Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Data is from study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Acute inhalation toxicity of test chemical in Wistar rats.
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: 2, 2, 2-trichloro-1-phenylethyl acetate
- Molecular formula: C10H9Cl3O2
- Molecular weight: 267.54
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Age : 7 to 9 weeks
Sex : Male and Female
Body weight range : 200 ±20g
Identification : By cage tag and corresponding colour body marking
Acclimatization : Twenty healthy albino rats were selected and acclimatized for standard laboratory condition for period of one week in experimental room under veterinary examination.
Randomization :After acclimatization and veterinary examination all the selected rats randomly divided into two groups of five females and five males.
Nutritional conditions :For feeding conventional Laboratory diets may be used with an unlimited supply of drinking water.

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: Distilled water
Details on inhalation exposure:
All exposure was conducted in a dynamic nose-only cylindrical chamber built from stainless steel and glass. The chamber had a volume of 8 liters with inner and outer chamber to minimize the fluctuation in concentration and temperature. All the animals uniformly exposed to aerosol drug concentration.
For the inhalation purpose the rats were placed in polycarbonate holder tubes positioned radically around exposure chamber, so that only the snouts and nostrils of the animals were exposed to the aerosol. The chamber was maintained at a slightly negative pressure to prevent leakage of the test atmosphere from the system, as well as its dilution with outside air. The exhaust air was decontaminated by subsequent passage through 1% NaOH solution, silica gel and activated charcoal filters.
Duration of exposure:
6 h
No. of animals per sex per dose:
10 (5 males and 5 females)
Control animals:
not specified
Details on study design:
Ten healthy wistar albino rats of both sex body weight 200±20 gm were selected for study after acclimatization. The test groups of animals were exposed to aerosol at the concentration of 5 mg/L for period of 4 hrs. After exposure all the animals were closely observed for clinical signs of toxicity at various internals such as 1 hr, 2 hrs, 4 hrs, and 6 hrs on the day of test compound aerosol exposure and later on twice a day throughout the experimentation period of 14 days. The necropsy was performed on all the animals at termination of experiment.
All the albino rats exposed to aerosol at the concentration of 5 mg/L did not show any clinical signs of intoxication. Furthermore, no mortality was observed throughout the period of observation.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 mg/L air
Based on:
dissolved
Exp. duration:
6 h
Mortality:
The test compound did not elicit any mortality at test concentration viz, 5.0 mg/L throughout the period of observation after exposure.
Clinical signs:
The test compound did not elicit any clinical signs of intoxication at the tested aerosol concentration of 5 mg/L observed for the period of 14 days.
Body weight:
The body weight of animals exposed to test compound, observed on day 0th (pre treatment) and day 7th (post treatment) did not differ significantly as compared to day 0th. Whereas, body weight of animals observed on day 14th showed slight increase as compared to day 0 and 7th.
Gross pathology:
Necropsy-:
Necropsy was carried out on all the animals that died during the study or surviving animals were sacrificed at the end of the study to observe any gross pathological changes.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute lethal Concentration (LC50) of test chemical in wister albino rats was found to be more than 5 mg/L (>5 mg/L).
Acute toxicity of test chemical to rat by inhalation route indicates that the substance exhibits acute toxicity by the inhalation route in the Category 4 which is relatively non toxic.
Executive summary:

The acute inhalation study of test compound was conducted in albino rat under the OECD-Guideline -403 for testing of chemicals. In limit test, ten healthy wistar albino rats of body weight 200±20 gm were selected for study after acclimatization. The test group of animals was exposed to aerosol at the concentration of 5 mg/L for period of 4 hrs. After exposure all the animals were closely observed for clinical signs of toxicity at various internals such as 1 hr, 2 hrs, 4 hrs, and 6 hrs on the day of test compound aerosol exposure and later on twice a day throughout the experimentation period of 14 days. The necropsy was performed on all the animals at termination of experiment. All the albino rats exposed to aerosol at the concentration of 5 mg/L did not show any clinical signs of intoxication. Furthermore, no mortality was observed throughout the period of observation. The necropsy was performed on all the animals at the termination of study did not show any gross pathological changes. In confirmatory test, after 72 hrs, the result obtained from limit test was confirmed in another 10 animal of both sex at similar concentration following same guideline. Ten healthy wistar albino rats of both sex body weight 200±20 gm were selected for study after acclimatization. The test groups of animals were exposed to aerosol at the concentration of 5 mg/L for period of 4 hrs. After exposure all the animals were closely observed for clinical signs of toxicity at various internals such as 1 hr, 2 hrs, 4 hrs, and 6 hrs on the day of test compound aerosol exposure and later on twice a day throughout the experimentation period of 14 days. The necropsy was performed on all the animals at termination of experiment. All the albino rats exposed to aerosol at the concentration of 5 mg/L did not show any clinical signs of intoxication. Furthermore, no mortality was observed throughout the period of observation. The body weight of animals exposed to test compound, observed on day 0th (pre treatment) and day 7th (post treatment) did not differ significantly as compared to day 0th. Whereas, body weight of animals observed on day 14th showed slight increase as compared to day 0 and 7th. The necropsy was performed on all the animals at the termination of study did not show any gross pathological changes. Hence, the acute lethal Concentration (LC50) of test compound in wister albino rats was considered to be >5 mg/L. The result obtained from present investigation can be concluded that test compound test chemical is acutely non toxic to wistar albino rats.