Hexanoic acid, 2-ethyl-, C12-15-alkyl esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.41

Version / remarks:

27 September 1973

Deviations:

no

GLP compliance:

no

Remarks:

Study conducted prior to GLP guidelines and regulations.

Test material

Test material information

Constituent 1

Reference substance name:

Hexanoic acid, 2-ethyl-, C12-15-alkyl esters

EC Number:

291-443-0

EC Name:

Hexanoic acid, 2-ethyl-, C12-15-alkyl esters

Cas Number:

90411-66-8

IUPAC Name:

Hexanoic acid, 2-ethyl-, C12-15-alkyl esters

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Each animal had two test sites, one abraded, one intact.

Vehicle:

other: Corn oil

Controls:

not specified

Amount / concentration applied:

0.5 ml applied. The test article was used as a 10% gravimetric corn oil suspension.

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

OBSERVATION TIME POINTS
24 and 72 hours after application.

SCORING SYSTEM:
Scored according to the test guideline.
Mean scores from the 24 and 72 hour readings were averaged to determine the primary irritation index.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24h & 72h

Score:

0.2

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

The test articles is not a primary dermal irritant to rabbits under the conditions of the test.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The primary irritation index of the test article for dermal irritation in the rabbit was determined to be 0.2 under the condictions of the test. The primary irritation index is too low for any of the individual scores to meet the criteria of the Classification, Labelling, and Packaging (CLP) regulation. In addition, irritation was fully reversible within 72 hours.

Executive summary:

Six New Zealand white rabbits each received a single dermal application of 0.5 ml if the test article on two test sites, one abraded, one intact. The test sites were occluded for 24 hours and were observed individually for erythema, edema, and other effects 24 and 72 hours after application. Mean scores from the 24 and 72 hour readings were averaged to determine the primary irritation index. The test article was used as a 10% gravimetric corn oil suspension.

Primary Irritation Index: 0.2

The test article is not a primary dermal irritant to rabbits under the conditions of this test.