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EC number: 603-491-5 | CAS number: 131513-00-3
- 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
Skin: Under the test conditions chosen the test substance does not give indication of an irritant property to the skin.
Eye: Under the test conditions chosen the test substance does not give indication of an irritant property to the 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 and guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; D-W6050 Offenbach, Germany
- Age at study initiation: young adult animals
- Sex: male
- Weight at study initiation: 2.93, 2.86, 3.12 kg
- Housing: single housing in cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet: KLIBA Labordiät 341; Klingentalmühle AG, CH-4303 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
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0,5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 * 2.5 cm
- Type of wrap if used: The test patch was secured in position with a semiocclusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed at the end of the exposure period with Lutrol(R) (Lutrol (R) E 400= Polyethylenglycol DAB, BASF AG) and Lutrol(R)/ water (1 : 1).
- Time after start of exposure: 4 h exposure period
SCORING SYSTEM: according to OECD Guideline 404 (adopted May 12, 1981) and EEC L 251, B.4. (Sept. 19, 1984) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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 and guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: GAUKLER; D-6050 Offenbach /Main, Germany
- Age at study initiation: young adult animals,
-Sex: males
- Weight at study initiation: 2.74 kg, 3.17 kg, 3.04 kg
- Housing: single housing in steel cage with wire mesh walk floors, floor area 40 cm * 51 cm
- Diet: about 130 g KLiba - Labordiät 341 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
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
According to OECD guideline 405 and EU method B5 - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 h , 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin:
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 irritation was calculated to be 0.0 for erythema and 0.0 for edema. As no skin reaction was observed, the study was terminated after 72 hours. 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:
The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in 3 White Vienna rabbits, subjected to a single ocular application of about 0.1 mL of the test substance on day 0.
The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, 0.1 for iris, 1.2 for conjunctivae redness and 0.6 for chemosis. The findings were reversible in all animals within 8 days, thus the study was terminated after 8 days. For all animals the mean cornea score over the time points 24 h, 48 h and 72 h was 0, the mean iris score for animal 1 was 0.33, for animal 2 and 3 it was 0. The mean conjunctivae scores were 2 (animal 1), 0.33 (animal 2) and 1.33 (animal 3). The mean chemosis scores were 1.33 (animal 1), 0 (animal 2) and 0.33 (animal 3).
Under the test conditions chosen and considering the described findings the test substance does not give indication of an irritant property to the eye.
Justification for selection of skin irritation / corrosion endpoint:
GLP conform guideline study
Justification for selection of eye irritation endpoint:
GLP conform guideline study
Justification for classification or non-classification
The test substance was not irritating to the skin and eye in vivo.
Dangerous
Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for
classification purposes under 67/548/EEC. As a result the substance is
not considered to be classified under Directive 67/548/EEC, as amended
for the 31st time in Directive 2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. As a result
the substance is not considered to be classified under Regulation (EC)
No 1272/2008, as amended for the sixth time in Regulation No 605/2014.
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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