Registration Dossier
Registration Dossier
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EC number: 460-360-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- 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
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Ref : 13L508D
In vivo test system
Test animals
- Species:
- human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- ranging in age from 22 to 69 years
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 160 µl/patch (dilution : 10%)
Challengeopen allclose all
- 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.
Results and discussion
- 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
In vivo (non-LLNA)
Resultsopen allclose all
- 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
Any other information on results incl. tables
The test item can be considered as non sensitizer
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item can be considered as non sensitizer
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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