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EC number: 942-381-4 | 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, GLP) and eye irritation (OECD 405, GLP) 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 adults
- Weight at study initiation: 3.26 - 3.66 kg
- Housing: single housing, stainless steel wire mesh cages with grating, floor area 3000 cm2; no bedding in the cages, sawdust in the waste trays
- Diet: 130 g/day, Kliba-Labordiaet 341, Klingentalmuehle AG Kaiseraugst, Switzerland
- Water: 250 mL/day tap water
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: central air-conditioning
- Photoperiod (hrs dark / hrs light): 12/12 - 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 a dose of 0.5 mL of the undiluted liquid test substance.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm, upper third of the back or flanks
- Type of wrap if used: test patch (idealbinde, pfaelzische verbandstoff-fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing: lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 h
SCORING SYSTEM: erythema and eschar formation, and edema formation according to OECD 404 guideline 1, 24, 48, and 72 hours after removal of the patch.
General observations: A check was made twice each workday and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the test the substance is considered to be not corrosive or irritating to the skin.
- Executive summary:
The potential to cause acute dermal irritation or corrosion was assessed in a OECD 404 guideline study (in compliance with GLP) 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 irritation was calculated to be 0.1 for erythema and 0.0 for edema. The findings were reversible between 24 and 48 hours after removal of the patches. It was concluded that the test substance was not irritating 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 adults
- Weight at study initiation: 3.66 - 3.85 kg
- Housing: single housing, in stainless steel wire mesh cages with grating, floor area 3000 cm2; no bedding in the cages, sawdust in the waste trays
- Diet: 130 g/day of Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water: 250 mL tap water/day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 -70
- Air: central air-conditioning
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 mL to the conjunctival sac of the right eyelid
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Both eyes were examined before application of the test substance for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used in the study.
- Weight determination: shortly before application of the test substance
- The test substance was not washed out.
- Readings: 1, 24, 48 and 72 h after application
- A check for general observation and mortality was made twice each working day and once on weekends and on public holidays.
- SCORING SYSTEM: Cornea, conjunctivae, chemosis and iris effects as stated in the OECD 405 guideline - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the test the substance is considered to be not corrosive or 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) in 3 white Vienna rabbits subjected to a single ocular application of 0.1 mL of the test substance on day 0. The average score (24 to 72 hours) for irritation was calculated to be 0 for corneal opacity, iris, chemosis, and 0.9 for conjunctivae redness (in which two animals had a score of 1 and one a score of 0.7). The findings were reversible withing 72 hours after application. It was concluded that the test substance was 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 / corrosion
The potential to cause acute dermal irritation or corrosion was assessed in a OECD 404 guideline study (in compliance with GLP) 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 irritation was calculated to be 0.1 for erythema and 0.0 for edema. The findings were reversible between 24 and 48 hours after removal of the patches. It was concluded that the test substance was not irritating 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) in 3 white Vienna rabbits subjected to a single ocular application of 0.1 mL of the test substance on day 0 (BASF 1994). The average score (24 to 72 hours) for irritation was calculated to be 0 for corneal opacity, iris, chemosis, and 0.9 for conjunctivae redness (in which two animals had a score of 1 and one a score of 0.7). The findings were reversible withing 72 hours after application. It was concluded that the test substance was 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 observed in the skin and eye irritation and corrosion tests, 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.
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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