Ethyl chloroacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 27.03.1979 to 29.05.1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No data on guidelines and no GLP, but the test method is similar to OECD 402.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

No guideline was followed but the test method is similar to OECD 402.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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: clear colorless liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 182 g ± 7.93 g
- Housing: In individual cages
- Diet (e.g. ad libitum): Altromin 1324 (Altromin GmbH, Lage/Lipe); ad libitum
- Water (e.g. ad libitum): ad libitum; tap water

IN-LIFE DATES: From: 27.03.1979 To: 23.04.1979

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: about 30 cm2
- Type of wrap if used: the treatment area was covered with aluminum foil (6 x 8 cm) and again by a wide elastic plaster bandage (Elastoplast, fixed 8 cm) around the body of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated area was washed with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration (if solution): Undiluted
- Constant volume or concentration used: no

Duration of exposure:

24 hours

Doses:

63, 100, 125, 160 and 250 mg/kg bw

No. of animals per sex per dose:

6 females per dose, except in the highest dose, with 12 females.

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After dermal application, symptoms of poisoning, mortality rate and timing of deaths were recorded. For 14 days, the animals were weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Fatally intoxicated animals were dissected and macroscopically examined at autopsy. The surviving animals were euthanized with CO2 gas, dissected and also macroscopically examined.

Statistics:

The LD 50 was calculated using Probit (method according to Linder and Weber). The confidence limits were calculated according to Cavalli-Sforza (Department of Applied Mathematics of Hoechst).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

161.2 mg/kg bw

95% CL:

129.2 - 201.1

Mortality:

In the dose groups of 63 and 100 mg/kg no mortalities were observed. In the dose group of 125 mg/kg there were 2 (of 6) deaths. In the group of 160 mg/kg, 5 (of 6) animals died, and in the highest dose group 9 (of 12). All animals died between 147 minutes and 9 days post exposure.

Clinical signs:

other: Animals that died during the study had the following clinical symptoms: restlessness, abdominal position, passivity, stupor, rufflef fur, narrowed eye lids and increased lacrimation. The surviving animals recovered from the symptoms within 24-48 hours af

Gross pathology:

The autopsy of the animals that were fatally poisoned showed: lungs brownish red and blotchy, liver intense and dark blood color. In some animals, bladder and rectum were filled with a dark brown-black liquid with signs of autolyse.
In animals sacrificed at the end of the study, macroscopic studies were normal, without any visible alterations.

Any other information on results incl. tables

Table 07.02.03_01. Mortality

Dose (mg/kg bw)	Concentration	Mortality rate (death animals/ treated animals)
63	Undiluted	0/6
100	Undiluted	0/6
125	Undiluted	2/6
160	Undiluted	5/6
250	Undiluted	9/12

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category II

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD 50 was 161.2 (129.2 - 201.1) mg/kg body weight.

Executive summary:

A study of the acute dermal toxicity was performed on female Wistar rats. At the end of an observation period of 14 days, a LD 50 of 161.2 (129.2 - 201.1) mg/kg body weight was determined by Probit.