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Toxicological information

Skin sensitisation

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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:
2011
Bibliographic source:
International Journal of Toxicology; Vol 30, Issue 6_suppl, pp. 270S - 283S; 2011

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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
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 group
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.