Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: literature data
Adequacy of study:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is considered as reliable with restrictions.

Data source

Reference
Reference Type:
publication
Title:
Toxicologic and pharmacologic studies on acetamide, as an antidote against monofluoroacetamide poisoning: Studies on the selective toxicity. XVII
Author:
Y. Hashimoto et al.
Year:
1970
Bibliographic source:
Pharmacometrics, 4(3), 451-462 (1970)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Name: Acetamide
Molecular weight: 59.07
Melting point: 80 - 82 °C

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
Body weight: about 170 g

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: no data
No. of animals per sex per dose:
24 animals
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
12.9 other: g/kg
Based on:
test mat.
Mortality:
none
Clinical signs:
relaxation of the skeletal muscles, motor paralysis of the hind limbs, stimulation of the respiratory and cardiac frequencies
Body weight:
no data

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 of Acetamide was determined in male rats by Hashimoto et al. Acetamide was shown to be of low toxicity. Large doses of Acetamide produced relaxation of the skeletal muscles, motor paralysis of the hind limbs and stimulation of the respiratory and cardiac frequencies.
The LD50 of Acetamide was determined as 12.9 g/kg body weight.
Executive summary:

The oral LD50 of Acetamide was determined in male rats and mice by Hashimoto et al. Acetamide was shown to be of low toxicity. Large doses of Acetamide produced relaxation of the skeletal muscles, motor paralysis of the hind limbs and stimulation of the respiratory and cardiac frequencies. The LD50 of Acetamide was determined as 12.9 g/kg body weight in the rat and in the mouse.