Registration Dossier
Registration Dossier
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EC number: 943-554-7 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study done to guideline and following the principles of GLP.
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 442C
- Deviations:
- yes
- Remarks:
- Additional analytical data acquired using LC-MS analysis.
- GLP compliance:
- no
- Type of study:
- other: DPRA
Test material
- Reference substance name:
- Azarbre
- IUPAC Name:
- Azarbre
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- Please note that although the substance is stated as the mono-constituent substance 2-cyclohexen-1-one, 3,5-diethyl-5,6-dimethyl (3,5-diethyl-2,5-dimethyl) in the report, analytical data on the same batch shows that the test substance is in fact the multi-constituent substance Reaction mass of 3,5-diethyl-2,5-dimethyl-cyclohex-2-en-1-one and 3,5-diethyl-5,6-dimethylcyclohex-2-en-1-one .
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Parameter:
- other:
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
When using HPLC-UV analysis only, AZARBRE led to 43.1% depletion of the Cys-peptide. It was therefore considered reactive and classified into the LOW reactivity class according to the classical DPRA prediction model. When samples were analysed with high resolution LC-MS, the same amount of peptide depletion was observed. However, no direct adduct was formed in samples with the test chemical. At the same time the test chemical triggered significantly enhanced peptide dimerization, and the observed peptide depletion can be attributed to peptide oxidation rather than adduct formation. Thus, based on this more sophisticated and detailed analysis the test chemical is not directly peptide reactive and the assay does not indicate sensitization potential for Azarbre.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on this more sophisticated and detailed analysis the test chemical is not directly peptide reactive and the assay does not indicate sensitization potential for Azarbre.
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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