Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation / corrosion

Currently viewing:

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

Constituent 1
Chemical structure
Reference substance name:
Stearic acid
EC Number:
200-313-4
EC Name:
Stearic acid
Cas Number:
57-11-4
Molecular formula:
C18H36O2
IUPAC Name:
stearic acid
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."