2-ethylbutyric acid

Skin irritation / corrosion

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.