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EC number: 942-324-3 | CAS number: -
- 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
Based on skin (OECD 404) and eye irritation (OECD 405) studies performed in vivo, it can be concluded that the test substance is not corrosive or irritating to the skin and eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; Offenbach / Main, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: male animal: 2.8 kg; female animals: 2.99 kg and 2.74 kg
- Housing: One animal per cage (type: stainless steel wire mesh cages with grating, floor area: 3000 cm2)
- Diet: Kliba-labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: tap water (about 250 mL/animal/day)
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- The test patches (2.5 x 2.5 cm) were moistened with 0.5 mL of the undiluted test substance.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- At least 24 hours before study start, the fur was removed by clipping the dorsal of the trunk of the animals; only animals with healthy intact skin have been used. The test substance was applied in a single dose to the intact untreated skin.
- Application site: upper third of the back or flanks
- Readings: 1 h, 24 h, 48 h and 72 h after removal of the test patches
- A check for general observations and mortality was made twice each working day and once on weekends and on public holidays
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hour - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal: #2 and #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, and #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Based on the results obtained in this study and under the test conditions the test substance is not irritating to the skin.
- Executive summary:
The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of 3 white Vienna rabbits for 4 hours under semiocclusive dressing. The average score (24 to 72 hours) for erythema was calculated to be 0.7, 0, and 0 for the three animals, respectively. The score for edema was 0 for all animals. The erythema observed in one animal was reversible within 72 hours after removal of the patch. Under the test conditions chosen and considering the described findings the test substnace does not give indication of an irritant property to the skin.
Reference
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; Offenbach / Main, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: mean body weight: 3.18 kg
- Housing: Single housing stainless steel wire mesh cages with grating, floor area : 3000 cm2
- Diet: Kliba-labordiaet 343, Klingentalmuehle AG Kaiseraugst, Switzerland. About 130 g per animal per day
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Photoperiod: 12 h light and 12 h dark - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Substance was not washed out.
- Observation period (in vivo):
- 15 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Readings: 1 h, 24 h, 48 h, 72 h, 8 d and 14 day after instillation
- A check for general observations and mortality was made twice each working day and once on weekends and on public holidays. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, and #3
- Time point:
- other: mean 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, and #3
- Time point:
- other: mean 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24-48-72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean 24-48-72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean 24-48-72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean 24-48-72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- One female animal showed a contracted pupil at 1 hour after exposure
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the concitions of the performed eye irritation study, the test substance was determined to be not irritating to the eye.
- Executive summary:
The potential to cause damage to the conjunctiva, iris or cornea was assessed in an OECD 405 guideline study in compliance with GLP. Three white Vienna rabbits were subjected to a single ocular application of 0.1 mL of the test substance on day 0. The mean score (24 to 72 hours) for irritation was calculated to be 0 (all animals) for corneal opacity and iritis, 0, 1, and 0.3 for chemosis and 0.3, 2, and 1 for conjunctivae redness for animal 1, 2, and 3 respectively. The eye findings observed were reversible in one animal within 48 hours; another animal was free of signs 72 hours after instillation and in the 3rd animal the eye findings were reversible within 15 days after instillation. Based on these findings it is concluded that the test substance is not irritating to the eye
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of 3 white Vienna rabbits for 4 hours under semiocclusive dressing (BASF 1994). The average score (24 to 72 hours) for erythema was calculated to be 0.7, 0, and 0 for the three animals, respectively. The score for edema was 0 for all animals. The erythema observed in one animal was reversible within 72 hours after removal of the patch. Under the test conditions chosen and considering the described findings the test substance does not give indication of an irritant property to the skin.
Eye irritation:
The potential to cause damage to the conjunctiva, iris or cornea was assessed in an OECD 405 guideline study in compliance with GLP (BASF 1994). Three white Vienna rabbits were subjected to a single ocular application of 0.1 mL of the test substance on day 0. The mean score (24 to 72 hours) for irritation was calculated to be 0 (all animals) for corneal opacity and iritis, 0, 1, and 0.3 for chemosis and 0.3, 2, and 1 for conjunctivae redness for animal 1, 2, and 3 respectively. The eye findings observed were reversible in one animal within 48 hours; another animal was free of signs 72 hours after instillation and in the 3rd animal the eye findings were reversible within 15 days after instillation. Based on these findings it is concluded that the test substance is not irritating to the eye.
Justification for selection of skin irritation / corrosion endpoint:
One skin irritation / corrosion study is available. This study is adequate for covering this endpoint.
Justification for selection of eye irritation endpoint:
One eye irritation study is available. This study is adequate for covering this endpoint.
Justification for classification or non-classification
Based on the results obtained in the skin irritation test (according to OECD guideline 404) and the eye irritation test (according to OECD guideline 405) showing very limited effects, classification for skin irritation / corrosion and eye irritation is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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