Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because a study on acute toxicity by the inhalation route is available
other:
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Chloroethane is a gas with an etheral odour.
Physical state at 20°C and 1013 hPa:
gaseous
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April - May 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
fixed concentration procedure
Limit test:
yes
Species:
rat
Strain:
other: F344/N
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories (Portage, MI, USA)
- Age at study initiation: 8-9 weeks
- Housing: individually in stainless steel wire cages (Harford Metal Inc., Aberdeen, MD, USA)
- Diet: NIH 07 rat and mouse ration (Zeigler Bros., Inc., Gardners, PA, USA) available ad libitum during non-exposure periods
- Water: automatic watering system (Edstrom Industries, Waterford, WI, USA), available ad libitum
- Acclimation period: 26 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): exposure: 23.9 - 24.4 °C; non-exposure: 22.2 - 24.4 °C
- Humidity (%): exposure: 55 - 57%; non-exposure: 40 - 60%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: April 1980 To: 12 May 1980
Route of administration:
inhalation: gas
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: vapour generation system; the liquid to be vaporized was forced under pressure, at a metered rate, directly from the shipping container into a stainless steel boiler that was maintained at about 32 °C by a controlled-temperature water bath. The vapour was routed through a gas metering valve and a purge/expose valve into a pipe at the chamber inlet, where the vapour was mixed with dilution air entering the chamber.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
19000 ppm (50130 mg/m³)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed continually during exposure and then 3 times per day for 14 days; weighed initially
- Necropsy of survivors performed: no
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 19 000 ppm
Based on:
test mat.
Exp. duration:
4 h
Mortality:
All rats survived.
Clinical signs:
other: No clinical signs of toxicity were seen.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In the single 4-hour exposure studies, all rats survived at the sole concentration of 19000 ppm chloroethane. No clinical signs of toxicity were seen
Executive summary:

Groups of male and female rats (5/sex) were exposed by whole body inhalation for a single 4-hour exposure to air containing chloroethane at the target concentration of 19000 ppm (National Toxicology Program, 1989). Animals were weighed before exposure and were observed continually during exposure and then three times per day for 14 days. After 14 days, the animals were killed without a formal necropsy. All rats survived the 4-hour exposure to 19000 ppm chloroethane. No clinical signs of toxicity were seen.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion