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

Endpoint summary

Description of key information

Study conducted to recognised testing guidelines prior to the standardisation of GLP certification.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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.

Species:

rabbit

Strain:

New Zealand White

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.42

Version / remarks:

27 September 1973

Deviations:

no

GLP compliance:

no

Remarks:

Study conducted prior to GLP guidelines and regulations.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Animals free from visible ocular defects.

Vehicle:

other: Corn oil

Controls:

other: Only one eye in each animal was treated, the untreated eye served as the control.

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 7 days

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 7 days

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 7 days

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4 d

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 7 days

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

The test article is not an ocular irritant to rabbits under the conditions of the test.

Interpretation of results:

GHS criteria not met

Conclusions:

The test articles was not considered an ocular irritant to rabbits under the conditions of the test.

Executive summary:

Siz New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of 0.1 ml the test article in one eye. The contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours. Observations of corneal opacity, iritis, and conjunctivitis were recorded 24, 48, and 72 hours after treatment, and at 4 and 7 days if irritation persisted. The test article was used as a 25% gravimetric corn oil suspension.

This test article is not an ocular irritant to rabbits under the conditions of the test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The registered substance does not fulfill the criteria for eye irritation or skin irritation according to the Classification, Labelling, and Packaging (CLP) regulation (1272/2008).