Registration Dossier
Registration Dossier
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EC number: 202-896-0 | CAS number: 100-86-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Screening of fragrance materials for allergenicity in the guinea pig I. Comparison four testing methods
- Author:
- G. KLECAK, H. GELEICK, and J. R. FREY
- Year:
- 1 975
- Bibliographic source:
- J. Soc. Cosmet. Chem.,28, 53-64 (February 1977)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- There are available GPMT , OET , DT and FCAT data and they are enough for hazard assessment for skin sensitization.
Test material
- Reference substance name:
- 2-methyl-1-phenylpropan-2-ol
- EC Number:
- 202-896-0
- EC Name:
- 2-methyl-1-phenylpropan-2-ol
- Cas Number:
- 100-86-7
- Molecular formula:
- C10H14O
- IUPAC Name:
- 2-methyl-1-phenylpropan-2-ol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Institute of Biomedical Research, Füllinsdorf, Switzerland
- Weight at study initiation: 400 to 500g
- Diet (e.g. ad libitum): pelleted feed supplemented with green vegetables, carrots and vitamin C
- Water (e.g. ad libitum): drinking water, ad libitum
Study design: in vivo (non-LLNA)
- Details on study design:
- On day 0 the animals were injected intradermally with 0.1 ml of a 5 percent solution of the compound tested, with 0.1 ml of a 5 percent emulsion of the same compound in Freund's complete adjuvant (FCA) and with 0.1 ml of FCA alone, each injection being given twice. In addition, 250 mg of the compound dissolved in petrolatum at a concentration of 25 percent, which always causes mild to moderate skin irritation under occlusionw, asa pplied on day 8 to a clipped skin area of the neck and was kept under occlusive bandage for 2 days (total dose 20 mg intradermally plus 250 mg epicutaneously). On day 21 an occlusive patch test with the compound at a subirritant concentrationin petrolatum was applied to the flank for 24 h. The reactions were read 24 and 48 h after removing the patch.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- test chemical
- Remarks on result:
- no indication of skin sensitisation
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
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