Registration Dossier
Registration Dossier
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EC number: 285-503-5 | CAS number: 85114-00-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- In vivo study conducted in 2012 before the mandatory requirement for in vitro skin sensitisation test data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 100, 50 and 25% v/v
- No. of animals per dose:
- 4 females
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- SI = 5.76, Positive
- Parameter:
- SI
- Remarks on result:
- other: 25% = 1.48 50% = 1.92 100% = 0.94
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 25% = 23114.85 50% = 29906.12 100% = 14639.73
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not a skin sensitiser
Reference
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The substance gave a negative response in a reliable LLNA.
Migrated from Short description of key information:
The substance is not a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
Only one study available. The study is Klimisch 1.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance gave a negative response in a LLNA and is therefore not classified.
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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