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Diss Factsheets
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EC number: 264-935-8 | CAS number: 64519-44-4
- 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
In a Guinea pig skin sensitization test the test item was found to be not a skin sensitizer.
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:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not applicable
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Exisitng in vivo study available (1974)
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Route:
- intradermal
- Vehicle:
- other: 6% acetone/saline
- Concentration / amount:
- 0.1875%
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- other: 6%acetone/ saline
- Concentration / amount:
- 0.075%
- No.:
- #2
- Route:
- other: topical
- Vehicle:
- other: acetone
- Concentration / amount:
- 20%
- No. of animals per dose:
- 10
- Details on study design:
- Guinea pigs were treated to induce sensitization by intradermal injection, and were challenged approximately 2 weeks later by intradermal injection and topical application. As there was no evidence of sensitization the induction and challenge sequences were repeated.
- Challenge controls:
- no data
- Positive control substance(s):
- no
- Positive control results:
- no data
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- induction 0.1875%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Group:
- test chemical
- Dose level:
- intradermal injection 0.075%/ topical application 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- rechallenge
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- rechallenge
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No guinea pigs sensitized after 1 or 2 induction-treatments.
- Executive summary:
A Guinea pig skin sensitization test was conducted with the test item.
10 Guinea pigs were treated to induce sensitization by intradermal injection, and were challenged approximately 2 weeks later by intradermal injection and topical application. As there was no evidence of sensitization the induction and challenge sequences were repeated.
After 2 sets of sensitizing injections no guinea pigs were sensitized.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
A Guinea pig skin sensitization test was conducted with the test item.
10 Guinea pigs were treated to induce sensitization by intradermal injection, and were challenged approximately 2 weeks later by intradermal injection and topical application. As there was no evidence of sensitization the induction and challenge sequences were repeated.
After 2 sets of sensitizing injections no guinea pigs were sensitized.
Justification for classification or non-classification
Harmonized classification:
The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the available data, the registered substance is not classified for skin sensitisation according to the Regulation (EC) No. 1272/2008 (CLP) and GHS.
No information was available regarding respiratory sensitisation.
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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