α,α,α-trifluoro-p-toluidine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 26 jun 1985 to 24 feb 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to the standardised method and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: according to EU directive 79/831 and according to OECD guideline

Deviations:

yes

Remarks:

surface area application is not mentionned in the report

GLP compliance:

yes

Test type:

other: limit test

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

α,α,α-trifluoro-p-toluidine

EC Number:

207-236-5

EC Name:

α,α,α-trifluoro-p-toluidine

Cas Number:

455-14-1

Molecular formula:

C7H6F3N

IUPAC Name:

4-(trifluoromethyl)aniline

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Species: COMMON SPECIES: rat
- Strain: RAT STRAINS: Sprague-Dawley
- Sex: male/female
- Source: IFFA Credo (69510 St Germain sur l'Arbresle)
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 170-200 g (male), 150-180 g (female)
- Fasting period before study: no data
- Housing : individually. Stainless steel cage: 171*126*70 mm
- Food consumption: UAR entretien A04, ad libitum
- Water consumption:ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/-3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 10 removes
- Photoperiod (hrs dark / hrs light): no data

In-life dates: not specified

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: lateral-dorsal
- Type of wrap if used: perfored adhesive tape on gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.54 ml/kg
- Concentration (if solution): substance as it is
- Constant volume or concentration used: yes

VEHICLE: none

Duration of exposure:

24 hours

Doses:

0, 2002 mg/kg

No. of animals per sex per dose:

5

Control animals:

other: yes, distilled water

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Behaviour and mortality: at 1, 2 and 4 hours after exposure and then daily until day 14.
- weighing: at day 1, 2, 8 and 15 and then when animals died.
- Dermal observation: at day 2 and then daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ examination/

Statistics:

none

Results and discussion

Preliminary study:

Doses tested: 1001 and 2002 mg/kg on 4 animals per group (2 males and 2 females). No mortality observed.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 002 mg/kg bw

Remarks on result:

other: no mortality observed at high dose tested during preliminary study with 4 animals of both sexes, and 10% of females died at this dose in the main study.

Mortality:

1 death :1 female on day 5 at 2002 mg/kg

Clinical signs:

other: Ataxia, hypothermia, watering of the eyes in some animals, paleness of circulatory system, prostration No cutaneous lesions at application site

Gross pathology:

On dead animal: lungs and intestines brown, brown and sticky liquid in bladder, depigmentation of liver
On sacrified animals: kidneys and/or spleen with dark colour, on 5 males and on 4 females.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Not classified for acute toxicity by dermal route.

Executive summary:

In an acute dermal toxicity study (Hazleton, 1986), groups of young adult Sprague-Dawley rats males and females (5/sex) were dermally exposed to p-trifluoromethylaniline (>=98.5%) for 24 hours to lateral-dorsal at doses of  0, 2002 mg/kg mg/kg bw.  Animals then were observed for 14 days.
 
Dermal LD50 Males = >2002 mg/kg bw
      Females = >2002 mg/kg bw
      Combined = >2002 mg/kg bw
P-trifluoromethylaniline is not classified based on the LD50, according to EU criteria (67/548/EC directive) and CLP criteria.