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EC number: 267-032-7 | CAS number: 67762-73-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
An acute toxicity study by dermal route was performed on the registered substance, which showed no skin corrosion and a slight irritation after a 24-hour exposure. Therefore, it was not considered justified to perform an in vitro skin corrosion study.
The skin irritation study was conducted on the registered substance according to OECD Testing Guideline 439 and gave a relative mean tissue viability calculated as a percentage of the negative control of 110.9 % after the 15-minute exposure followed by the 42-hour post-exposure. The registered substance is not classified as a skin irritant according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
The eye irritation study was conducted on the registered substance according to a method similar to OECD Testing Guideline 405 and induced a slight redness in all animals, fully reversible within 24 hours for 4/6 animals. The registered substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 17 February 2016 to 22 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E00350-290
- Expiration date of the lot/batch: 23 June 2019
- Purity test date: 58 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark - Test system:
- human skin model
- Remarks:
- EPISKIN reconstructed human epidermis
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EPISKINTM Reconstructed Human Epidermis Model Kit
Supplier: SkinEthic Laboratories, Lyon, France
Date received: 16 February 2016
EpiSkinTM Tissues (0.38cm²) lot number: 16-EKIN-007
Maintenance Medium lot number: 16-MAIN3-009
Assay Medium lot number: 16-ESSC-007 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL (26.3 µL/cm²)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL Dulbecco’s Phosphate Buffered Saline with Ca++ and Mg++
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL Sodium Dodecyl Sulphate
- Concentration (if solution): 5 % w/v aqueous solution - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- Triplicate
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Relative mean
- Value:
- 110.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 113
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 106.4
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 113.3
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: The MTT solution containing the test item did not turn blue which indicated that the test item did not directly reduce MTT.
- Colour interference with MTT: The solution containing the test item was colourless, it was therefore unnecessary to run color correction tissues.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: YES
- Acceptance criteria met for positive control: YES
- Acceptance criteria met for variability between replicate measurements: YES - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The relative mean tissue viability calculated as a percentage of the negative control was 110.9 % after the 15-minute exposure followed by the 42-hour post exposure. The test substance did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
- Executive summary:
The in vitro skin irritation of the test substance was determined in accordance with the OECD Testing Guideline 439. The purpose of this test was to evaluate the skin irritation potential of the registered substance using the EPISKINTM reconstructed human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in reconstructed human epidermal cultures following topical exposure to the test item by means of the colorimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the registered substance treated tissues relative to the negative controls.
Triplicate tissues were treated with the registered substance for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labeled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT-loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues. At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre-labeled 96-well plate. The optical density was measured at 562 nm. Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
The relative mean tissue viability calculated as a percentage of the negative control was 110.9 % after the 15-minute exposure followed by the 42-hour post-exposure. The test substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Reference
Mean OD562 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item | OD562 of tissues | Mean OD562 of triplicate tissues | ±SD of OD562 | Relative individual tissue viability (%) | Relative mean viability (%) | ±SD of relative mean viability |
Negative Control Item | 0.865 | 0.845 | 0.024 | 102.3 | 100* | 2.8 |
0.819 | 96.9 | |||||
0.852 | 100.8 | |||||
Positive Control Item | 0.063 | 0.071 | 0.012 | 7.5 | 8.4 | 1.3 |
0.065 | 7.7 | |||||
0.084 | 9.9 | |||||
Test Item | 0.955 | 0.937 | 0.033 | 113.0 | 110.9 | 3.9 |
0.899 | 106.4 | |||||
0.957 | 113.3 |
*=The mean viability of the negative control tissue is set at 100%
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- missing data on animals
- Principles of method if other than guideline:
- Study was conducted using a method equivalent to OECD Testing Guideline 405 and meets acceptable scientific standards. 0.1mL of the registered substance was instilled in the left eye of six New Zealand White, which were therefore observed for seven days, as all observable adverse effects had disappeared by this time. Observations were recorded and scored according to Draize, which is the scoring system used by EU and OECD methods. As a result, it is considered that the study is providing a sufficient amount of data in order to conclude regarding the eye irritation of the registered substance.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.6 - 3.1 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Treated eye held closed for one second following application
- Observation period (in vivo):
- 7 days (it was not considered relevant to pursue the observation as all effects had reversed).
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: According to J.H. Draize
TOOL USED TO ASSESS SCORE: 2.0 % sodium fluorescein stain - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Max score of 1 reported at 1 and 4 hours observation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Max score of 1 reported at 1 and 4 hours observation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Max score of 1 reported at 1 and 4 hours observation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Max score of 1 reported at 1 and 4 hours observation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Slight redness observed at 1 hour and 4 hours in all animals and at 24 hours in two animals. Slight discharge appeared in all animals at one hour only. All effects were fully reversible in all animals and fluorescein staining at seven days confirmed the absence of corneal damage in all eyes.
- Other effects:
- Blinking in all animals after treatment.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance induced a slight redness in all animals, fully reversible within 24 hours for 4/6 animals and 48 hours for 6/6 animals. The test substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
- Executive summary:
The test substance was analysed for eye irritation on New Zealand white rabbit eyes using a method similar to OECD Guideline 405. The left eye of the animals was exposed to 0.1 mL of the test substance whilst the right eye was left as a control. Fluorecein staining at seven days showed no corneal damage in any of the test subjects. Slight redness was observed in all animals after exposure but did not last more than a day. All animals also showed slight discharge at one hour only. All effects were reversible within 24 hours for 4/6 animals and 48 hours for the remaining animals. The test substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
See attached background information.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation potential of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 439. The purpose of this test was to evaluate the skin irritation potential of the test item using the EPISKINTM reconstructed human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in reconstructed human epidermal cultures following topical exposure to the test item by means of the colorimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test item treated tissues relative to the negative controls. The Relative mean tissue viability calculated as a percentage of the negative control was 110.9 % after the 15-minute exposure followed by the 42-hour post-exposure.
The eye irritation potential of the registered substance was determined in accordance with a method similar to OECD Guideline for Testing of Chemicals 405 with deviation. The left eye of six New Zealand White rabbits were exposed to 0.1 mL of the test substance whilst the right eye was left untreated and used as a control. Fluorecein staining at seven days showed no corneal damage in any of the test subjects. A slight redness at 1 hour and 4 hours in all animals and at 24 hours in two animals. Slight discharge appeared in all animals at one hour only. The observed effects were fully reversible.
Justification for selection of skin irritation / corrosion
endpoint:
Study was conducted on the registered substance according to OECD
Testing Guideline 439. According to the Guidance on Information
Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint
specific guidance (Version 4.0), reconstructed human epidermis (RHE)
tests are considered scientifically valid for the prediction of irritant
(Category 2) and non-irritant (no category) substances in accordance
with the rules laid down in Annex XI, and therefore additional in vivo
testing is not considered as scientifically justified.
Justification for selection of eye irritation endpoint:
Study was conducted using a method equivalent to OECD Testing
Guideline 405 and meets acceptable scientific standards and the study
was conducted on the registered substance.
Justification for classification or non-classification
The skin irritation study was conducted on the registered substance according to OECD Testing Guideline 439 and gave a relative mean tissue viability calculated as a percentage of the negative control of 110.9 % after the 15-minute exposure followed by the 42-hour post-exposure. The test substance is not classified as a skin irritant according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
The eye irritation study was conducted on the registered substance according to a method similar to OECD Testing Guideline 405 and induced a slight redness in all animals, fully reversible within 24 hours for
4/6 animals. The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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