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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 journal

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
HYDROTROPES
Author:
OECD SIDS
Year:
2005
Bibliographic source:
HYDROTROPES; OECD SIDS ; SIDS Initial Assessment Report For SIAM 21; 18-20 October 2005, Washington DC, USA
Reference Type:
publication
Title:
Safety Assessment of Various Aryl alkyl hydratropes used in Cosmetics
Author:
Cosmetic Ingredient Review Expert Panel
Year:
2011
Bibliographic source:
International Journal of Toxicology, 2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Buehler test was conducted for the test chemical in Dunkin Hartley guinea pigs according to OECD Guideline 406.
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium 4-methylbenzenesulfonate
Cas Number:
12068-03-0
Molecular formula:
C7H7O3S.Na
IUPAC Name:
sodium 4-methylbenzenesulfonate
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Toluene sulfonic acid, sodium
- Molecular formula: C7H7O3S.Na
- Molecular weight: 194.185 g/mol
- Substance type: organic
- Physical state: solid
- Smiles: S(c1ccc(C)cc1)(=O)(=O)[O-].[Na+]
- InChI: 1S/C7H8O3S.Na/c1-6-2-4-7(5-3-6)11(8,9)10;/h2-5H,1H3,(H,8,9,10);/q;+1/p-1

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: deionized water
Concentration / amount:
42.8 %
Day(s)/duration:
not specified
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: deionized water
Concentration / amount:
42.8 %
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No. of animals per dose:
20
Details on study design:
No data available
Challenge controls:
No data available

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
42.8 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No known skin reactions were observed at induction as well as at challenge exposure.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No known skin reactions were observed at induction as well as at challenge exposure.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
No known skin reactions were observed at induction as well as at challenge exposure. Thus the test chemical was considered to be not sensitizing to the skin of Dunkin Hartley guinea pigs.
Executive summary:

Buehler test was conducted to assess the dermal sensitization potential of the test chemical. The study was performed according to OECD Guideline 406 Guidelines. 20 Dunkin Hartley guinea pigs were used for the study.

In induction, the animals were induced dermally at concentration of 42.8 %. After induction, animals were challenged dermally with the same concentration under occlusive conditions (duration of exposure not mentioned). The guinea pigs were observed for signs of dermal irritation and sensitization (observation duration not mentioned).

No known skin reactions were observed at induction as well as at challenge exposure. Thus the test chemical was considered to be not sensitizing to the skin of Dunkin Hartley guinea pigs.