2,4-difluoroaniline

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

occlusive instead of semi-occlusive dressing

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 402 (Acute Dermal Toxicity)

Version / remarks:

adopted in 2017

Deviations:

yes

Remarks:

occlusive instead of semi-occlusive dressing

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 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:

rat

Strain:

other: CD (Sprague Dawley)

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

Doses:

0.31, 0.62 or 1.25 mL/kg bw (corresponding to doses of approx. 393, 786 and 1585 mg/kg bw based on a density of 1.268 g/mL obtained from the literature (NTP, 1992))

No. of animals per sex per dose:

5 male and 5 female rats

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

0.8 mL/kg bw

Based on:

test mat.

95% CL:

> 0.61 - < 1.05

Remarks on result:

other: No mortality occured at 0.31 mL/kg bw. 1/5 males and 1/5 females died at 0.62 mL/kg bw and 5/5 males and 5/5 females dies at 1.2 mL/kg bw.

Remarks:

The LD50 is corresponding to a dose of 1014 mg/kg bw based on a density of 1.268 g/mL.

Applicant's summary and conclusion

Interpretation of results:

other: acute dermal toxicity observed

Conclusions:

In this acute dermal toxicity test in rats, no mortalities occured at a dose of 0.31 mL/kg bw. 1/5 male and 1/5 female rats died at a dose of 0.62 mL/kg bw and 5/5 males and 5/5 females died at a dose of 1.25 mL/kg bw. Clinical signs included prostration, tremors, sedation, dacryohaemorrhoea, a loss of righting reflex, salivation, an apparent hypothermia and a slight thinness. Apart from a slight yellow staining, the skin remained normal during the study. At necropsy one female rat in the 0.62 mL/kg bw group which died prematurely had a very pale liver. For all remaining animals necropsy revealed no abnormalities at any dose level. The LD50 value was calculated to be 0.80 mL/kg bw (corresponding to a dose of 1014 mg/kg bw based on a density of 1.268 g/mL). Based on the results and according to EU GHS classification criteria, the test substance has to be classified.