Registration Dossier
Registration Dossier
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EC number: 246-680-4 | CAS number: 25155-30-0
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- other: Human observational study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- acute toxicity: dermal
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method:0.04, 0.4, and 4% aqueous solutions of LAS were applied in 48-h closed-patch tests on the lower backs of 20 women with hand eczema and 42 with other skin diseases. The skin reaction was scored grossly from 0 to 5 on the basis of the occurrence or intensity of erythema, papules, and vesicles.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- C12-LAS
- IUPAC Name:
- C12-LAS
- Details on test material:
- C12-LAS
Constituent 1
Method
- Type of population:
- general
- Subjects:
- 20 women with hand eczema and 42 with other skin diseases.
- Ethical approval:
- confirmed, but no further information available
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- In order to assess the possible etiological correlation between exposure to LAS and hand eczema, 0.04, 0.4, and 4% aqueous solutions of LAS were applied in 48-h closed-patch tests on the lower backs of 20 women with hand eczema and 42 with other skin diseases.
- Examinations:
- The skin reaction was scored grossly from 0 to 5 on the basis of the occurrence or intensity of erythema, papules, and vesicles.
Results and discussion
- Results of examinations:
- The skin reaction was scored grossly from 0 to 5 on the basis of the occurrence or intensity of erythema, papules, and vesicles.
The average score appeared to increase in parallel with the concentration of LAS but did not differ between the groups with hand eczema and other skin diseases
Applicant's summary and conclusion
- Conclusions:
- The skin reaction was scored grossly from 0 to 5 on the basis of the occurrence or intensity of erythema, papules, and vesicles.
The average score appeared to increase in parallel with the concentration of LAS but did not differ between the groups with hand eczema and other skin diseases .Solutions ofLAS do not induce hand eczema in humans.
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