Schiff bases, benzylidene, C16-18 (even numbered) and C18-unsaturated alkyl

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21st July 1982-28th July 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Schiff bases, benzylidene, C16-18 (even numbered) and C18-unsaturated alkyl

Molecular formula:

Not applicable - UVCB

IUPAC Name:

Schiff bases, benzylidene, C16-18 (even numbered) and C18-unsaturated alkyl

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Six rabbits were selected based upon body weight and kept for 5 days acclimation period. Cages were marked with an animal group number and dose level. All Rabbits were ear tagged. Light cycle of 12hours light , 12hours dark. Every attempt was made to maintain a temperature of 20oC +/-3oC and a humidity of 30-70%. Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the institute of Laboratory resources, National Research Council. Waste material was removed daily and cages and feeders were sanitized every two weeks. Food and water was provided ad libitum and checked daily, added or replaced as required.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Only one eye was treated with Test material the other eye served as control.

Amount / concentration applied:

0.1ml

Duration of treatment / exposure:

Test substance was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball to form a cup. The upper and lower lids were then held together for one seconf to prevent loss of material

Observation period (in vivo):

7 days

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within:

Remarks:

7days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within:

Remarks:

7days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.623

Reversibility:

fully reversible within:

Remarks:

7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

2.12

Reversibility:

fully reversible within:

Remarks:

7days

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Based upon the observations made in the Acute Eye Irritation Test in Rabbits, the test substances is determined to be an eye irritant. Therefore, in accordance with the criteria set forth by the CLP cguidances, the test substance will be classified as Eye irritant , Cat. 2, H319.

Executive summary:

Six animals (3 males and 3 females) were exposed to 0.1ml of the test substance. Positive occular responses were observed at 1, 24,48,72hours after treatment. No positive responses were observed on day 7, at which time the study was terminated. Seventeen positive responses were redoed during the course of the study. Immediately following the 48 hour reading a rabbit died. However, necropsy revealed the death was non- compound related. Based upon the observations made in the Acute Eye Irritation Test in rabbits, the test substances is determined to be an eye irritant. Therefore, in accordance with the criteria set forth by the CLP cguidances, the test substance will be classified as Eye irritant , Cat. 2, H319.