2,4-difluoroaniline

Eye irritation

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:

comparable to guideline study with acceptable restrictions

Remarks:

no purity of the test substance given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 2017

Deviations:

yes

Remarks:

no purity of the test substance given

GLP compliance:

not specified

Test material

Test material information

1

Reference substance name:

2,4-difluoroaniline

EC Number:

206-687-5

EC Name:

2,4-difluoroaniline

Cas Number:

367-25-9

Molecular formula:

C6H5F2N

IUPAC Name:

2,4-difluoroaniline

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

7 days
Observation time points: 1, 6, 24, 48, 72 h and 4 and 7 days after treatment

Number of animals or in vitro replicates:

3 female rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Any other information on results incl. tables

In a second group of 3 animals, treated eyes were irrigated with tap water 1 min after instillation of the test substance. The results obtained were comparable to the results of non-irrigated method. Since this method is not according to guideline, the results are not reported and evaluated here.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

In this eye irrritation test in female rabbits, the test substance caused conjunctival redness (score 1) in 3/3 animals and chemosis (score 1-2 ) in 3/3 animals 1 h after instillation of the test substance without irrigation. After 24 h conjunctival redness and chemosis was still observed in 2/3 animals. Conjunctival redness and chemosis were fully reversible within 48 h in one animal and within 7 days in the remaining animal. Mean 24/48/72h scores (Draize) for conjunctival redness and chemosis were 0, 1.0 and 0.33 and 0, 1.33 and 0.33 for the 3 animals, respectively. No lesions of the cornea or iris were observed. The test material is therefore considered not to be irritating to the eye and no classification is required according to EU classification criteria.