Registration Dossier
Registration Dossier
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EC number: 201-283-5 | CAS number: 80-48-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
- Principles of method if other than guideline:
- Repeated exposure of the substance to the intact skin for 10 treatments, followed by exposure to a previously untreated site after a period of 17 days continuous non-exposure.
- GLP compliance:
- no
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- The data are historically available data involving exposure to animals, but suitably demonstrates a positive response
Test material
- Reference substance name:
- Methyl toluene-4-sulphonate
- EC Number:
- 201-283-5
- EC Name:
- Methyl toluene-4-sulphonate
- Cas Number:
- 80-48-8
- Molecular formula:
- C8H10O3S
- IUPAC Name:
- methyl 4-methylbenzene-1-sulfonate
- Test material form:
- not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (LLNA)
- Vehicle:
- other: ether
- Concentration:
- 10%
- No. of animals per dose:
- 10 test and 3 control
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% in ether
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- blotchy reedness
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The substance is sensitising under the conditions of the test.
- Executive summary:
The sensitising effect of the substance has been assessed by reapeted expsoure of a 10% solutioin in ether exposed to guinea pigs. The test solution has been applied to the intact, naked skin of 10 guiea pigs with ten repeated applications over a period of 5 days. Following a period of 17 days without expsoure to the substance, the test solution was then applied to the naked skin a previously unexposed area of the guiea pigs and the reactions assessed compared to the control animals which were treated only with ether.
In the study 8 of the 10 test animals showed blotchy redness deemed to be a senstising effect of the test substance.
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