Registration Dossier
Registration Dossier
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EC number: 246-680-4 | CAS number: 25155-30-0
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- other: Human observational study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 997
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
- Reference substance name:
- C12-LAS
- IUPAC Name:
- C12-LAS
- Details on test material:
- LAS; activity: 30.0%
Constituent 1
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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