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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

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.