Registration Dossier
Registration Dossier
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EC number: 241-680-0 | CAS number: 17691-19-9
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)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety Assessment of Xylene Sulfonic Acid, Toluene Sulfonic Acid, and Alkyl Aryl Sulfonate Hydrotropes as Used in Cosmetics
- Author:
- Wilma F. Bergfeld, Donald V.Belsito, Curtis D. Klaassen, RonaldHill, Daniel Liebler, James G.Marks, Jr, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, F. Alan Andersen
- Year:
- 2 011
- Bibliographic source:
- International Journal of Toxicology; Vol 30, Issue 6_suppl, pp. 270S - 283S; 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- A skin sensitization test was carried out on guinea pigs to determine the sensitizing potential of Sodium toluene-4-sulphonate.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Sodium toluene-4-sulphonate
- EC Number:
- 211-522-5
- EC Name:
- Sodium toluene-4-sulphonate
- Cas Number:
- 657-84-1
- Molecular formula:
- C7H7NaO3S
- IUPAC Name:
- Sodium 4-methylbenzenesulfonate
- Test material form:
- solid
- Details on test material:
- Name of the test chemical: Sodium toluene-4-sulphonate
Molecular Formula: C7H8O3S.Na
Molecular Weight: 194.1853 g/mol
Substance Type: Organic
Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical: Sodium toluene-4-sulphonate
Molecular Formula: C7H8O3S.Na
Molecular Weight: 194.1853 g/mol
Substance Type: Organic
Physical State: Solid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: dermal, occlusive
- Vehicle:
- water
- Concentration / amount:
- 42.8% solution (deionized water)
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: dermal, occlusive
- Vehicle:
- water
- Concentration / amount:
- 42.8% solution (deionized water)
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- no data available
- Details on study design:
- no data available
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 42.8%
- No. with + reactions:
- 0
- Clinical observations:
- no irritation observed at induction and challenge exposure
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No irritation was observed at induction or at challenge exposure.
Under the conditions of this study, it was considered that Sodium toluene-4-sulphonate was not a skin sensitizer. - Executive summary:
A skin sensitization test was carried out on guinea pigs to determine the sensitizing potential of Sodium toluene-4-sulphonate. Guinea pigs were exposed dermally to a 42.8% solution of sodium toluene-4-sulphonate in deionized water under occlusive conditions (number of animals and duration not mentioned). The treated animals were observed for dermal irritation and sensitization effect at induction and challenge exposure.No irritation was observed at induction or at challenge exposure.Under the conditions of this study, it was considered thatSodium toluene-4-sulphonate was not a skin sensitizer.
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