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EC number: 287-619-1 | CAS number: 85563-48-0
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic information given
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- according to Magnusson and Kligman (J. Invest. Dermatol. 52, 1969); recommended in the OECD guidelines 1981 and in the EEC Directive 79/831
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was done before implementation of the LLNA method.
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- - Acclimatization period: 12 days
- Age at study start: about 10 weeks
- Body weights between 292 and 480 g
- The animals were housed individually in Macrolon cages (type 3), assigned to the different groups by means of random numbers generated by the random number generator incorporated in the Hewlett-Packard desk computer, identified with individual ear tags, kept at a constant room ternperature of 20 +/- 1°C, at a relative humidity of 50 +/- 10% and on a 14 hours light cycle day. A 14 hours light cycle day is necessary to eliminate seasonal variation because the animal rooms are not totally protected from natural sunlight.
- The animals received ad libitum standard guinea-pigs pellets and fresh water, supplemented with fresh carrots. - Route:
- other: intradermal and epidermal
- Vehicle:
- other: induction: physiological saline; challenge: soft white petrolatum (vaseline)
- Concentration / amount:
- - Induction: intradermal 5% test substance, epidermal 10% test substance
- Challenge: epidermal 1% test substance - Route:
- other: epidermal
- Vehicle:
- other: induction: physiological saline; challenge: soft white petrolatum (vaseline)
- Concentration / amount:
- - Induction: intradermal 5% test substance, epidermal 10% test substance
- Challenge: epidermal 1% test substance - No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- - Induction, intradermal application: Two intraderrnal injections (0.1 ml per injection) were made into the neck of the guinea-pigs with a mixture of adjuvant and saline, with the test compound in saline and with the test compound in the adjuvant saline mixture.
- Induction, epiderinal application: One week later the test compound was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (occlusive administration for 48 hours).
- Challenge: Two weeks after the epidermal induction application the animals were tested on the flank with 1% test compound in vaseline and the vehicle alone (24 h occlusive application). Twenty-four hours after removing the dressings the challenge reactions were graded according to the Draize scoring scale. The application sites were chemically depilated 3 hours before examination. A second evaluation is made 48 hours after removing the dressings. The concentrations of the test compound for induction and challenge periods were determined on separate animals. A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals. - Positive control substance(s):
- yes
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 and 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 and 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 and 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 and 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to these test results the test item can be classified as "no skin sensitizer" in the GPMT on guinea pigs.
- Executive summary:
The skin sensitising potential of the test item was asessed using the guinea pig maximisation test. The test was performed with 10 male and 10 females guinea pigs per group. For the induction two intradermal injections (0.1ml) were done and one week later the epidermal induction was done by an occlusive application of the test substance diluted in vaseline for 48 hours. Two weeks after the epidermal induction the challenge was done with an application on the flank wit 1% in vaseline ( 24 h occlusive dressing). Twenty-four hours after removal of the patch, the reactions were graded according to the Draize scoring scale. A second evaluation is made 48 hours after removal. A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound. None of the animals showed any signs of skin irritation or skin sensitisation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising potential of the test item was asessed using the guinea pig maximisation test. The test was performed with 10 male and 10 females guinea pigs per group. For the induction two intradermal injections (0.1ml) were done and one week later the epidermal induction was done by an occlusive application of the test substance diluted in vaseline for 48 hours. Two weeks after the epidermal induction the challenge was done with an application on the flank wit 1% in vaseline ( 24 h occlusive dressing). Twenty-four hours after removal of the patch, the reactions were graded according to the Draize scoring scale. A second evaluation is made 48 hours after removal. A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound. None of the animals showed any signs of skin irritation or skin sensitisation.
The information available on the skin sensitisation potential of the test item show no need for a classification of the test item concerning skin sensitisation.
Migrated from Short description of key information:
GPMT: not sensitising
Justification for selection of skin sensitisation endpoint:
Reliable and well documented study which is the basis for classification.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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 for skin sensitisation under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the fifth time in Directive EC 944/2013.
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