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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:
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:
1967
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

Constituent 1
Chemical structure
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

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.