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Diss Factsheets
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EC number: 210-848-5 | CAS number: 624-48-6
- 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
Skin irritation/corrosion: Ullmann 1985. Primary Skin Irritation Rabbits, OECD404: no classification
Eye irritation: Suberg 1985. Eye irritation, OECD405: slightly irritating
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:
- weight of evidence
- Study period:
- 8 March 1985 to 3 April 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, publication/study report which meets basic scientific principles, but details missing
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 1, 24, 48 and 72 hours after removal of dressing
- Number of animals:
- 6 (3 per sex)
- Details on study design:
- TEST SITE
- Area of exposure: 3 x 3 cm
- Type of wrap if used: occlusive dressing
SCORING SYSTEM: according to OECD guideline 404 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0.3
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0.3
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was found to cause erythema or edema (very slight to moderate) 1 hr after removal of the patch. At 24 hrs only very slight reactions were observed in 2 animals and no effects occurred 72 hrs p.a. No classification was derived from the results of this study.
- Executive summary:
The test substance was applied to the intact skin of 6 rabbits. The duration of exposure was 4 hours. Occlusive dressings were used. Readings were made 1, 24, 48 and 72 hours after exposure.
The test substance was found to cause erythema or edema (very slight to moderate) 1 hr after removal of the patch. At 24 hrs only very slight reactions were observed in 2 animals and no effects occurred 72 hrs p.a.
No classification was derived from the results of this study.
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:
- weight of evidence
- Study period:
- 1985
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Remarks on result:
- other: No individual data are available.
- Irritant / corrosive response data:
- The substance is described as slightly irritating.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- The test item was slightly irritating to the eyes of rabbits.
- Executive summary:
A test was performed according to the OECD-method. The test item was slightly irritating to the eyes of rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion: Seven studies are available. The results of the studies range in most cases between not irritant and strong irritant, by using different methods. Only 1 study, that of Shapiro 1979, found the substance to be corrosive to the skin. This study and the classification criteria used are not compatible with the OECD-method or EU-classification.
The selected key study is the most recent study, it was performed according to the OECD-method and GLP and was performed to clarify the different results reported earlier.
Eye irritation: Four studies are available. Only one study, the most recent one of Suberg 1985, was performed according to the OECD-method. The other 3 studies give an indication that an eye irritation will occur, when the substance is applied to the eye, but they are not useful for classification purposes.
Justification for selection of skin irritation / corrosion endpoint:
The most recent study according to the OECD-method and GLP is selected. It was performed to clarify the different results ranging from no irritation to corrosion reported previously.
Justification for selection of eye irritation endpoint:
The most recent study and the only one performed according to the OECD-method is selected.
Effects on eye irritation: irritating
Justification for classification or non-classification
Skin irritation/corrosion: No relevant skin irritation was detected in the selected key study.
Eye irritation: Irritations were observed in each of the studies. The key study reports "slight irritation".
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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