Reaction mass of methyl chloroacetate and chloroacetic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 01.03.1979 to 29.05.1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test method similar to OECD guideline 401. No GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Method: Internal procedure valid at the time of study.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Monochloressigsäure
- Physical state: white crystalline flakes

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Own breeding
- Strain: Hoe WISKf (SPF71)
- Weight at study initiation: 162 - 176 g (x = 169 g, s = ± 4.51 g, n = 40).
- Fasting period before study: No food supplied from 16 h prior to administration until 2 h post administration.
- Housing: Animals were housed in groups in plastic cages.
- Diet (e.g. ad libitum): Altromin 1324 (Altromin GmbH, Lage/Lippe, Germany, ad libitum.
- Water (e.g. ad libitum): Tap water, ad libitum.
The test was performed in female rats, because in preliminary tests, a higher sensitivity could be determined.

IN-LIFE DATES: From: 01.03.1979 To: 29/03/1979.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Stock solution: 1% solution in deionized water (1 g/100 mL).

Doses:

40, 63, 100, 160 mg/kg bw

No. of animals per sex per dose:

10 female rats per group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: The symptoms of toxicity, the mortality rate and the death time were recorded.

Statistics:

LD 50 determined by Probit analysis (method acc to Linder and Weber); confidence limits calculated according to Fieller (company software).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

90.4 mg/kg bw

95% CL:

73.6 - 112

Mortality:

Animals died between 128 minutes and 24 hours after the administration.

Clinical signs:

In dead animals, the following clinical signs were observed: motor restlessness, squat position, hair-raising, balance disorder, prone position, passivity, drowsiness, dilated eyes, increased lacrimation and intermittent respiration.

Gross pathology:

Dead animals during the study: livers red-brown, intensively supplied with blood; lungs slightly red to pink; black spleen near stomach joining points
Surviving animals: without macroscopic findings.

Any other information on results incl. tables

Table 07.02.01_01. Mortality rate

Dose (mg/kg bw)	Concentration (%)	Dead animals/ Used animals
40	1	0/10
63	1	2/10
100	1	5/10
160	1	10/10

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

At the end of an observation period of 14 days a LD 50 of 90.4 (73.6 - 112) mg/kg body weight was determined by Probit.

Executive summary:

The study of acute oral toxicity of monochloroacetic acid was performed on female Wistar rats. Test method was similar to OECD guideline 401. A single oral dose of test substance was administered by gavage to ten animals per dose. Four dose levels were tested: 40, 63, 100 and 160 mg/kg bw. At the end of an observation period of 14 days a LD 50 of 90.4 (73.6 - 112) mg/kg body weight was determined by Probit.