α,α,α-trifluoro-o-toluidine

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:

other: Study well detailed, but not GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Remarks:

The test was done before the guideline was available

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

α,α,α-trifluoro-o-toluidine

EC Number:

201-806-7

EC Name:

α,α,α-trifluoro-o-toluidine

Cas Number:

88-17-5

Molecular formula:

C7H6F3N

IUPAC Name:

2-(trifluoromethyl)aniline

Constituent 2

Reference substance name:

alpha,alpha,alpha-trifluoro-o-toluidine

IUPAC Name:

alpha,alpha,alpha-trifluoro-o-toluidine

Details on test material:

Impurities: no data
lot/batch No: LE 5452

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Les Oncins, IFFA CREDO
- Weight at study initiation: 140 to 180 g
No more data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: On the shaved back
- % coverage: 6 x 6 cm
- Type of wrap if used: aluminium + adhesive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): soapy lukewarm tap water
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

2220, 3330, 5000, 7500 mg/kg

No. of animals per sex per dose:

5

Control animals:

yes, concurrent no treatment

Details on study design:

A preliminary test was done on 2 males and 2 females to determine the toxicity in order to choose doses for the main test.

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: every 5 days for the highest doses without mortality.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Statistics:

Calculation according to the method of Dragstedt and Lang.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 700 mg/kg bw

Based on:

test mat.

Mortality:

2200 mg/kg: 1/10 died on D1
3330 mg/kg: no mortality
5000 mg/kg: 6/10 animals died on D1
7500 mg/kg: 9/10 animals died between 2h and D1

Clinical signs:

other: All animals at all doses cried immediately after application. 2200 mg/kg: After 2h, piloerection, flushed limbs 3330 mg/kg: After 2h, reduced spontaneous activity, flushed limbs and ears. 5000 mg/kg: After 2h, prostration, increase of cutaneous temperatur

Gross pathology:

no

Other findings:

no

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

With a LD50 at 4700 mg/kg, o-trifluoromethylaniline is not classified according to the CLP 1272/2008/EC criteria.

Executive summary:

In an acute dermal toxicity study (IFREB n°8 03 103), groups of Sprague-Dawley rats (male/female) were dermally exposed to o-trifluoromethylaniline for 24 hours to a dorsal area of 6*6 cm, at doses of 2220, 3330, 5000 and 7500 mg/kg bw. Animals then were observed for 15 days.

Dermal LD50 Combined = 4700 mg/kg bw.

Based on the LD50 in males and females, o-trifluoromethylaniline is not classified for toxicity by dermal exposition according to the CLP 1272/2008/EC criteria.