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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 21.02.1979 to 29.05.1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No data on guidelines but the test method is similar to OECD 401.

Data source

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

Materials and methods

Principles of method if other than guideline:
The examination of acute oral toxicity was performed on female Wistar rats with an observation period of 14 days
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): Monoehloressigsaureathylester
- Physical state: 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: 160-182 g (172 g ± 6,08 g; n=40)
- Fasting period before study: 16 hours
- Housing: Housing of the animals was carried o ut in groups in plastic cages with wood shavings.
- Diet (e.g. ad libitum): No feeding during 2 first hours post administration. During the test period of 14 days after administration, animals were feed ad libitum. Maintenance diet: Altromin 1324 (Altromin GmbH, Lage/Lipe).
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS: No data

IN-LIFE DATES: From: 21.02.1979 To: 14.03.1979

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5g/100 mL
Doses:
80, 125, 200 and 315 mg/kg bodyweight
No. of animals per sex per dose:
10 female rats per dose (The study was performed on female rats because preliminary experiments demonstrated that they were more sensitive to toxicity)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs of poisoning and body weight. Fatally poisoned animals were dissected and the macroscopic autopsy findings were recorded.
Statistics:
The LD 50 was calculated using Probit (method according to Linder and Weber). The confidence limits were calculated according to CAVALLI-SFORZA(programmed by Department of Applied Mathematics of Hoechst Aktiengesellschaft).

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
180 mg/kg bw
95% CL:
150.57 - 215.27
Mortality:
Mortality rate and death time of each animal were recorded.
Fatally poisoned animals died between 136 minutes and 24 hours post-administration with following clinical signs: squatting position, ruffled fur, disturbance of balance, abdominal position and passivity.
Clinical signs:
other: Surviving animals showed same symptoms in an attenuated form, and were free of symptoms 48 hours post administration. Animal behavior was normal throughout the study period.
Gross pathology:
The autopsy of all animals (dead during the study and euthanased) showed no signs of macroscopic alterations.

Any other information on results incl. tables

Table 07.02.02_01. Mortality

Dose  Concentration  Number of death animals / 
(mg/kg)  (%) Number of used animals 
80  0/10 
125   2/10
200  5/10 
315  10/10 

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral media lethal dose (LD 50) in female rats is 180 mg/kg body weight. The confidence interval for p=0.05 is 151 - 215 mg/kg body weight.
Executive summary:
The examination of acute oral toxicity was performed on female Wistar rats by oral gavage at the doses 80, 125, 200 and 315 mg/kg bodyweight. At the end of an observation period of 14 days a LD 50 of 180 (151 - 215) mg/kg body weight was determined by Probit.