Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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
No data on skin sensitising properties on the substance itself are available. Therefore studies from structurally related substances are given.
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 based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Please refer to chapter 13 for the category justification.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- other: after intradermal challenge injection
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Read-across from CAS# 8013-07-8
- Reading:
- other: after occlusive epicutanous application
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Read-across from CAS# 8013-07-8
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No information is available for the substance itself, therefore information is derived from the structural analogue CAS# 158318-67-3, CAS# 8013-07-8 and CAS# 61789-01-3, for which data from guinea pig maximisation test, Buehler assays are available.
Buehler test
A GLP guideline study according to OECD TG 406 was performed with Pirbright White guinea pigs (10 animals per dose group) to assess the skin sensitising potential of the test substance (Henkel, 1993). After a weekly epidermal induction (0.5 mL of a 25% test substance solution), which was performed thrice, a epidermal challenge procedure was performed with 10% test substance solution, which was supposed to be a non-irritating concentration regarding the results obtained from the dose finding study, which was performed prior to the main study. While 10/10 animals of the negative control group showed a slight reaction, 8/10 animals of the test group showed a slight reaction after 24 h of the challenge procedure. These findings were also present after 48 h, when 10/10 control animals and 5/10 test animals still showed a slight reaction to the challenge. Because of the high number of positive responses in the control group, the data are judged to be inconclusive and insufficient for classification purposes (Henkel 1993).
Guinea pig maximisation test (CAS# 8013-07-8)
The contact sensitizing potential of the test item was assessed in vivo using an guinea pig maximisation test. The study was performed according to the optimization test by Maurer et al (1975, 1980) (similar to OECD 406, no GLP). The test was performed on groups of 10 male and 10 female guinea pigs of the Pirbright White Strain. The animals were treated with 0.1ml of 0.1% solution of the test substance. Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen. After either intradermal or epidermal challenge application of the test substance.
The test substance was found to be devoid of skin-sensitising (contact allergenic) potential in albino guinea pigs.
CAS# 61789 -01 -3
Sensitization of 20 male albino guinea pigs was evaluated by 8 intracutaneous injections (three per week on alternate days) and topical applications of a 0.1% solution of the test substance during 2 1/2 weeks.
A three-week incubation period was followed by a challenge dose. 24 and 48 hours later the examination for possible sensitization reactions was made.
The animals showed no sensitization upon the test material.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No effects were observed in the skin sensitization tests. Therefore, the substance does not require classification as a skin sensitizer under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.