Registration Dossier
Registration Dossier
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EC number: 460-360-3 | CAS number: -
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:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: Method of Marzulli-Maibach
- GLP compliance:
- yes
- Type of study:
- patch test
- Justification for non-LLNA method:
- LLNA method was not realized because another test was available
- Species:
- human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- ranging in age from 22 to 69 years
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 160 µl/patch (dilution : 10%)
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 160 µl/patch (dilution : 10%)
- No. of animals per dose:
- 109
- Details on study design:
- induction phase : 160 µl of test item covered the surface of the patch and was removed each wednesday, friday and monday then the site was scored by the investigator 20 minutes after patch removal. Dermal responses for this phase were scored.
Challenge phase : after a rest period of 2 weeks (no application of the test article), the challenge patch was applied to a previously unpatched and patched test site. The site was scored 20 minutes, 24 and 48 hours after removal. - Positive control results:
- During the induction phase : there were no responses to any subject
During the challenge phase : there were no responses to any subject - Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 160µl
- No. with + reactions:
- 0
- Total no. in group:
- 109
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 160µl
- No. with + reactions:
- 0
- Total no. in group:
- 109
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item can be considered as non sensitizer
Reference
The test item can be considered as non sensitizer
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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.
