 1:
solution
General strategy
• Relevant concentration limits for each hazard
• For mixtures that must be classified according to the additivity principle (additive
effects: acute toxicity, skin and eye corrosion)
• Table 1.1 is not always enough
• Always check also criteria for mixture classif under respective hazard
• For each hazard: check possibilities to remove factors
• Ignore what is not relevant for the hazard in question
• Conc. below the value taken into account / generic cut-off value
• Not classified for that hazard
• Is the conc. to be classified using additivity formula (additive effects: acute
toxicity, skin and eye corrosion)
• Remember the limit values relevant for SDS
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Mixture classification exercise 1:
solution
Ingredient classification from Table 3.1.1:
• 1: category 3 (50-300 mg/kg)
• 3: category 4 (300-2000 mg/kg)
• 5: category 2 (5-50 mg/kg)
Mixture classification formula
(Section 3.1.3.6.2.3, unknown ingredients > 10%):
(100 – (Σ Cunknown if >10%))/ ATEmix = Σn Ci/ATEi
100 – 92/ ATEmix = 4/125 + 3/1500 + 0.2/10
8/ATEmix= 0.032 + 0.002 + 0.02 = 0.054
ATEmix = 148 mg/kg –> category 3 (acute toxicity)
• Additional labelling: ”92 % of the mixture consists of ingredients of
unknown toxicity” (Table 3.1.3, Note 2)
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Mixture classification exercise 1:
solution
Justification:
1. No available test data for mixture
2. Use of bridging principles is not possible (no classified similar mixture; section
3.1.3.5.1)
3. Classification can be based on section 3.1.3.6: mixture classification when data
NOT available for all components
4. Applying section 3.1.3.3(a), ”relevant ingredients” -> ingredient 4 is not taken
into account in calculating ATEmix, because its conc. is < 1%, and other info is
not available
5. Justification 4 cannot be used for ingredient 5, because the cut-off value for a
category 2 substance is 0.1% in Table 1.1
6. Total conc. of ingredients, whose toxicity is unknown (i.e. ingredient 2), is 92%
-> ATEmix formula in section 3.1.3.6.2.3 must be used (the over 10% rule)
7. ingredients 1, 3 and 5 are included in the formula, because their classification is
one of acute tox categories (3.1.3.6.1 a).
8. Calculation uses real LD50 values for substances 1, 3 and 5 (Table 3.1.1, note a)
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Labelling for the classification obtained
• Choose the pictograms, signal word, hazard- and
precautionary statements from Table 3.1.3
• Choose appr. 6 most suitable P-statements
• What else should there be on the label?
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Labelling
Acute toxicity cat. 3 + additional labelling ”92% of the mixture consists of
ingredients of unknown toxicity”
Statements from Table 3.1.3:
•
•
•
•
classification
•
Acute toxicity
category 3
•
P-statement on
prevention
•
P264, P270
•
P-statement on
response
•
P301 + P310
P321, P330
•
P-statement on
storage
•
P405
•
P-statement on
disposal
GHS-pictogram
•
Signal word
Hazard statement
•
Danger
H301: Toxic if
swallowed
•
P501
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Labelling
MODEL
Ingredient 1
Ingredient 3
Ingredient 5
92% of the mixture consists of
ingredients of unknown toxicity
DANGER
Toxic if swallowed.
(Keep out of reach of children.) Do not eat, drink or smoke when using this product. IF
SWALLOWED: Immediately call a POISON CENTER or doctor/physician. Store locked up.
Dispose of contents/container according to local regulations.
(5L)
Oy Tehdas Ab
Tehdaskatu 1
33100 Tampere
Tel. 03 111111
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Labelling
Justification:
•
Elements from Table 3.1.3
Most reasonable P-statements (CLP guidance (p.510), Art. 22+28, and
•
Guidance on labelling).
•
Volume must be mentioned if the product goes to consumer use, and if it not
mentioned elsewhere on the package. To products for consumer use also the
statement ”Keep out of reach of children” must be added. (Annex IV, Table
6.1).
•
Remember the child-resistant fastening and the tactile warning.
CLP, Art. 18: Product identifiers:
3. ... shall consist of both the following:
•
The trade name or the designation of the mixture;
•
The identity of all substances in the mixture that contribute to the classification
of the mixture as regards acute toxicity, skin corrosion or serious eye damage,
germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or
skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard.
If, in the case referred to in (b), this requirement leads to the provision of
multiple chemical names, a maximum of four chemical names shall suffice,
unless more than four names are needed to reflect the nature and the severity
of the hazards.
http://guidance.echa.europa.eu/docs/guidance_document/clp_en.pdf
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Mixture classification exercise 2
Classify for skin corrosion /irritation – mixture pH 2.5
Component
Skin corrosion/
irritation class.
Conc.
(% w/w)
Surfactant C
Cat 2
0,4
Surfactant D
Cat 2
3.0
Surfactant A
Cat 2
0,7
Cat 1A
3,0
Ethanol
Not classified
2
Water
Not classified
90.9
Hydrogen peroxide
SCL (specific conc. limit)
C ≥ 70 %: skin Cat 1A
50 % ≤ C < 70 %: skin Cat
1B
35 % ≤ C < 50 %: skin Cat
2
Mixture pH: 2.5 – 3.0
Mixture contains three surfactants, none of which are corrosive/ irritant under 1%
(CLP Annex VI does not have specific concentration levels), and classification is determined by additivity
principle
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Mixture classification exercise 2
Guide to solution
Decision logic in CLP guidance (p.238):
Note relevant ingredients!
GCL :
CLP Table 3.2.3
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Mixture classification exercise 2
Guide to solution
If the classification of a mixture can be determined with the additivity approach,
and if some of the components have specific concentration limits, the following
formula can be used:
Mixture is classified skin corrosive / irritant, if
• Sum (ConcA / clA) + (ConcB / clB) + ….+ (ConcZ / clZ) on ≥ 1
•
etc.
Where
ConcA = conc of substance A in the mixture
clA = conc limit (specific or generic) of substance A
ConcB = conc of substance B in the mixture
clB = conc limit (specific or generic) of substance B
• This formula can be found in the CLP Guidance (p.234) and in Directive 1999/45/EC.
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Mixture classification exercise 2
Guide to solution
General strategy
• Concentration limits to be taken into account for each hazard class
• For mixtures that must be classified using the additivity principle (additive effects: acute toxicity, skin and eye
corrosion /irritation)
• table 1.1. is not always enough
•
Always check also the criteria for that hazard under ”classification criteria for mixtures”
• For each hazard check the possibilities to remove factors
• ”off with what is not relevant for the hazard class”
•
•
•
Concentration under the relevant concentration limits
Not classified in that hazard class
Should that concentration be classified using the additivity principle (additive effects: acute toxicity, skin and eye corrosion
/irritation)
• Remember the concentration limits that must be given on the SDS
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Mixture classification exercise 2:
solution
• Classification according to pH is not applicable as pH>2
• Ethanol and water can be ignored, as they are not classified for the
hazard in question. Also surfactants A and C can be ignored,
because their concentration is below 1% (3.2.3.3.1. relevant
ingredients = concentration > 1%)
• No SCL has been determined for Surfactant D, so the generic
concentration limits from Table 3.2.3 will be used.
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Mixture classification exercise 2:
solution
Sum of ingredients classified as
Concentration triggering classification of a
mixture as:
Skin Corrosive
Skin Irritant
Category 1 (see note below)
Category 2
≥ 5%
≥ 1% but <
5%
Skin corrosive Categories 1A, 1B,
1C
Skin irritant Category 2
≥ 10%
(10 x Skin corrosive Category 1A,
1B, 1C) + Skin irritant Category 2
≥ 10%
Determine whether mixture belongs to skin category 1:
Mixture contains 3% hydrogen peroxide, which is the only substance in the mix in Cat. 1.
As this is below 50% (see SCL for hydrogen peroxide), the mixture is not classified Cat. 1 for
skin corrosion.
Determine whether mixture belongs to skin category 2:
(% hydrogen peroxide / SCL) + (% surfactant D / GCL) = (3/35) + (3/10) = 0.39  < 1
thus mixture is not classified in Cat. 2 for skin irritation.
(eye irritant?)
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Mixture classification exercise 2:
labelling according to classification
• Not classified => not hazardous
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Thank You.
Outi Tunnela
[email protected]