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Dermal absorption

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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:
1982
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:
1960
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

Constituent 1
Chemical structure
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
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.