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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Skin irritation data for 57-11-4
Year:
1977
Bibliographic source:
Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill,V.A., and P. Lazar, eds., New York, Academic Press, Inc. 1977 Volume(issue)/page/year: -,127,1977
Reference Type:
review article or handbook
Title:
RTECS NUMBER : WI2800000
Author:
RTECS Database
Year:
2012
Bibliographic source:
RTECS (Registry of Toxic Effects of Chemical Substances);"Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill,V.A., and P. Lazar, eds., New York, Academic Press, Inc. 1977 Volume(issue)/page/year: -,127,1977

Materials and methods

Principles of method if other than guideline:
Standard Draize test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):Stearic acid
- Molecular formula:C18H36O2
- Substance type:Organic

Test animals

Species:
human

Test system

Type of coverage:
open
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
75 mg
Duration of treatment / exposure:
3D (Intermittent)

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 3 Days
Reversibility:
no data
Remarks on result:
other: Mild irritant

Applicant's summary and conclusion

Interpretation of results:
other: mild irritant
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Skin irritation tests performed by the method of Standard Draize test,75 mg of Stearic acid applied to the skin of human subjects for 3 days where the dosage of stearic acid was given intermittently, resulted in a mild irritation effect." The substance Stearic acid is thus considered "mildly irritating."
Executive summary:

Skin irritation tests performed by the method of Standard Draize test,75 mg of Stearic acid applied to the skin of human subjects for 3 days where the dosage of stearic acid was given intermittently, resulted in a mild irritation effect." The substance Stearic acid is thus considered "mildly irritating."