Registration Dossier
Registration Dossier
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EC number: 286-484-6 | CAS number: 85251-71-4
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: GLP-status not known, guideline not known, information from a peer-reviewed, published review article. Notable limitations in design and/or reporting, reliability not known.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Final report of the safety assessment of lithium stearate, aluminum distearate, aluminum stearate, aluminum tristearate, ammonium stearate, calcium stearate, magnesium stearate, potassium stearate, sodium stearate and zinc stearate
- Author:
- Cosmetics Ingredients Review
- Year:
- 1 982
- Bibliographic source:
- Journal of the American college of toxicologists, vol. 1, issue 12, pp. 143-177
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- not specified
- Principles of method if other than guideline:
- - Method: 1 % bath and soap formulation in an aqueous soap solution containing 0.1-0.25 % sodium stearate was applied in a 21-day patch test on 10 subjects.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium stearate
- EC Number:
- 212-490-5
- EC Name:
- Sodium stearate
- Cas Number:
- 822-16-2
- Molecular formula:
- C18H36O2.Na
- IUPAC Name:
- sodium stearate
- Test material form:
- other: Bath soap and detergent formulation
- Details on test material:
- No data reported
Constituent 1
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- No data reported
- Clinical history:
- No data reported
- Controls:
- No data reported
- Route of administration:
- dermal
- Details on study design:
- - Method: 1 % bath and soap formulation in an aqueous soap solution containing 0.1-0.25 % sodium stearate was applied in a 21-day patch test on 10 subjects.
Results and discussion
- Results of examinations:
- - Results: The solution was observed to be minimally irritating.
Applicant's summary and conclusion
- Conclusions:
- 1 % bath and soap formulation in an aqueous soap solution containing 0.1-0.25 % sodium stearate was applied in a 21-day patch test on 10 subjects and found to be minimally irritating.
- Executive summary:
1 % bath and soap formulation in an aqueous soap solution containing 0.1-0.25 % sodium stearate was applied in a 21-day patch test on 10 subjects and found to be minimally irritating. No information on the test methods used is available in the publication (CIR 1982). However, this information is taken from a peer reviewed article and can be considered adequate for use for this endpoint.
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