Registration Dossier

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:
other: GLP, in accordance with guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
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.