Reaction mass of methyl chloroacetate and chloroacetic acid

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From 01.03.1979 to 29.05.1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Internal guideline used, valid at the time of study. No GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

Internal guideline used, valid at the time of study.
The acute subcutaneous toxicity of monochloroacetic acid was studied on female Wistar rats. The doses tested were 80, 100, 125, 200 and 315 mg/kg bw (10 female rats per dose level).

GLP compliance:

no

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
- Analytical purity: released by quality control
- Lot/batch No.: VA 2308

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Raised by Hoechst AG, own breeding.
- Weight at study initiation: 122-188 g; mean: 160 ± 19 g; n=50.
- Housing: Animals were housed in groups in plastic cages on wood shavings.
- Diet (e.g. ad libitum): Altromin 1324 (Altromin GmbH, Lage / Lippe), ad libitum.
- Water (e.g. ad libitum): Tap water, ad libitum.

IN-LIFE DATES: From: 01.03.1979 to 29.05.1979

Administration / exposure

Route of administration:

subcutaneous

Vehicle:

physiological saline

Details on exposure:

50% solutions in 0.9% saline (50 g MCA/ 100 mL saline.
It was given a single injection under the neck skin with different volumes (different doses).

Doses:

80, 100, 125, 200 and 315 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: Within the observation period, animals were weighed weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Toxicity symptoms, mortality rate and time of death were recorded.

Statistics:

LD50 calculation was based on probit analysis. Method acc. to Linder & Weber; confidence limits acc to Cavalli-Sforza.
Calculation program by Hoechst AG, department for Practical Mathematics.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

97.4 mg/kg bw

95% CL:

89.9 - 105.5

Any other information on results incl. tables

Table 07.02.04_01. Mortality rate.

Dose (mg/kg bw)	Concentration %	Number of dead animals / animals used
80	50	1/10
100	50	5/10
125	50	10/10
200	50	10/10
315	50	10/10

Applicant's summary and conclusion

Conclusions:

A LD 50 of 97.4 mg/kg bw (89.9 - 105.5 mg/kg bw) was determined by Probit analysis.

Executive summary:

The acute subcutaneous toxicity of monochloroacetic acid was studied on female Wistar rats. The doses tested were 80, 100, 125, 200 and 315 mg/kg bw (10 female rats per dose level).

At the end of an observation period of 14 days, it was determined an LD 50 of 97.4 mg/kg bw (89.9 - 105.5 mg/kg bw) by Probit analysis.