4-chloro-α,α,α-trifluorotoluene

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-chloro-α,α,α-trifluorotoluene

EC Number:

202-681-1

EC Name:

4-chloro-α,α,α-trifluorotoluene

Cas Number:

98-56-6

Molecular formula:

C7H4ClF3

IUPAC Name:

1-chloro-4-(trifluoromethyl)benzene

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): p-Chlorbenzotrifluorid D
- Substance type: intermediate
- Physical state: Colourless, transparent liquid.
- Analytical purity: 99.1%
- Purity test date: 16.03.1992
- Lot/batch No.: HHDD405
- Expiration date of the lot/batch: December 1994
- Stability under test conditions: 4 years if stored at room temperature
- Storage condition of test material: 20°C

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WISK (SPF71), Hoechst AG, Kastengrund
- Age at study initiation: 8-10 weeks
- Weight at study initiation: males: mean 191 g (range 186-195 g); females: mean 190 g (range 185-194 g).
- Fasting period before study:
- Housing: Macrolon cages Type 4, air-conditioned, with pellet wood floor, housed in groups of 5 animals.
- Diet (e.g. ad libitum): Altromin 1324 rodent food ad libitum
- Water (e.g. ad libitum): ad libitum, tap water in plastic bottles.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50± 20%
- Photoperiod (hrs dark / hrs light): 12 dark, 12 light h

IN-LIFE DATES: From: 1 April 1992 To: 15 April 1992

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

clean air

Details on inhalation exposure:

The dry compressed air arrives in the 2 component nozzle up to the exposure tubes, with a flow of 800 L/h. The test item is injected with a constant speed.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gaschromatography equipped with FID detector

Duration of exposure:

ca. 4 h

Concentrations:

32.03 mg /L air.

No. of animals per sex per dose:

5 per each sex.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: twice a day. Weighing: day 8 and day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 32.03 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality was registered.

Clinical signs:

other: Increase of respiration rate, ataxia, irregular respiration, stupor, ruffled coat, stilted gait, ataxic gait, uncorrodinated gait, prone position, tremors, palpebral fissure narrow, increase of salivation.

Body weight:

Regular increase of bw in both male and female animals.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Based on this study results, the test item LC50 is > 32.03 mg/L air, after a 4 hours exposure. The test item results practically non toxic to rats.

Executive summary:

Ten animals, 5 males and 5 females, were exposed to a nose-only inhalation treatment at a concentration of 32.03 mg/L air of p-Chlorbenzotrifluoride, for 4 hours. Clinical signs, body weights and mortality was observed and registered up to a post-exposure observation period of 14 days. No mortality was observed. The reported clinical signs comprised: increase of respiration rate, ataxia, irregular respiration, stupor, ruffled coat, stilted gait, ataxic gait, uncorrodinated gait, prone position, tremors, palpebral fissure narrow, increase of salivation. These clinical signs were fully reversible within 5 days. The body weight gain was regular. Based on this study ' results, the test item LC50 is > 32.03 mg/L air, after a 4 hours exposure. The test item results practically non toxic to rats.