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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from experimental report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Modified Federal Hazardous Labelling Act
Principles of method if other than guideline:
The test was designed to investigate the irritation effects of test chemical when applied to the one eye of single rabbits.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,2,2-trichloro-1-phenylethyl acetate (rosacetone)
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Age at study initiation: aged 7-9 weeks
- Weight at study initiation:weighing between 1-2 Kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
10 mg
Duration of treatment / exposure:
24 hrs.
Observation period (in vivo):
15 min. after application
24 hrs. after application
daily intervals for 5 days per week for 3 weeks
Number of animals or in vitro replicates:
6 animals
Details on study design:
The lower eyelid is gently pulled away from the globe and 10 mg of test substance applied into the cup so formed ;the eyelid then release. The rabbit was inspected with hand torch before any treatment and those with spontaneous eye lesions are rejected.Flurescein is applied to eye to assist in the detection of corneal lesions.Corneal thickness is also measured before the application ot test material

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test chemical caused no corneal, conjunctival, or iridial damage 24 hours after treatment.

Any other information on results incl. tables

Table 1: Summary of test result

Experimental group

No of rabbits

Discomfort

Number of rabbits with stated ocular lesion

Positive conjunctival reactions

No. with iritis

No. with pannus

Maximum corneal opacity

Duration of opacity

Maximum corneal swelling

0.5

1

2

3

4

>1 on day 8

>0.5 on day 8

Nil (0-10%)

Slight (11-45%)

Moderate (46-80%)

Severe (81%+)

A

1

-

-

-

-

-

-

-

-

-

-

-

1

-

-

-

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
The test chemical caused no corneal, conjunctival, or iridial damage 24 hours after treatment at concentration of 10mg. Hence, the test material can be considered to be not irritating to New Zealand White rabbit eyes.
Executive summary:

An eye irritation study was conducted in accordance with Modified Federal Hazardous Labelling Act Method by using a single rabbit.

The rabbit was inspected with a hand torch before any treatment and those without any serious corneal lesions were taken. Corneal thickness was also measured before the start of the test. The lower eyelid was gently pulled away from the globe and 10 mg of test substance applied on one eye into the cup so formed; the eyelid was then released.

Animal was watched during and immediately after the application of the test chemical. 15 minutes after the application of the test chemical the eyes were observed for conjunctival reactions. One day after the application of test material and then at daily intervals for five days per week for three weeks or until the eye is completely clear. Fluorescein was applied to eyes to assist in the detection of corneal lesions.

Each day after application of the test chemical, the corneal thickness was measured using a slit lamp. Corneal swelling was expressed as:

(Corneal thickness on day of measurement)/(Corneal thickness on before treatment)-1)*100%.

The test chemical caused no corneal, conjunctival, or iridial damage 24 hours after treatment at tested concentration of 10 mg.

Hence, the test chemical can be considered to be not irritating to New Zealand White rabbit eyes.