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, other
- Remarks:
- Human Patch test data
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Human Patch Test data
- Justification for type of information:
- Patch testing on 4 patients (out of 2,000 treated, 10 complainants) who showed reactions to Scutan, a polyether impression material. Methyl toluene-4-sulphonate was identified as the catalyst component.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Version / remarks:
- Human patch test data.
- Principles of method if other than guideline:
- Human patch test data.
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- Human patch test data.
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
Constituent 1
In vivo test system
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- n/a
Results and discussion
In vitro / in chemico
Results
- Parameter:
- other:
- Remarks on result:
- other: Not applicable - Human patch test data.
In vivo (non-LLNA)
Results
- Remarks on result:
- other: Human patch test data.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- In the department of prosthetic dentistry at Groningen from 1971-1975, approximately 2,000 persons have been treated with Scutan, and epimine plastic for temporary crowns and bridges and Impregum, a polyether impression material. A total of ten patients complained of untoward reactions.
Patch tests with the basic materials were performed on four of the ten complainants. Positive allergic reactions were obtained to patch tests with the catalyst methyl p. toluene sulphonate 0.1% in dibenzyltoluol present in Scutan, and the catalyst methyldichlorobenzene sulphonate 0.1% in dibenzyltoluol present in Impregum. Four control subjects did not react to these concentrations.
The substance is identified as a human skin sensitiser. Because of the low reported incidence, the substance is regarded as low potency, indicating classification as Skin Sensitiser GHS category 1B.
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