Registration Dossier

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:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Open Epicutaneous (In Vivo) Study
GLP compliance:
no

Test material

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

Test animals

Species:
guinea pig
Strain:
not specified

Test system

Type of coverage:
open
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
All substances were applied undiluted as well as dissolved in acetone, ethanol or diethylphthalate etc. at concentrations of 30, 10, 3, 1, 0.3, 0.1 and 0.03% in order to establish a dose response curve which would permit the determination of the minimal irritating and maximal tolerated concentrations on an "all or none" basis.
Duration of treatment / exposure:
21 daily applications
Number of animals:
6-8 animals per concentration

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: After single application
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Non-Irritant.
Executive summary:

After a single application at 100%, only slight irritation was observed. No irritation was observed at 30%.