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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: published data
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Justification for type of information:
C12 LAS; Linear Alkylbenzene Sulfonate (LAS)) is a very close analogue of Calcium dodecylbenzenesulfonate (CAS No 26264-06-2, EC Number; 247-557-8) ) and read-across is valid.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1997

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to guideline
Guideline:
other: Human Repeat Insult Patch Test
Principles of method if other than guideline:
Human Repeat Insult Patch Test
Method:LAS was applied at 0.10% (w/v) on the upper arms of volunteers, under occlusive patch conditions. Test material was applied for 24 hours, 3 times a week, for 3 weeks during the induction period. After a 14-17-day rest, a 24- hour challenge patch was applied on the original and alternate arm sites.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
C12-LAS
IUPAC Name:
C12-LAS
Details on test material:
LAS; activity: 30.0%

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
95 volunteers were treated with LAS at 0.10% (w/v) on the upper arms, under occlusive patch conditions.
Route of administration:
dermal
Details on study design:
LAS was applied at 0.10% (w/v) on the upper arms of volunteers, under occlusive patch conditions. Test material was applied for 24 hours, 3 times a
week, for 3 weeks during the induction period. After a 14-17-day rest, a 24- hour challenge patch was applied on the original and alternate arm sites.

Results and discussion

Results of examinations:
There was no evidence of skin sensitization on the 95 subjects who completed the test.

Applicant's summary and conclusion

Conclusions:
95 volunteers were treated with LAS at 0.10% (w/v) on the upper arms, under occlusive patch conditions. Test material was applied for 24 hours, 3 times a week, for 3 weeks during the induction period. After a 14- to 17-day rest, a 24-hour challenge patch was applied on the original and alternate arm sites.
There was no evidence of skin sensitisation on the 95 subjects who completed the test.
Executive summary:

95 volunteers were treated with LAS at 0.10% (w/v) on the upper arms, under occlusive patch conditions. Test material was applied for 24 hours, 3 times a week, for 3 weeks during the induction period. After a 14- to 17-day rest, a 24-hour challenge patch was applied on the original and alternate arm sites.

There was no evidence of skin sensitisation on the 95 subjects who completed the test.

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