2-chloroacetamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted before GLP application, however it was done according to valid methods, therefore it is considered relevant, reliable and adequate for classification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Method: other: Hoechst AG guideline

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-chloroacetamide

EC Number:

201-174-2

EC Name:

2-chloroacetamide

Cas Number:

79-07-2

Molecular formula:

C2H4ClNO

IUPAC Name:

2-chloroacetamide

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Chloracetamid
- Physical state: white crystalline
- Analytical purity: technical substance grade

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Own breeding (Hoechst)
- Weight at study initiation: 80-110g (average 95g)
- Fasting period before study: 16 hours
- Housing: In polymer cages on wood shavings
- Diet (e.g. ad libitum): Altromin 1324 by Altromin GmbH, Lage/Lippe, Germany,
ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum

IN-LIFE DATES: From: 1976.08.30 To:1976.09.20

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

1% aqueous solution of chloroacetamide used.
Single application by pharyngeal tube.

Doses:

80, 125, 160, 200, 320 mg/kg bw

No. of animals per sex per dose:

10

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, body weight

Statistics:

LD50 was determined by probit analysis (according to LINDER and WEBER), confidence limits were calculated according to CAVALLl-SFORZA.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

138 mg/kg bw

Based on:

test mat.

95% CL:

127 - 149

Mortality:

80 mg/kg bw: 0 of 10 rats; 125 mg/kg bw: 2 of 10 rats;
160 mg/kg bw: 9 of 10 rats; 200 mg/kg bw: 10 of 10 rats;
320 mg/kg bw: 10 of 10 rats.

Clinical signs:

other: Deadly poisoned animals showed impaired balance, gasping breathing and bended posture.

Gross pathology:

No macroscopically effects were observed.

Any other information on results incl. tables

Table 1. Results

Dosis mg/kg	Concentration  in %	Number of dead animals/ number of tested animals
80	1	0/10
125	1	2/10
160	1	9/10
200	1	10/10
320	1	10/10

Applicant's summary and conclusion

Interpretation of results:

moderately toxic

Remarks:

Migrated information Criteria used for interpretation of results: other: W.S.SPECTOR : Handbook of Toxicology

Conclusions:

The acute oral toxicity test in female SPF-Wistar rats resulted in an LD50 of 138 mg/kg bw. Chloracetamid at a single oral application is classified as moderately toxic after W.S. SPECTOR in the “Handbook of Toxicology”.

Executive summary:

Chloracetamid was tested after single oral gavage in female SPF-Wistar rats. Preliminary tests demonstrated higher sensitivity in female animals. The rats were fasted for 16 hours before and 2 hours after application. The animals were observed 14 days after application and weighed weekly. Deadly poisoned animals were dissected and assessed macroscopically; these animals showed impaired balance, gasping breathing and bended posture. After the study period, surviving animals were sacrificed and dissected macroscopically. No macroscopically effects were observed. Chloracetamid had an LD50 of 138 mg/kg bw and is classified as moderately toxic according to W.S. SPECTOR in the “Handbook of Toxicology”.