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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 07.03.1979 to 06.07.1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No data on GLP and no data on guidelines, but the test method is similar to OECD 403.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
Method described in the study report
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl chloroacetate
EC Number:
203-294-0
EC Name:
Ethyl chloroacetate
Cas Number:
105-39-5
Molecular formula:
C4H7ClO2
IUPAC Name:
ethyl 2-chloroacetate
Details on test material:
- Name of test material (as cited in study report): Monochloressigsäureäthylester
- Physical state: transparent colorless liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 199-238 g (average weight 214 g); females: 195-230g (average weight 209 g)
- Housing: In plastic cages with wood chips
- Diet (e.g. ad libitum): Altromin 1324 (from Altromin GmbH in Lage/Lippe), ad libitum after exposition
- Water (e.g. ad libitum): Tap water, ad libitum after exposition

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20,4-23,9 ºC
- Pressure: 997.3-1013.0 mbar

IN-LIFE DATES: From: 07.03.1979 To: 23.05.1979

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindrical plastic cages
- Exposure chamber volume: 60 L
- Source and rate of air: 600 L/h through a calibrated air rotameter.
- System of generating particulates/aerosols: The primary aerosol formation took place in a 10 liter flask. Through a small vertical tube reached
aerosol particles (secondary aerosol) into the inhalation chamber.
- Method of particle size determination: particle number system model Kratel 225 KG, Gerlingen
- Treatment of exhaust air: In the bottom of chamber there is a suction device with cotton and 10% sodium hydroxide solution, treated with 0.5% hydrogen peroxide. Extraction: 800 liters per hour.
- Temperature, humidity, pressure in air chamber: 22.5 °C


During inhalation, animals' behavior was closely observed and recorded.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
0.5, 1.5, 2 and 4.5 mL test substance/ h / m3 air (corresponding to 0.83, 2.5, 3.33 and 7.5 mL test substance/m3 air)
No. of animals per sex per dose:
6 males and 6 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
3.33 other: mL/m3
Exp. duration:
4 h
Mortality:
After exposure to 2 mL/h/0,6 m3 air, 6 rats died (3 females and 3 males), and after exposure to 4.5 mL/h/0, 6 m3 of air, all animals died.
Clinical signs:
other: During and after exposure, the animals showed the following symptoms: increased respiration rate, irregular respiration, gasping breathing, narrowed eye lids, trembling, disturbance of balance, abdominal position, ataxia, passivity, stupor, analgesia and
Body weight:
Average wieghts of groups of dose at 1, 7 and 14 days after exposure:
Group 1 (0,5 mL): Males: 209, 246, 268 g; Females: 213, 210, 211 g
Group 2 (1,5 mL): Males: 196, 214, 232 g; Females: 195, 218, 246 g.
Group 3 (2,0 mL): Males: 186, 206, 243 g; females: 183, 199, 212 g
Group 4 (4,5 mL): No data because all animals died during the first 48 hours.
Gross pathology:
At autopsy of dead animals, studies showed macroscopic lung dark red, with some pockets of dark red to black. By making a cut, a bloody foam could be seen. The autopsy of the animals that were sacrificed at the end of the study showed no significant gross changes.

Any other information on results incl. tables

The 4h LC50 in rats was determined to be 3.33 ml/m3.

Applicant's summary and conclusion

Interpretation of results:
other: see discussion under Acute Toxicity Endpoint Summary
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The 4h LC50 in rats was determined to be 3.33 ml/m3.
Executive summary:

The acute inhalation toxicity of Monochloressigsäureäthylester was tested in rats in an apparatus for spraying dynamically an aerosol.

To determine the LC50, Monochloressigsäureäthylester was used undiluted.

After exposure to 0.5 and 1.5 mL of Monochloressigsäureäthylester/h/0,6 m3 of air all animals survived. After exposure to 2 mL/h/0,6 m3 air, 6 rats died, and after exposure to 4.5 mL/h/0, 6 m3 of air all animals died.

During and after exposure, animals showed the following symptoms: increased respiratory rate, irregular breathing and panting, narrowing of the palpebral fissures, tremor, balance disorder, ataxia, passiveness, drowsiness, analgesia and hyporeflexia. At autopsy of dead animals, studies showed macroscopic lung dark red, with some pockets of dark red to black. By making a cut, we could see a bloody foam. The autopsy of the animals that were sacrificed at the end of the study showed no significant gross changes. The 4h LC50 in rats was determined to be 3.33 ml/m3.