Methyl anthranilate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Eye irritation potential of test chemical

Author:

Carpenter et. al.

Year:

1946

Bibliographic source:

American Journal of Ophthalmology, 1946

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the ocular irritation potential of the test chemical

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 2-hydroxybenzoate

Cas Number:

119-36-8

Molecular formula:

C8H8O3

IUPAC Name:

Methyl 2-hydroxybenzoate

Test material form:

liquid

Details on test material:

Name of test material (as cited in study report): methyl salicylate
Molecular formula : C8H8O3
Molecular weight : 152.15.g/mol
Physical state: Liquid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.005 ml. of the undiluted material

Duration of treatment / exposure:

0.005 ml. of the undiluted material is applied to the center of the cornea while the lids are retracted. (exact duration - not specified)

Observation period (in vivo):

Eighteen to 24 hours

Number of animals or in vitro replicates:

no data

Details on study design:

Normal albino rabbit eyes were selected on the basis of absence of grossly visible staining by a 5-percent aqueous solution of fluorescein sodium, flushed with distilled water 20 seconds after application. A 2 hour interval was given so that the eye could return back to normal condition. Then, 0.005 ml of the undiluted test material was applied to the center of the cornea while the lids were retracted. About one minute later, the lids were released. This procedure is necessary to prevent the removal of a portion of the dose by the very efficient wiping system of the lids before intimate contact has been made with the eye. 18 to 24 hours later, the eyes were examined in strong diffuse daylight, then stained with fluorescein, and the injury was scored.
SCORING SYSTEM: 24 hours after the application of the test chemical

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Remarks:

Grade 3 and Grade 9 injury was recorded

Irritant / corrosive response data:

Grade 3 and Grade 9 injury was recorded
The test chemical was known to have caused loss of vision or very slowly healing corneal burns.

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (irritating to eyes) as per CLP criteria of classification and labelling.

Conclusions:

The test chemical was grouped under Grade 3 injury (0.1 ml undiluted gives injury of up to 5 points (0.5 ml gives over 5)) and Grade 9 injury (Excess of 1% solution gives injury up to 5 points (5% gives over 5)) when rabbit eyes were observed for injuries. The test chemical was known to have caused loss of vision or very slowly healing corneal burns. Based on these grades, it can be inferred that the test chemical was irritating to rabbit eyes.

Executive summary:

An eye irritation test was conducted to assess the irritation potency of the test chemical. Normal albino rabbit eyes were selected on the basis of absence of grossly visible staining by a 5-percent aqueous solution of fluorescein sodium, flushed with distilled water 20 seconds after application. A 2 hour interval was given so that the eye could return back to normal condition. Then, 0.005 ml of the undiluted test material was applied to the center of the cornea while the lids were retracted. About one minute later, the lids were released. This procedure is necessary to prevent the removal of a portion of the dose by the very efficient wiping system of the lids before intimate contact has been made with the eye. 18 to 24 hours later, the eyes were examined in strong diffuse daylight, then stained with fluorescein, and the injury was scored. The test chemical was grouped under Grade 3 injury (0.1 ml undiluted gives injury of up to 5 points (0.5 ml gives over 5)) and Grade 9 injury (Excess of 1% solution gives injury up to 5 points (5% gives over 5)) when rabbit eyes were observed for injuries. The test chemical was known to have caused loss of vision or very slowly healing corneal burns. Based on these grades, it can be inferred that the test chemical was irritating to rabbit eyes.