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Diss Factsheets
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EC number: 429-580-7 | 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
The read-across substance showed no skin sensitisation potential in a GPMT (reference 7.4.1 -1).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to section 13 for the read-across justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no signs of toxicity
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no signs of toxicity
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of toxicity
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10 g/L
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 10 g/L
- No. with + reactions:
- 4
- Total no. in group:
- 10
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No study data with the test item is available for skin sensitisation. Therefore, a read-across to the read-across substance with a very similar chemical structure and comparable physico-chemical parameters is used to evaluate the skin sensitisation potential of the test item.
An in vivo study in guinea pigs according to OECD 406 was conducted to evaluate the skin sensitsation potential of the read-across substance. 10 females were treated with the vehicles liquid paraffin (group 1) and 20 females were treated with the read-across substance (group 2). The induction included intradermal injection of read-across substance preparation in liquid paraffin (5 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of read-across substance preparation in liquid paraffin (50 g/L) for 48 hours on experimental day 8. The challenge was performed by topical application of the read-across substance preparation (10 g/L) for 24 hours, two weeks after topical induction and readings were taken at 48 hours and 72 hours after start of treatment. After challenge no positive reactions were seen 48 or 72 hours after treatment with the read-across substance. Based on the study results the read-across substance showed no skin sensitization potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data for skin sensitization is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is considered to be not classified for skin sensitisation (UN GHS: No category) under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EC) 2019/521.
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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