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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:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
not conducted in compliance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FDA Handbook Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No data available.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: none
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5ml of the test substance was applied to both the intact and abraded skin.

- Concentration (if solution): undiluted

Duration of treatment / exposure:
24 hour(s)
Observation period:
72 hours
Number of animals:
4
Details on study design:
TEST SITE

- Area of exposure: the back of the animal

- % coverage: unspecified.

- Type of wrap if used: The test areas were occluded by means of one inch gauze pads secured with adhesive tape and further occluded with a 'stockinette' sleeve covering the entire trunk of the animal.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): no data, but after 24 hours the patches were removed and the resultant reactions evaluated.


SCORING SYSTEM: Draize scale.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no signs of erythema or edema at any time point. The Primary Irritation Index was 0.0.  The test material was a non-irritant under these conditions.
Other effects:
No other effects reported.

Any other information on results incl. tables

All values were zero at all recorded time points.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A primary irritation index value of zero was determined in a reliable skin irritation study conducted according to generally accepted scientific principles.