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Toxicological information

Sensitisation data (human)

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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:
1982
Bibliographic source:
Journal of the American college of toxicologists, vol. 1, issue 12, pp. 143-177
Reference Type:
study report
Title:
Unnamed
Year:
1975

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

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: Bath soap and detergent formulation
Details on test material:
No data reported

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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