4-(trifluoromethoxy)aniline

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June to October 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

first version adopted 1981

Deviations:

yes

Remarks:

Experimental procedures are only briefly described

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-(trifluoromethoxy)aniline

EC Number:

207-317-5

EC Name:

4-(trifluoromethoxy)aniline

Cas Number:

461-82-5

Molecular formula:

C7H6F3NO

IUPAC Name:

4-(trifluoromethoxy)aniline

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, England
- Weight at study initiation: 3-4 kg
- Housing: Individually housed in standard rabbit cages
- Diet: rabbit food provided ad libitum
- Water: provided ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

50 mg

Duration of treatment / exposure:

instillation, no rinsing

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: not reported

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: allover assessment, no scoring done

Reversibility:

not specified

Remarks on result:

other: described as moderate irritant in the report

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

The conjunctiva was moderately reddened and swollen for up to 24 hours after application. The iris was slightly reddened and swollen. The cornea was slightly opaque. Only slight redness of the conjunctiva was observed during observation days 2 and 3. Thereafter, no further changes were observed in treated eyes.

Other effects:

None reported

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

In a study conducted in principle similar to the OECD TG 405, redness of the conjunctiva and iris, as well as cornea opacity, were after exposure. Redness diminished after 2 to 3 days after exposure. Thereafter, no further changes were observed in treated eyes. According to the authors of the study, the test material was a moderate eye irritant.

In the absence of scoring values and based on expert judgment, the test material is classified as irritating to the eyes (Category 2) , taking into account the findings as described in the study report, and referring to the conclusion of the study report, that the test material is moderately irritating to the eye.