Registration Dossier
Registration Dossier
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EC number: 286-484-6 | CAS number: 85251-71-4
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption
- 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:
- publication
- Title:
- The penetration of the human skin by fatty alcohol sulfates and sodium soaps of fatty acids (C8-C18) and its relation to causes of irritation
- Author:
- Szakall A, Schulz KH
- Year:
- 1 960
- Bibliographic source:
- Fette Seifen Anstrichm., vol. 62, pp. 170-175 cited in CIR (1982)
Materials and methods
- Principles of method if other than guideline:
- - Method: Humans were exposed to 0.5 % sodium stearate in aqueous solution and the rate of penetration through skin was assessed.
- 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: Aqueous solution
- Details on test material:
- No data reported
Constituent 1
- Radiolabelling:
- not specified
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data reported
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Duration of exposure:
- No data reported
- Doses:
- - Concentration: 0.5 % sodium stearate in aqueous solution
- No. of animals per group:
- No data reported
- Details on study design:
- No data reported
- Details on in vitro test system (if applicable):
- No data reported
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- - Rate of penetration: 0.1 mg/ 100 mL/ minute through human skin
- Total recovery:
- No data reported
- Conversion factor human vs. animal skin:
- Not applicable
Applicant's summary and conclusion
- Conclusions:
- The rate of penetration of 0.5 % sodium stearate in aqueous solution through human skin was determined to be 0.1 mg/ 100 mL/ minute.
- Executive summary:
The rate of penetration of 0.5 % sodium stearate in aqueous solution through human skin was determined to be 0.1 mg/ 100 mL/ minute. 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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