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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Deadly poisoned animals showed impaired balance, gasping breathing and bended posture.
Body weight:
No effects reported.
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”.