Page 1 of 32
Kit SDS Cover Sheet
Doc. ID: 300-7625: Rev. AC
. Revised (year/month/day) 2015/03/30
Product Information
Product Name
IRISpec™ CA/CB/CC SET NA
Part Number
800-7211
Additional Product Information
For In Vitro Diagnostic Use. See product literature for details.
Components
Description
IRISpec™ CA
IRISpec™ CB
IRISpec™ CC
Transport Information
Transportation of this product is not regulated under ICAO, IMDG, US DOT, European ADR or Canadian TDG.
©2015 Iris Diagnostics
Global SDS – English
Page 2 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
Section 1 Identication of the Substance/mixture and of the Company/undertaking
1.1
1.2
1.3
Product Identier
Product Name
IRISpec™ CA
Component of P/N 800-7211
Part Number
Relevant identied uses of the substance or mixture and uses advised against
For In Vitro Diagnostic Use. See product literature for details.
Product Use
Details of the supplier of the safety data sheet
Manufacturer
EC REP Address
IRIS International, Inc.
9172 Eton Avenue
Chatsworth, CA 91311-5874, U.S.A.
Tel: 800-776-4747
818-527-7000
[email protected]
1.4
mdi Europa GmbH
Langenhagener Str. 71
30855 Hannover-Langenhagen
Germany
+49-511-39089530
e-mail address
Emergency telephone number
Chemtrec Emergency Tel No. U.S.A. 800-424-9300, International (001)
Telephone number (24H)
703-527-3887
Distributor and Emergency Phone No.
(800) 776-4747
Section 2 Hazards Identication
2.1 Classication of substance or mixture
Product Description
Mixture
Amber to greenish; Clear; Liquid; Odorless
Classication according to EC 1272/2008 (CLP/GHS)
Not classied as hazardous per EC 1272/2008 (CLP/GHS)
Classication according to EC Directives 1999/45/EC and 67/548/EEC
Not classied as dangerous per EC Directives (1999/45/EC and 67/548 EEC)
Classication according to US-OSHA (HCS 29 CFR 1910.1200) and UN GHS
Toxic to Reproductive Category 1
©2015 Iris Diagnostics
Global SDS – English
Page 3 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CA
Section 2 Hazards Identication (Continued)
2.2 Label Elements
According to EC 1272/2008 (CLP/GHS), US-OSHA and UN GHS
Hazardous Ingredients
Sodium Borate Decahydrate
Pictogram
Signal Word
DANGER
Hazard Statements
H360 May damage fertility or the unborn child.
Precautionary Statements
P201 Obtain special instructions before use.
P280 Wear protective gloves, protective clothing and eye/face protection.
P308+P313 IF exposed or concerned: Get medical advice/attention.
P405 Store locked up.
P501 Dispose of contents/container in accordance with local/national regulations
Product label will display most signicant precautionary statements.
2.3 Other hazards
This product contains material(s) of animal origin. Observe general safety
guidelines for protection when handling this product.
Results of PBT and vPvB assessment
PBT: Not applicable.
vPvB: Not applicable.
See Section 11 Toxicological Information for more detailed health information.
Section 3 Composition and Information on Ingredients
3.2 Mixtures
Hazardous Ingredients:
Chemical Name
Sodium Borate Decahydrate
CAS # 1303-96-4
EINECS # 237-560-2
Index # 005-011-01-1
Hazard Classication of Pure Ingredients
% by wt.
1 - 2
EU-67/548/EEC
EU 1272/2008
CLP/GHS
GHS
T;R60-61
Repr. Cat. 2
Repr. 1B
H360
Acute Tox. Dermal
5
Acute Tox. Oral 5
Repr. 1B
Skin Irrit. 3
H303; H313; H316;
H360
SVHC - Substance of very high concern
See section 8 for available Occupational exposure limits
See Section 15 for additional regulatory information
See Section 16 for hazard class, hazard statements and risk phrase description
©2015 Iris Diagnostics
Global SDS – English
SVHC
Page 4 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CA
Section 4 First Aid Measures
4.1
Description of rst aid measures
If product is inhaled, move exposed individual to fresh air. If individual is not
Inhalation
breathing, begin articial respiration immediately and obtain medical attention.
4.2
Eye Contact
If product enters eyes, wash eyes gently under running water for 15 minutes
or longer, making sure that the eyelids are held open. If pain or irritation occur,
obtain medical attention.
Skin Contact
In case of skin contact, ush with copious amounts of water for at least 15
minutes. Remove contaminated clothing and shoes. If pain or irritation occur,
obtain medical attention.
Ingestion
If ingested, wash mouth out with water. If irritation or discomfort occurs, seek
medical attention.
Most important symptoms and effects, both acute and delayed
May damage fertility or the unborn child.
See Section 11 Toxicological Information for more detailed health information.
4.3
Indication of any immediate medical attention and special treatment needed
No further relevant information available.
Section 5 Fire Fighting Measures
Flammable Properties
Nonammable aqueous solution.
5.1
Extinguishing Media
In case of re use carbon dioxide (CO2), dry chemical, water spray or foam.
For large res use extinguishing media suitable for surrounding re.
5.2
Special hazards arising from the substance or mixture
Special Fire and Explosion Hazards
No special hazards determined.
Hazardous Combustion Products
No combustion products posing signicant hazards are expected from this
product (an aqueous solution).
5.3
5.4
Advice for re ghters
Protective Equipment
Additional information
Self-contained breathing apparatus is recommended for reghters in all
chemical re situations.
No further relevant information available.
Section 6 Accidental Release Measures
6.1
Personal precautions, protective equipment and emergency procedures
This product contains a material of animal origin. Observe general safety
Personal Precautions
guidelines for protection during clean up procedures.
Wear protective gloves, protective clothing and eye/face protection.
©2015 Iris Diagnostics
Global SDS – English
Page 5 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CA
Section 6 Accidental Release Measures (Continued)
6.2
Environmental Precautions
6.3
Methods and material for containment and cleaning up
As a precautionary measure, treat spilled material with a 1:10 bleach/water
Spill and Leak Procedures
Contain spill to prevent migration.
Do not allow the undiluted product to enter sewers/surface or ground water.
solution. Absorb liquid and place in container suitable for disposal. Avoid
generation of aerosols during clean up. Comply with applicable waste disposal
regulations.
6.4
Reference to other sections
Refer sections 8 and 13.
Section 7 Handling and Storage
7.1
Precautions for safe handling This product should be handled as though capable of transmitting infectious
diseases. Universal precautions should be followed when using this product.
7.2
Conditions for safe storage, including any incompatibilities
Store at 2 to 8°C , as directed on the product label.
To maintain product quality, store according to the instructions in the product
labeling.
Store away from strong acids, strong bases, strong oxidizers and incompatible
materials (section 10).
7.3
Specic end uses
No further relevant information available.
Section 8 Exposure Controls and Personal Protection
8.1
Control parameters
Exposure Limits
US OSHA
None established
ACGIH
Sodium Borate Decahydrate
CAS # 1303-96-4
DFG MAK
6 mg/m3 STEL (inhalable fraction) (listed under Borate compounds, inorganic); 2
mg/m3 TWA (inhalable fraction) (listed under Borate compounds, inorganic)
None established
Ireland
Sodium Borate Decahydrate
5 mg/m3 TWA
CAS # 1303-96-4
IOELVs
None established
NIOSH
Sodium Borate Decahydrate
5 mg/m3 TWA
CAS # 1303-96-4
Japan
None established
©2015 Iris Diagnostics
Global SDS – English
Page 6 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CA
Section 8 Exposure Controls and Personal Protection (Continued)
8.2
Exposure controls
Engineering Controls
No special engineering controls are required. Use with good general ventilation.
Eye Protection
Safety glasses or chemical goggles should be worn to prevent eye contact.
Refer U.S. OSHA 29 CFR 1910.133, European Standard EN166 or appropriate
government standards.
Skin Protection
Impervious gloves, such as Nitrile or equivalent, should be worn to prevent skin
contact.
Refer U.S. OSHA 29 CFR 1910.138, European Standard EN374 or appropriate
government standards.
Respiratory Protection
Under normal conditions, the use of this product should not require respiratory
protection. If overexposure should occur and ventilation is not adequate to
maintain airborne concentrations at acceptable levels, the use of respiratory
protection should be evaluated by a qualied professional.
Section 9 Physical and Chemical Properties
9.1
9.2
Information on basic physical and chemical properties
Physical State
Liquid
Specic Gravity
(Water=1.0)
Color
Amber to greenish
Solubility
Transparency
Clear
Water
Miscible
Odor
Odorless
Organic
Not determined
pH
8-9
Partition coefcient:
n-octanol/water
Not determined
Freezing Point
Not determined
Auto-ignition Temp.
Not applicable
Boiling Point
Not determined
Decomposition
Temperature
Not determined
Flash Point
Not applicable
Percent Volatiles
Not applicable
Evaporation Rate
Not determined
Vapor Pressure
Not determined
Flammability (Solid, Gas)
Not applicable
Viscosity
Not determined
Flammability Limits
Not applicable
Explosive Properties
Not applicable
Vapor Density
Not determined
Oxidizing Properties
Not applicable
Odor Threshold
Not applicable
Other Information
No further relevant information available.
Section 10 Stability and Reactivity
10.1 Reactivity
No further relevant information available.
©2015 Iris Diagnostics
Global SDS – English
1.009 - 1.019 @20°C
Page 7 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CA
Section 10 Stability and Reactivity (Continued)
10.2 Chemical Stability
The product is stable in accordance with recommended storage conditions.
10.3 Possibility of hazardous reactions
No further relevant information available.
10.4 Conditions to Avoid
Avoid exposure to heat and direct sunlight.
To maintain product performance keep away from strong acids, strong bases,
strong oxidizers.
10.5 Incompatible materials
No further relevant information available.
10.6 Hazardous Decomposition Products
No decomposition products posing signicant hazards would be expected from
this product (an aqueous solution).
Section 11 Toxicological Information
11.1 Information on toxicological effects
Toxicity Data for Hazardous Ingredients
Sodium Borate Decahydrate
Oral LD50 Rat 2660 mg/kg
CAS # 1303-96-4
Primary Routes of Exposure
Common routes of entry include inhalation, ingestion and eye/skin contact.
Specic paths of concern for potentially infectious materials are skin puncture,
contact with broken skin, contact with mucous membranes and inhalation of
aerosolized material.
Skin Corrosion/Irritation
No data available.
Serious eye damage/eye
irritation
No data available.
Respiratory/skin sensitization No data available.
Carcinogenicity
No ingredients in this product are listed as carcinogens by ACGIH, IARC, NTP,
OSHA or 1272/2008 EC regulation.
Germ cell mutagenicity
No data available.
Reproductive Toxicity
May damage fertility or the unborn child.
Specic target organ toxicity – single exposure
No data available.
Specic target organ toxicity – repeated exposure
No data available.
Aspiration hazard
No data available.
Other Information
This product contains material of animal origin and should be considered as
potentially capable of transmitting infectious diseases.
©2015 Iris Diagnostics
Global SDS – English
Page 8 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CA
Section 12 Ecological Information
12.1 Ecotoxicity
Fresh Water Species
Microtox
Water Flea
Fresh Water Algae
12.2 Persistence and degradability
No
No
No
No
information
information
information
information
available.
available.
available.
available.
12.3 Bioaccumulation
Not determined for the product.
12.4 Mobility in soil
Not determined for the product.
Not determined for the product.
12.5 Results of PBT and vPvB assessment
Not determined for the product. PBT: Not applicable, vPvB: Not applicable.
12.6 Other Adverse Effects
No further relevant information available.
Section 13 Disposal Considerations
13.1 Waste treatment methods
Product Waste Disposal
Chemical residues and remains should be routinely handled as special waste. This
must be disposed of in compliance with anti-pollution and other laws of the country
concerned. To ensure compliance we recommend that you contact the relevant
(local) authorities and/or an approved waste-disposal company for information.
Dispose of as potentially biohazardous waste and in compliance with
anti-pollution and other laws of the country concerned. To ensure compliance we
recommend that you contact the relevant (local) authorities and/or and approved
waste-disposal company for information.
13.2 Additional information
Suggested European waste catalogue 18 01 07 - chemicals other than those
mentioned in 18 01 06. Dispose in accordance with national, state and local
waste regulations.
Section 14 Transport Information
Transportation of this product is not regulated under ICAO, IMDG, US DOT, European ADR or Canadian TDG.
Section 15 Regulatory Information
15.1 Safety, health and environmental regulations/legislation specic for the substance or mixture
US Federal and State Regulations
SARA 313
No ingredients listed.
CERCLA RG’s, 40 CFR 302.4
Sodium Hydroxide is listed.
California Proposition 65
No ingredients listed.
©2015 Iris Diagnostics
Global SDS – English
Page 9 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CA
Section 15 Regulatory Information (Continued)
Massachusetts MSL
Glycerol is listed.
Glutaraldehyde is listed.
Sodium Borate Decahydrate is listed.
Sodium Hydroxide is listed.
New Jersey Dept. of Health RTK List
Glycerol is listed.
Glutaraldehyde is listed.
Sodium Borate Decahydrate is listed.
Sodium Hydroxide is listed.
Pennsylvania RTK
Glycerol is listed.
Glutaraldehyde is listed.
Sodium Borate Decahydrate is listed.
Sodium Hydroxide is listed.
EU Regulations
This SDS complies with EC Regulations 1907/2006 (REACH) and amendments.
Water Hazard Class (Germany) WGK 1, low water endangering
REACH 1907/2006 EC - Annex XIV - list of substances subject to authorization.
No ingredients listed.
According to EC Directives (1999/45/EC and 67/548 EEC)
Not classied as dangerous per EC Directives (1999/45/EC and 67/548 EEC)
Canada
This product is exempt from WHMIS label and SDS requirements.
Not applicable
PIN
Ingredients on Ingredient Disclosure List
Citric Acid
Glutaraldehyde
Sodium Borate Decahydrate
Sodium Hydroxide
Ingredients with unknown toxicological properties
Product is exempt
15.2 Chemical Safety Assessment A Chemical Safety Assessment has not been carried out.
Some hazardous ingredients listed in Section 15 are below OSHAs and WHMIS’ 1.0% w/w (0.1% for carcinogens) or EU’s ingredient specic
concentrations required for reporting in Section 3.
©2015 Iris Diagnostics
Global SDS – English
Page 10 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CA
Section 16 Other Information
Safety Ratings
Flammability:
Health:
Reactivity with Water:
Contact:
0
3
0
3
Code
0=None
1=Slight
2=Caution
3=Severe
Updated to GHS.
Revision Changes
Hazard Class, hazard statements and risk phrase description from section 3
Abbreviations and Acronyms
T - Toxic
Repr. Cat. 2 - Toxic for Reproduction Category 2
R60 May impair fertility.
R61 May cause harm to unborn child.
Acute Tox. Dermal 5 - Acute Toxicity Dermal, Category 5
Acute Tox. Oral 5 - Acute Toxicity Oral, Category 5
Skin Irrit. 3 - Skin Irritation Category 3
Repr. 1B - Toxic to Reproductive Category 1B
H303 - May be harmful if swallowed
H313 - May be harmful In contact with skin
H316 - Causes mild skin irritation.
H360 - May damage fertility or the unborn child.
ACGIH - American Conference of Governmental Industrial Hygienists
ADR - European Agreement Concerning The International Carriage Of Dangerous
Goods By Road
CERCLA - The Comprehensive Environmental Response, Compensation, and
Liability Act
CLP - Classication, Labeling and Packaging
DFGMAK - Republic Germany’s maximum exposure limit
GHS - Globally Harmonized System
HCS - Hazard Communication Standard
IARC - International Agency for Research on Cancer
IATA - International Air Transport Association
ICAO - International Civil Aviation Organization
IMDG - International Maritime Dangerous Goods
IOELVs - European Unions’ Indicative Occupational Exposure Limit Values
NIOSH - National Institute for Occupational Safety and Health
NTP - National Toxicology Program
OSHA - Occupational Safety and Health Administration
PBT - Persistent bioaccumulative and toxic substances
SARA - Superfund Amendments and Reauthorization Act
TDG - Canadian Transportation Of Dangerous Goods Regulations.
UN GHS - United Nations Globally Harmonized System
US DOT - United States Department of Transportation
WHMIS - Workplace Hazardous Material Information System
vPvB - Very persistent and very bioaccumulative substances
©2015 Iris Diagnostics
Global SDS – English
Page 11 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CA
Section 16 Other Information (Continued)
LD50 - Lethal Dose, 50%
For further information, please contact your local Iris Diagnostics representative.
WHILE IRIS DIAGNOSTICS BELIEVES THE INFORMATION CONTAINED HEREIN IS VALID AND ACCURATE, MAKES NO WARRANTY OR REPRESENTATION AS TO ITS VALIDITY, ACCURACY, OR
CURRENCY. IRIS DIAGNOSTICS SHALL NOT BE LIABLE OR OTHERWISE RESPONSIBLE IN ANY WAY FOR USE OF EITHER THIS INFORMATION OR MATERIALS TO WHICH IT APPLIES. DISPOSAL
OF HAZARDOUS MATERIALS MAY BE SUBJECT TO LOCAL LAWS OR REGULATIONS.
©2015 Iris Diagnostics
Global SDS – English
Page 12 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
Section 1 Identication of the Substance/mixture and of the Company/undertaking
1.1
1.2
1.3
Product Identier
Product Name
IRISpec™ CB
Component of P/N 800-7211
Part Number
Relevant identied uses of the substance or mixture and uses advised against
For In Vitro Diagnostic Use. See product literature for details.
Product Use
Details of the supplier of the safety data sheet
Manufacturer
EC REP Address
IRIS International, Inc.
9172 Eton Avenue
Chatsworth, CA 91311-5874, U.S.A.
Tel: 800-776-4747
818-527-7000
[email protected]
1.4
mdi Europa GmbH
Langenhagener Str. 71
30855 Hannover-Langenhagen
Germany
+49-511-39089530
e-mail address
Emergency telephone number
Chemtrec Emergency Tel No. U.S.A. 800-424-9300, International (001)
Telephone number (24H)
703-527-3887
Distributor and Emergency Phone No.
(800) 776-4747
Section 2 Hazards Identication
2.1 Classication of substance or mixture
Product Description
Mixture
Yellow; Clear; Liquid; Characteristic odor
Classication according to EC 1272/2008 (CLP/GHS)
Not classied as hazardous per EC 1272/2008 (CLP/GHS)
Classication according to EC Directives 1999/45/EC and 67/548/EEC
Not classied as dangerous per EC Directives (1999/45/EC and 67/548 EEC)
Classication according to US-OSHA (HCS 29 CFR 1910.1200) and UN GHS
Toxic to Reproductive Category 1
©2015 Iris Diagnostics
Global SDS – English
Page 13 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CB
Section 2 Hazards Identication (Continued)
2.2 Label Elements
According to EC 1272/2008 (CLP/GHS), US-OSHA and UN GHS
Hazardous Ingredients
Boric Acid
Subtilisin
Pictogram
Signal Word
DANGER
Hazard Statements
H360 May damage fertility or the unborn child.
EUH208 May produce an allergic reaction.
Precautionary Statements
P201 Obtain special instructions before use.
P280 Wear protective gloves, protective clothing and eye/face protection.
P308+P313 IF exposed or concerned: Get medical advice/attention.
P405 Store locked up.
P501 Dispose of contents/container in accordance with local/national regulations
Product label will display most signicant precautionary statements.
2.3 Other hazards
This product contains material(s) of animal origin. Observe general safety
guidelines for protection when handling this product.
Results of PBT and vPvB assessment
PBT: Not applicable.
vPvB: Not applicable.
See Section 11 Toxicological Information for more detailed health information.
Section 3 Composition and Information on Ingredients
3.2 Mixtures
Hazardous Ingredients:
Chemical Name
Acetone
Hazard Classication of Pure Ingredients
% by wt.
EU-67/548/EEC
EU 1272/2008
CLP/GHS
GHS
1 - 5
F;R11
Xi;R36-66-67
Eye Irrit. 2
Flam. Liq. 2
STOT SE 3
H225; H319; H336
Eye Irrit. 2
Flam. Liq. 2
STOT SE 3
H225; H319; H336
3, 8
0.1 - 1
T;R60-61
Repr. Cat. 2
Repr. 1B
H360
Acute Tox. Dermal
5
Acute Tox. Oral 5
Repr. 1B
Skin Irrit. 3
H303; H313; H316;
H360
SVHC
CAS # 67-64-1
EINECS # 200-662-2
Index # 606-001-00-8
Boric Acid
CAS # 10043-35-3
EINECS # 233-139-2
Index # Not available
©2015 Iris Diagnostics
Global SDS – English
Page 14 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CB
Section 3 Composition and Information on Ingredients (Continued)
Subtilisin
< 0.1
Xn;R37/38-41-42
CAS # 9014-01-1
EINECS # 232-752-2
Index # 647-012-00-8
Eye Dam. 1
Resp. Sens. 1
STOT SE 3
Skin Irrit. 2
H315; H318; H334;
H335
Acute Tox. Oral 5
Eye Dam. 1
Resp. Sens. 1
STOT SE 3
Skin Irrit. 2
H303; H315; H318;
H334; H335
15, 8
15 - May produce an allergic reaction.
3 - Health hazard
8 - Present at concentration below the cut-off limits.
SVHC - Substance of very high concern
See section 8 for available Occupational exposure limits
See Section 15 for additional regulatory information
See Section 16 for hazard class, hazard statements and risk phrase description
Section 4 First Aid Measures
4.1
Description of rst aid measures
If product is inhaled, move exposed individual to fresh air. If individual is not
Inhalation
breathing, begin articial respiration immediately and obtain medical attention.
4.2
Eye Contact
If product enters eyes, wash eyes gently under running water for 15 minutes
or longer, making sure that the eyelids are held open. If pain or irritation occur,
obtain medical attention.
Skin Contact
In case of skin contact, ush with copious amounts of water for at least 15
minutes. Remove contaminated clothing and shoes. If pain or irritation occur,
obtain medical attention.
Ingestion
If ingested, wash mouth out with water. If irritation or discomfort occurs, seek
medical attention.
Most important symptoms and effects, both acute and delayed
May damage fertility or the unborn child.
This product contains a sensitizing substance below concentration limit, may
produce an allergic reaction in some people. Refer Section 3.
See Section 11 Toxicological Information for more detailed health information.
4.3
Indication of any immediate medical attention and special treatment needed
No further relevant information available.
Section 5 Fire Fighting Measures
Flammable Properties
Nonammable aqueous solution.
5.1
Extinguishing Media
In case of re use carbon dioxide (CO2), dry chemical, water spray or foam.
For large res use extinguishing media suitable for surrounding re.
5.2
Special hazards arising from the substance or mixture
Special Fire and Explosion Hazards
No special hazards determined.
©2015 Iris Diagnostics
Global SDS – English
Page 15 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CB
Section 5 Fire Fighting Measures (Continued)
Hazardous Combustion Products
No combustion products posing signicant hazards are expected from this
product (an aqueous solution).
5.3
5.4
Advice for re ghters
Protective Equipment
Self-contained breathing apparatus is recommended for reghters in all
chemical re situations.
No further relevant information available.
Additional information
Section 6 Accidental Release Measures
6.1
Personal precautions, protective equipment and emergency procedures
This product contains a material of animal origin. Observe general safety
Personal Precautions
guidelines for protection during clean up procedures.
Wear protective gloves, protective clothing and eye/face protection.
6.2
Environmental Precautions
6.3
Methods and material for containment and cleaning up
As a precautionary measure, treat spilled material with a 1:10 bleach/water
Spill and Leak Procedures
Contain spill to prevent migration.
Do not allow the undiluted product to enter sewers/surface or ground water.
solution. Absorb liquid and place in container suitable for disposal. Avoid
generation of aerosols during clean up. Comply with applicable waste disposal
regulations.
6.4
Reference to other sections
Refer sections 8 and 13.
Section 7 Handling and Storage
7.1
Precautions for safe handling This product should be handled as though capable of transmitting infectious
diseases. Universal precautions should be followed when using this product.
7.2
Conditions for safe storage, including any incompatibilities
Store at 2 to 8°C , as directed on the product label.
To maintain product quality, store according to the instructions in the product
labeling.
Store away from strong acids, strong bases, strong oxidizers and incompatible
materials (section 10).
7.3
Specic end uses
No further relevant information available.
Section 8 Exposure Controls and Personal Protection
8.1
Control parameters
Exposure Limits
©2015 Iris Diagnostics
Global SDS – English
Page 16 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CB
Section 8 Exposure Controls and Personal Protection (Continued)
US OSHA
Acetone
1000 ppm TWA; 2400 mg/m3 TWA
CAS # 67-64-1
ACGIH
Acetone
750 ppm STEL; 500 ppm TWA
CAS # 67-64-1
Subtilisin
0.00006 mg/m3 Ceiling (as as crystalline active enzyme) (listed under Subtilisins)
CAS # 9014-01-1
Boric Acid
CAS # 10043-35-3
6 mg/m3 STEL (inhalable fraction) (listed under Borate compounds, inorganic); 2
mg/m3 TWA (inhalable fraction) (listed under Borate compounds, inorganic)
DFG MAK
Acetone
1000 ppm Peak; 2400 mg/m3 Peak; 500 ppm TWA MAK; 1200 mg/m3 TWA MAK
CAS # 67-64-1
Boric Acid
CAS # 10043-35-3
10 mg/m3 Peak (as B) (inhalable fraction); 10 mg/m3 TWA MAK (inhalable
fraction) (as B)
Ireland
Acetone
500 ppm TWA; 1210 mg/m3 TWA
CAS # 67-64-1
Subtilisin
CAS # 9014-01-1
0.00006 mg/m3 TWA (Proteolytic enzymes) (as 100% pure crystalline enzyme);
0.00006 mg/m3 STEL
IOELVs
Acetone
500 ppm TWA; 1210 mg/m3 TWA
CAS # 67-64-1
NIOSH
Acetone
2500 ppm IDLH (10% LEL); 250 ppm TWA; 590 mg/m3 TWA
CAS # 67-64-1
Subtilisin
0.00006 mg/m3 STEL (60 min) (listed under Subtilisins)
CAS # 9014-01-1
Japan
Acetone
200 ppm OEL; 470 mg/m3 OEL
CAS # 67-64-1
8.2
Exposure controls
Engineering Controls
Eye Protection
No special engineering controls are required. Use with good general ventilation.
Safety glasses or chemical goggles should be worn to prevent eye contact.
Refer U.S. OSHA 29 CFR 1910.133, European Standard EN166 or appropriate
government standards.
©2015 Iris Diagnostics
Global SDS – English
Page 17 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CB
Section 8 Exposure Controls and Personal Protection (Continued)
Skin Protection
Impervious gloves, such as Nitrile or equivalent, should be worn to prevent skin
contact.
Refer U.S. OSHA 29 CFR 1910.138, European Standard EN374 or appropriate
government standards.
Respiratory Protection
Under normal conditions, the use of this product should not require respiratory
protection. If overexposure should occur and ventilation is not adequate to
maintain airborne concentrations at acceptable levels, the use of respiratory
protection should be evaluated by a qualied professional.
Section 9 Physical and Chemical Properties
9.1
9.2
Information on basic physical and chemical properties
Physical State
Liquid
Specic Gravity
(Water=1.0)
Color
Yellow
Solubility
Transparency
Clear
Water
Miscible
Odor
Characteristic odor
Organic
Not determined
pH
6.0 - 6.5
Partition coefcient:
n-octanol/water
Not determined
Freezing Point
Not determined
Auto-ignition Temp.
Not applicable
Boiling Point
Not determined
Decomposition
Temperature
Not determined
Flash Point
Not applicable
Percent Volatiles
Not determined
Evaporation Rate
Not determined
Vapor Pressure
Not determined
Flammability (Solid, Gas)
Not applicable
Viscosity
Not determined
Flammability Limits
Not applicable
Explosive Properties
Not applicable
Vapor Density
Not determined
Oxidizing Properties
Not applicable
Odor Threshold
Acetone 62 ppm geometric mean air odor threshold = (detectable); 130 ppm
geometric mean air odor threshold = (recognizable)
Other Information
1.010 - 1.020 @20°C
No further relevant information available.
Section 10 Stability and Reactivity
10.1 Reactivity
No further relevant information available.
10.2 Chemical Stability
The product is stable in accordance with recommended storage conditions.
10.3 Possibility of hazardous reactions
No further relevant information available.
©2015 Iris Diagnostics
Global SDS – English
Page 18 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CB
Section 10 Stability and Reactivity (Continued)
10.4 Conditions to Avoid
Avoid exposure to heat and direct sunlight.
To maintain product performance keep away from strong acids, strong bases,
strong oxidizers.
10.5 Incompatible materials
No further relevant information available.
10.6 Hazardous Decomposition Products
No decomposition products posing signicant hazards would be expected from
this product (an aqueous solution).
Section 11 Toxicological Information
11.1 Information on toxicological effects
Toxicity Data for Hazardous Ingredients
Acetone
Oral LD50 Rat 5800 mg/kg
CAS # 67-64-1
Subtilisin
Oral LD50 Rat 3700 mg/kg
CAS # 9014-01-1
Boric Acid
CAS # 10043-35-3
Oral LD50 Rat 2660 mg/kg; Inhalation LC50 Rat >0.16 mg/L 4 h; Dermal LD50
Rabbit >2000 mg/kg
Primary Routes of Exposure
Common routes of entry include inhalation, ingestion and eye/skin contact.
Specic paths of concern for potentially infectious materials are skin puncture,
contact with broken skin, contact with mucous membranes and inhalation of
aerosolized material.
Skin Corrosion/Irritation
No data available.
Serious eye damage/eye
irritation
No data available.
Respiratory/skin sensitization This product contains a sensitizing substance below concentration limit, may
produce an allergic reaction in some people. Refer Section 3.
Carcinogenicity
No ingredients in this product are listed as carcinogens by ACGIH, IARC, NTP,
OSHA or 1272/2008 EC regulation.
Germ cell mutagenicity
No data available.
Reproductive Toxicity
May damage fertility or the unborn child.
Specic target organ toxicity – single exposure
No data available.
Specic target organ toxicity – repeated exposure
No data available.
Aspiration hazard
No data available.
Other Information
This product contains material of animal origin and should be considered as
potentially capable of transmitting infectious diseases.
©2015 Iris Diagnostics
Global SDS – English
Page 19 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CB
Section 12 Ecological Information
12.1 Ecotoxicity
Fresh Water Species
Acetone
96 h LC50 Oncorhynchus mykiss: 4.74 - 6.33 mL/L; 96 h LC50 Pimephales
promelas: 6210 - 8120 mg/L [static]; 96 h LC50 Lepomis macrochirus: 8300 mg/L
No information available.
CAS # 67-64-1
Microtox
Water Flea
Acetone
48 h EC50 Daphnia magna: 10294 - 17704 mg/L [Static]; 48 h EC50 Daphnia
magna: 12600 - 12700 mg/L
48 h EC50 Daphnia magna: 115 - 153 mg/L
CAS # 67-64-1
Boric Acid
CAS # 10043-35-3
No information available.
Fresh Water Algae
12.2 Persistence and degradability Not determined for the product.
12.3 Bioaccumulation
Not determined for the product.
12.4 Mobility in soil
Not determined for the product.
12.5 Results of PBT and vPvB assessment
Not determined for the product. PBT: Not applicable, vPvB: Not applicable.
12.6 Other Adverse Effects
No further relevant information available.
Section 13 Disposal Considerations
13.1 Waste treatment methods
Product Waste Disposal
13.2 Additional information
Chemical residues and remains should be routinely handled as special waste. This
must be disposed of in compliance with anti-pollution and other laws of the country
concerned. To ensure compliance we recommend that you contact the relevant
(local) authorities and/or an approved waste-disposal company for information.
Dispose of as potentially biohazardous waste and in compliance with
anti-pollution and other laws of the country concerned. To ensure compliance we
recommend that you contact the relevant (local) authorities and/or and approved
waste-disposal company for information.
Suggested European waste catalogue 18 01 07 - chemicals other than those
mentioned in 18 01 06. Dispose in accordance with national, state and local
waste regulations.
Section 14 Transport Information
Transportation of this product is not regulated under ICAO, IMDG, US DOT, European ADR or Canadian TDG.
Section 15 Regulatory Information
15.1 Safety, health and environmental regulations/legislation specic for the substance or mixture
©2015 Iris Diagnostics
Global SDS – English
Page 20 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CB
Section 15 Regulatory Information (Continued)
US Federal and State Regulations
SARA 313
Sodium Nitrite is subject to reporting requirements of Section 313, Title III of
SARA. 1.0 % de minimis concentration
CERCLA RG’s, 40 CFR 302.4
Acetone is listed.
Sodium Nitrite is listed.
California Proposition 65
Ethyl Alcohol has been identied by the State of California to cause cancer and
reproductive harm. The State of California has adopted a regulation which
requires a warning be given to individual who may be exposed to chemicals
identied by the State to cause cancer or reproductive harm.
WARNING: This product contains a chemical known to the State of California to
cause cancer and reproductive harm.
Massachusetts MSL
Glycerol is listed.
Ethyl Alcohol is listed.
Acetone is listed.
Glutaraldehyde is listed.
Sodium Nitrite is listed.
New Jersey Dept. of Health RTK List
Glycerol is listed.
Ethyl Alcohol is listed.
Acetone is listed.
Glutaraldehyde is listed.
Sodium Nitrite is listed.
Pennsylvania RTK
Glycerol is listed.
Ethyl Alcohol is listed.
Acetone is listed.
Glutaraldehyde is listed.
Sodium Nitrite is listed.
EU Regulations
This SDS complies with EC Regulations 1907/2006 (REACH) and amendments.
Water Hazard Class (Germany) WGK 1, low water endangering
REACH 1907/2006 EC - Annex XIV - list of substances subject to authorization.
No ingredients listed.
According to EC Directives (1999/45/EC and 67/548 EEC)
Not classied as dangerous per EC Directives (1999/45/EC and 67/548 EEC)
Canada
This product is exempt from WHMIS label and SDS requirements.
Not applicable
PIN
©2015 Iris Diagnostics
Global SDS – English
Page 21 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CB
Section 15 Regulatory Information (Continued)
Ingredients on Ingredient Disclosure List
Ethyl Alcohol
Acetone
Citric Acid
Glutaraldehyde
Sodium Nitrite
Boric Acid
Ingredients with unknown toxicological properties
Product is exempt
15.2 Chemical Safety Assessment A Chemical Safety Assessment has not been carried out.
Some hazardous ingredients listed in Section 15 are below OSHAs and WHMIS’ 1.0% w/w (0.1% for carcinogens) or EU’s ingredient specic
concentrations required for reporting in Section 3.
Section 16 Other Information
Safety Ratings
Flammability:
Health:
Reactivity with Water:
Contact:
0
3
0
3
Code
0=None
1=Slight
2=Caution
3=Severe
Updated to GHS.
Revision Changes
Hazard Class, hazard statements and risk phrase description from section 3
F - Highly ammable
T - Toxic
Repr. Cat. 2 - Toxic for Reproduction Category 2
Xi - Irritant
Xn - Harmful
R11 Highly ammable.
R36 Irritating to eyes.
R66 Repeated exposure may cause skin dryness or cracking.
R67 Vapours may cause drowsiness and dizziness.
R37/38 Irritating to respiratory system and skin.
R41 Risk of serious damage to eyes.
R42 May cause sensitization by inhalation.
R60 May impair fertility.
R61 May cause harm to unborn child.
Acute Tox. Dermal 5 - Acute Toxicity Dermal, Category 5
Acute Tox. Oral 5 - Acute Toxicity Oral, Category 5
Eye Dam. 1 - Eye Damage Category 1
Eye Irrit. 2 - Eye Irritation Category 2
Flam. Liq. 2 - Flammable Liquids, Category 2
Resp. Sens. 1 - Respiratory Sensitization Category 1
Skin Irrit. 2 - Skin Irritation Category 2
©2015 Iris Diagnostics
Global SDS – English
Page 22 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CB
Section 16 Other Information (Continued)
Abbreviations and Acronyms
Skin Irrit. 3 - Skin Irritation Category 3
STOT SE 3 - Specic Target Organ Toxicity Single Exposure Category 3
STOT SE 3 - Specic Target Organ Toxicity Single Exposure Category 3
Repr. 1B - Toxic to Reproductive Category 1B
H225 - Highly ammable liquid and vapour.
H303 - May be harmful if swallowed
H313 - May be harmful In contact with skin
H315 - Causes skin irritation.
H316 - Causes mild skin irritation.
H318 - Causes serious eye damage.
H319 - Causes serious eye irritation.
H334 - May cause allergy or asthma symptoms or breathing difculties if inhaled.
H335 - May cause respiratory irritation.
H336 - May cause drowsiness or dizziness.
H360 - May damage fertility or the unborn child.
ACGIH - American Conference of Governmental Industrial Hygienists
ADR - European Agreement Concerning The International Carriage Of Dangerous
Goods By Road
CERCLA - The Comprehensive Environmental Response, Compensation, and
Liability Act
CLP - Classication, Labeling and Packaging
DFGMAK - Republic Germany’s maximum exposure limit
GHS - Globally Harmonized System
HCS - Hazard Communication Standard
IARC - International Agency for Research on Cancer
IATA - International Air Transport Association
ICAO - International Civil Aviation Organization
IMDG - International Maritime Dangerous Goods
IOELVs - European Unions’ Indicative Occupational Exposure Limit Values
NIOSH - National Institute for Occupational Safety and Health
NTP - National Toxicology Program
OSHA - Occupational Safety and Health Administration
PBT - Persistent bioaccumulative and toxic substances
SARA - Superfund Amendments and Reauthorization Act
TDG - Canadian Transportation Of Dangerous Goods Regulations.
UN GHS - United Nations Globally Harmonized System
US DOT - United States Department of Transportation
WHMIS - Workplace Hazardous Material Information System
vPvB - Very persistent and very bioaccumulative substances
EC50 - Effective Concentration, 50%
LC50 - Lethal Concentration, 50%
©2015 Iris Diagnostics
Global SDS – English
Page 23 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CB
Section 16 Other Information (Continued)
LD50 - Lethal Dose, 50%
For further information, please contact your local Iris Diagnostics representative.
WHILE IRIS DIAGNOSTICS BELIEVES THE INFORMATION CONTAINED HEREIN IS VALID AND ACCURATE, MAKES NO WARRANTY OR REPRESENTATION AS TO ITS VALIDITY, ACCURACY, OR
CURRENCY. IRIS DIAGNOSTICS SHALL NOT BE LIABLE OR OTHERWISE RESPONSIBLE IN ANY WAY FOR USE OF EITHER THIS INFORMATION OR MATERIALS TO WHICH IT APPLIES. DISPOSAL
OF HAZARDOUS MATERIALS MAY BE SUBJECT TO LOCAL LAWS OR REGULATIONS.
©2015 Iris Diagnostics
Global SDS – English
Page 24 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
Section 1 Identication of the Substance/mixture and of the Company/undertaking
1.1
1.2
1.3
Product Identier
Product Name
IRISpec™ CC
Component of P/N 800-7211
Part Number
Relevant identied uses of the substance or mixture and uses advised against
For In Vitro Diagnostic Use. See product literature for details.
Product Use
Details of the supplier of the safety data sheet
Manufacturer
EC REP Address
IRIS International, Inc.
9172 Eton Avenue
Chatsworth, CA 91311-5874, U.S.A.
Tel: 800-776-4747
818-527-7000
[email protected]
1.4
mdi Europa GmbH
Langenhagener Str. 71
30855 Hannover-Langenhagen
Germany
+49-511-39089530
e-mail address
Emergency telephone number
Chemtrec Emergency Tel No. U.S.A. 800-424-9300, International (001)
Telephone number (24H)
703-527-3887
Distributor and Emergency Phone No.
(800) 776-4747
Section 2 Hazards Identication
2.1 Classication of substance or mixture
Product Description
Mixture
Not determined; Not determined; Liquid; Not determined
Classication according to EC 1272/2008 (CLP/GHS)
Not classied as hazardous per EC 1272/2008 (CLP/GHS)
Classication according to EC Directives 1999/45/EC and 67/548/EEC
Not classied as dangerous per EC Directives (1999/45/EC and 67/548 EEC)
Classication according to US-OSHA (HCS 29 CFR 1910.1200) and UN GHS
Toxic to Reproductive Category 1
©2015 Iris Diagnostics
Global SDS – English
Page 25 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CC
Section 2 Hazards Identication (Continued)
2.2 Label Elements
According to EC 1272/2008 (CLP/GHS), US-OSHA and UN GHS
Hazardous Ingredients
Boric Acid
Pictogram
Signal Word
DANGER
Hazard Statements
H360 May damage fertility or the unborn child.
Precautionary Statements
P201 Obtain special instructions before use.
P280 Wear protective gloves, protective clothing and eye/face protection.
P308+P313 IF exposed or concerned: Get medical advice/attention.
P405 Store locked up.
P501 Dispose of contents/container in accordance with local/national regulations
Product label will display most signicant precautionary statements.
2.3 Other hazards
Results of PBT and vPvB assessment
PBT: Not applicable.
vPvB: Not applicable.
See Section 11 Toxicological Information for more detailed health information.
Section 3 Composition and Information on Ingredients
3.2 Mixtures
Hazardous Ingredients:
Chemical Name
Calcium Chloride, Dihydrate
Hazard Classication of Pure Ingredients
% by wt.
EU-67/548/EEC
EU 1272/2008
CLP/GHS
GHS
1 - 5
Xi;R36
Eye Irrit. 2
H319
Eye Irrit. 2
H319
3, 8
0.1 - 1
T;R60-61
Repr. Cat. 2
Repr. 1B
H360
Acute Tox. Dermal
5
Acute Tox. Oral 5
Repr. 1B
Skin Irrit. 3
H303; H313; H316;
H360
SVHC
CAS # 10035-04-8
EINECS # 233-140-8
Index # Not available
Boric Acid
CAS # 10043-35-3
EINECS # 233-139-2
Index # Not available
©2015 Iris Diagnostics
Global SDS – English
Page 26 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CC
Section 3 Composition and Information on Ingredients (Continued)
3 - Health hazard
8 - Present at concentration below the cut-off limits.
SVHC - Substance of very high concern
See section 8 for available Occupational exposure limits
See Section 15 for additional regulatory information
See Section 16 for hazard class, hazard statements and risk phrase description
Section 4 First Aid Measures
4.1
Description of rst aid measures
If product is inhaled, move exposed individual to fresh air. If individual is not
Inhalation
breathing, begin articial respiration immediately and obtain medical attention.
4.2
Eye Contact
If product enters eyes, wash eyes gently under running water for 15 minutes
or longer, making sure that the eyelids are held open. If pain or irritation occur,
obtain medical attention.
Skin Contact
In case of skin contact, ush with copious amounts of water for at least 15
minutes. If pain or irritation occur, obtain medical attention.
Ingestion
If ingested, wash mouth out with water. If irritation or discomfort occurs, seek
medical attention.
Most important symptoms and effects, both acute and delayed
May damage fertility or the unborn child.
See Section 11 Toxicological Information for more detailed health information.
4.3
Indication of any immediate medical attention and special treatment needed
No further relevant information available.
Section 5 Fire Fighting Measures
Flammable Properties
Nonammable aqueous solution.
5.1
Extinguishing Media
In case of re use carbon dioxide (CO2), dry chemical, water spray or foam.
For large res use extinguishing media suitable for surrounding re.
5.2
Special hazards arising from the substance or mixture
Special Fire and Explosion Hazards
No special hazards determined.
Hazardous Combustion Products
No combustion products posing signicant hazards are expected from this
product (an aqueous solution).
5.3
5.4
Advice for re ghters
Protective Equipment
Additional information
Self-contained breathing apparatus is recommended for reghters in all
chemical re situations.
No further relevant information available.
©2015 Iris Diagnostics
Global SDS – English
Page 27 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CC
Section 6 Accidental Release Measures
6.1
Personal precautions, protective equipment and emergency procedures
Observe general safety guidelines for protection; avoid eye and skin contact.
Personal Precautions
Wear protective gloves, protective clothing and eye/face protection.
6.2
Environmental Precautions
6.3
Methods and material for containment and cleaning up
Absorb spilled material with an appropriate inert, non-ammable absorbent and
Spill and Leak Procedures
Contain spill to prevent migration.
Do not allow the undiluted product to enter sewers/surface or ground water.
dispose according to local regulations.
6.4
Reference to other sections
Refer sections 8 and 13.
Section 7 Handling and Storage
7.1
Precautions for safe handling Use good laboratory procedures; avoid eye and skin contact.
7.2
Conditions for safe storage, including any incompatibilities
Store at 2 to 8°C , as directed on the product label.
To maintain product quality, store according to the instructions in the product
labeling.
Store away from strong acids, strong bases, strong oxidizers and incompatible
materials (section 10).
7.3
Specic end uses
No further relevant information available.
Section 8 Exposure Controls and Personal Protection
8.1
Control parameters
Exposure Limits
US OSHA
None established
ACGIH
Boric Acid
CAS # 10043-35-3
6 mg/m3 STEL (inhalable fraction) (listed under Borate compounds, inorganic); 2
mg/m3 TWA (inhalable fraction) (listed under Borate compounds, inorganic)
DFG MAK
Boric Acid
CAS # 10043-35-3
10 mg/m3 Peak (as B) (inhalable fraction); 10 mg/m3 TWA MAK (inhalable
fraction) (as B)
Ireland
None established
IOELVs
None established
NIOSH
None established
Japan
None established
©2015 Iris Diagnostics
Global SDS – English
Page 28 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CC
Section 8 Exposure Controls and Personal Protection (Continued)
8.2
Exposure controls
Engineering Controls
No special engineering controls are required. Use with good general ventilation.
Eye Protection
Safety glasses or chemical goggles should be worn to prevent eye contact.
Refer U.S. OSHA 29 CFR 1910.133, European Standard EN166 or appropriate
government standards.
Skin Protection
Impervious gloves, such as Nitrile or equivalent, should be worn to prevent skin
contact.
Refer U.S. OSHA 29 CFR 1910.138, European Standard EN374 or appropriate
government standards.
Respiratory Protection
Under normal conditions, the use of this product should not require respiratory
protection. If overexposure should occur and ventilation is not adequate to
maintain airborne concentrations at acceptable levels, the use of respiratory
protection should be evaluated by a qualied professional.
Section 9 Physical and Chemical Properties
9.1
9.2
Information on basic physical and chemical properties
Physical State
Liquid
Specic Gravity
(Water=1.0)
Color
Not determined
Solubility
Transparency
Not determined
Water
Miscible
Odor
Not determined
Organic
Not determined
pH
5.0 - 6.5
Partition coefcient:
n-octanol/water
Not determined
Freezing Point
Not determined
Auto-ignition Temp.
Not applicable
Boiling Point
Not determined
Decomposition
Temperature
Not determined
Flash Point
Not applicable
Percent Volatiles
Not applicable
Evaporation Rate
Not determined
Vapor Pressure
Not determined
Flammability (Solid, Gas)
Not applicable
Viscosity
Not determined
Flammability Limits
Not applicable
Explosive Properties
Not applicable
Vapor Density
Not determined
Oxidizing Properties
Not applicable
Odor Threshold
Not applicable
Other Information
No further relevant information available.
Section 10 Stability and Reactivity
10.1 Reactivity
No further relevant information available.
©2015 Iris Diagnostics
Global SDS – English
Not determined
Page 29 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CC
Section 10 Stability and Reactivity (Continued)
10.2 Chemical Stability
The product is stable in accordance with recommended storage conditions.
10.3 Possibility of hazardous reactions
No further relevant information available.
10.4 Conditions to Avoid
To maintain product performance keep away from strong acids, strong bases,
strong oxidizers.
Avoid exposure to heat and direct sunlight.
10.5 Incompatible materials
No further relevant information available.
10.6 Hazardous Decomposition Products
No decomposition products posing signicant hazards would be expected from
this product (an aqueous solution).
Section 11 Toxicological Information
11.1 Information on toxicological effects
Toxicity Data for Hazardous Ingredients
Boric Acid
CAS # 10043-35-3
Oral LD50 Rat 2660 mg/kg; Inhalation LC50 Rat >0.16 mg/L 4 h; Dermal LD50
Rabbit >2000 mg/kg
Primary Routes of Exposure
Eye contact, ingestion, inhalation, and skin contact.
Skin Corrosion/Irritation
No data available.
Serious eye damage/eye
irritation
No data available.
Respiratory/skin sensitization No data available.
Carcinogenicity
No ingredients in this product are listed as carcinogens by ACGIH, IARC, NTP,
OSHA or 1272/2008 EC regulation.
Germ cell mutagenicity
No data available.
Reproductive Toxicity
May damage fertility or the unborn child.
Specic target organ toxicity – single exposure
No data available.
Specic target organ toxicity – repeated exposure
No data available.
Aspiration hazard
No data available.
Other Information
No further relevant information available.
©2015 Iris Diagnostics
Global SDS – English
Page 30 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CC
Section 12 Ecological Information
12.1 Ecotoxicity
No information available.
No information available.
Fresh Water Species
Microtox
Water Flea
Boric Acid
48 h EC50 Daphnia magna: 115 - 153 mg/L
CAS # 10043-35-3
No information available.
Fresh Water Algae
12.2 Persistence and degradability Not determined for the product.
12.3 Bioaccumulation
Not determined for the product.
12.4 Mobility in soil
Not determined for the product.
12.5 Results of PBT and vPvB assessment
Not determined for the product. PBT: Not applicable, vPvB: Not applicable.
12.6 Other Adverse Effects
No further relevant information available.
Section 13 Disposal Considerations
13.1 Waste treatment methods
Product Waste Disposal
13.2 Additional information
Chemical residues and remains should be routinely handled as special waste. This
must be disposed of in compliance with anti-pollution and other laws of the country
concerned. To ensure compliance we recommend that you contact the relevant
(local) authorities and/or an approved waste-disposal company for information.
Suggested European waste catalogue 18 01 07 - chemicals other than those
mentioned in 18 01 06. Dispose in accordance with national, state and local
waste regulations.
Section 14 Transport Information
Transportation of this product is not regulated under ICAO, IMDG, US DOT, European ADR or Canadian TDG.
Section 15 Regulatory Information
15.1 Safety, health and environmental regulations/legislation specic for the substance or mixture
US Federal and State Regulations
SARA 313
No ingredients listed.
California Proposition 65
No ingredients listed.
Massachusetts MSL
Glycerol is listed.
Glutaraldehyde is listed.
©2015 Iris Diagnostics
Global SDS – English
Page 31 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CC
Section 15 Regulatory Information (Continued)
New Jersey Dept. of Health RTK List
Glycerol is listed.
Glutaraldehyde is listed.
Pennsylvania RTK
Glycerol is listed.
Glutaraldehyde is listed.
EU Regulations
This SDS complies with EC Regulations 1907/2006 (REACH) and amendments.
Water Hazard Class (Germany) WGK 1, low water endangering
REACH 1907/2006 EC - Annex XIV - list of substances subject to authorization.
No ingredients listed.
According to EC Directives (1999/45/EC and 67/548 EEC)
Not classied as dangerous per EC Directives (1999/45/EC and 67/548 EEC)
Canada
This product is exempt from WHMIS label and SDS requirements.
Not applicable
PIN
Ingredients on Ingredient Disclosure List
Citric Acid
Glutaraldehyde
Boric Acid
Ingredients with unknown toxicological properties
Product is exempt
15.2 Chemical Safety Assessment A Chemical Safety Assessment has not been carried out.
Some hazardous ingredients listed in Section 15 are below OSHAs and WHMIS’ 1.0% w/w (0.1% for carcinogens) or EU’s ingredient specic
concentrations required for reporting in Section 3.
Section 16 Other Information
Safety Ratings
Flammability:
Health:
Reactivity with Water:
Contact:
0
3
0
3
Code
0=None
1=Slight
2=Caution
3=Severe
Updated to GHS.
Revision Changes
Hazard Class, hazard statements and risk phrase description from section 3
T - Toxic
Repr. Cat. 2 - Toxic for Reproduction Category 2
Xi - Irritant
R36 Irritating to eyes.
R60 May impair fertility.
R61 May cause harm to unborn child.
Acute Tox. Dermal 5 - Acute Toxicity Dermal, Category 5
©2015 Iris Diagnostics
Global SDS – English
Page 32 of 32
SAFETY DATA SHEET
Doc. ID: 300-7625 Rev. AC
. Revised (year/month/day) 2015/03/30
IRISpec™ CA/CB/CC SET NA
IRISpec™ CC
Section 16 Other Information (Continued)
Abbreviations and Acronyms
Acute Tox. Oral 5 - Acute Toxicity Oral, Category 5
Eye Irrit. 2 - Eye Irritation Category 2
Skin Irrit. 3 - Skin Irritation Category 3
Repr. 1B - Toxic to Reproductive Category 1B
H303 - May be harmful if swallowed
H313 - May be harmful In contact with skin
H316 - Causes mild skin irritation.
H319 - Causes serious eye irritation.
H360 - May damage fertility or the unborn child.
ACGIH - American Conference of Governmental Industrial Hygienists
ADR - European Agreement Concerning The International Carriage Of Dangerous
Goods By Road
CERCLA - The Comprehensive Environmental Response, Compensation, and
Liability Act
CLP - Classication, Labeling and Packaging
DFGMAK - Republic Germany’s maximum exposure limit
GHS - Globally Harmonized System
HCS - Hazard Communication Standard
IARC - International Agency for Research on Cancer
IATA - International Air Transport Association
ICAO - International Civil Aviation Organization
IMDG - International Maritime Dangerous Goods
IOELVs - European Unions’ Indicative Occupational Exposure Limit Values
NIOSH - National Institute for Occupational Safety and Health
NTP - National Toxicology Program
OSHA - Occupational Safety and Health Administration
PBT - Persistent bioaccumulative and toxic substances
SARA - Superfund Amendments and Reauthorization Act
TDG - Canadian Transportation Of Dangerous Goods Regulations.
UN GHS - United Nations Globally Harmonized System
US DOT - United States Department of Transportation
WHMIS - Workplace Hazardous Material Information System
vPvB - Very persistent and very bioaccumulative substances
EC50 - Effective Concentration, 50%
LC50 - Lethal Concentration, 50%
LD50 - Lethal Dose, 50%
For further information, please contact your local Iris Diagnostics representative.
WHILE IRIS DIAGNOSTICS BELIEVES THE INFORMATION CONTAINED HEREIN IS VALID AND ACCURATE, MAKES NO WARRANTY OR REPRESENTATION AS TO ITS VALIDITY, ACCURACY, OR
CURRENCY. IRIS DIAGNOSTICS SHALL NOT BE LIABLE OR OTHERWISE RESPONSIBLE IN ANY WAY FOR USE OF EITHER THIS INFORMATION OR MATERIALS TO WHICH IT APPLIES. DISPOSAL
OF HAZARDOUS MATERIALS MAY BE SUBJECT TO LOCAL LAWS OR REGULATIONS.
©2015 Iris Diagnostics
Global SDS – English