2,4-difluoroaniline

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Observation period ended 72 h after removal of patches and reversibility of skin irritation was not further reported; 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 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

Deviations:

yes

Remarks:

Observation period ended 72 h after removal of patches and reversibility of skin irritation was not further reported; no purity of the test susbtance 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

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 1 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

3 males and 3 females

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Until 24 h after application animals had a purple staining at the application side, not allowing proper scoring. Thus, 24 h values were assumed to be the same as those at 48 h (worst case assumption).

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 2 animals

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: Until 24 h after application animals had a purple staining at the application side, not allowing proper scoring. Thus, 24 h values were assumed to be the same as those at 48 h (worst case assumption).

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

In this skin irritation test in rabbits, a purple staining due to the intensive intrinsic colour of the test substance was apparent at the application side until 24 h after application, not allowing proper scoring. Thus, 24 h values were assumed to be the same as those at 48 h (worst case assumption). At 48 h 5/6 animals exhibited a grade 1 erythema, which was reversible in 2/5 animals within 72 h and persisted in 3/5 for at least 72 h. No edema was reported for any of the animals. Since observation period ended at 72 h, reversibility of effects is not proven. Therefore, this study cannot be used for classification purposes.