Registration Dossier
Registration Dossier
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EC number: 429-040-0 | CAS number: 272460-97-6
Endpoint summary
Administrative data
Description of key information
Study conducted to recognised testing guidelines with GLP certification.
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:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- other: Not specified - from "429-04-0_endpoints_PV512082-22" provided by ECHA
- Justification for non-LLNA method:
- From "429-04-0_endpoints_PV512082-22" provided by ECHA
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Route:
- intradermal
- Vehicle:
- other: at 2.5% in cottonseed oil and in FCA.
- Concentration / amount:
- 0.1 mL/injection site of test material
- Route:
- intradermal
- Concentration / amount:
- In booster. 0.3 mL/patch of test material at 25% in acetone.
Concentration of test material and vehicle used for each challenge:
0.2 mL/patch of test material at 25% in acetone - No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 20 - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
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.
