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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
07/03/1995-15/03/1995
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified

Test animals

Species:
rabbit
Strain:
other: Japanese white

Test system

Type of coverage:
not specified
Amount / concentration applied:
0.5 ml
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
other: Individual scores were not reported
Remarks:
Please see below for qualitative results
Basis:
other:
Time point:
other: Results after 3 min, 60 min and 4 h are given in the table below
Irritant / corrosive response data:
Within 60 minutes of exposure all animals exibited very mild erythema and mild-moderate edema.
Erythema and edema observed after 24 hours disappeared with the passage of time.
Desquamation was observed in all cases by 8th day at which point the observation was stopped.

Any other information on results incl. tables

 Time  3 min  60 min  4 hours
 Result (No. of animals)  Very mild erythema (2/3)  very mild erythema (3/3)  Very mild erythema (3/3)
     Mild and moderate edema (3/3)    Mild and moderate edema (3/3)

 

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
As no erythma or edema scores are reported the study alone cannot be used for classification. However, the results the results indicate the substance may be irritating to skin and should be considered in a weight of evidence approach.
Executive summary:

A test to determine the corrosive effects of 2 -ehtylbutyric acid was carried out on rabbits. It was not specified in the study which test guideline was followed. 3 rabbits were exposed to 0.5 ml of the substance and observed for 8 days. Within 60 minutes all animals exibited very mild erythema and  mild and moderate edema. The observed erythema and edema dissappeared over the course of the study and after 8 days desquamation was observed. After 8 days the animals were deemed to be in recovery and as a result the observation period was ended. The study is not of sufficient quality to draw a conclusion on classification but the results indicate the substance may be irritating but not corrosive to skin.

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