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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
Study period:
September 1978
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Bandmann's method
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals

Species:
other: human
Strain:
other: human

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact skin
Vehicle:
other: Polyglycol P-4000
Controls:
not required
Amount / concentration applied:
10%
Duration of treatment / exposure:
24 hours
Observation period:
48 hours
Number of animals:
50 subjects
Details on study design:
Patch test on 50 subjects. 0.1g of preparation was applied via a chamber and occluded with a plaster to human skin for 24 hours. Observations were made after 2 and 48 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
other: overall evaluation
Time point:
24/48 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
other: overall evaluation
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
other: overall evaluation
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No reaction observed under the given test conditions

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
10% test substance in Polyglycol 4000 showed no irritation in a human patch test. The preparation has an excellent skin tolerance.
Executive summary:

10% test substance in Polyglycol 4000 showed no irritation in a human patch test. The preparation has an excellent skin tolerance.