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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from publication

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
To determine acute oral toxicity of test chemical in mice
Author:
Kazuo Hashimoto et. al.
Year:
1981
Bibliographic source:
Archives of Toxicology
Reference Type:
review article or handbook
Title:
ACUTE ORAL TOXICITY STUDY IN MICE
Author:
Richard J. Lewis
Year:
2012
Bibliographic source:
Sax's Dangerous Properties of Industrial Materials, 12th Edition, 5 Volume Set,2012
Reference Type:
other: Authoritive database
Title:
Acute oral toxicity study of test chemical in mice
Author:
U.S. National Library of Medicine
Year:
2018
Bibliographic source:
Chemidplus Database,U.S. National Library of Medicine,2018
Reference Type:
secondary source
Title:
acute oral toxicity study of test chemical in mice
Author:
RTECS
Year:
2018
Bibliographic source:
RTECS (registry of toxic effect of chemical substance database), 2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The acute toxicity of the test chemical by oral administration in mice was determined according to Weil (1952), using four animals per dosage level and four different doses.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-tert-butylacrylamide
EC Number:
203-505-6
EC Name:
N-tert-butylacrylamide
Cas Number:
107-58-4
Molecular formula:
C7H13NO
IUPAC Name:
N-tert-butylacrylamide
Details on test material:
- Name of test material (IUPAC name): 2-Propenamide, N-(1,1-dimethylethyl)-
- Common name: N-tert-butylacrylamide
- Molecular formula: C7H13NO
- Molecular weight: 127.1857g/mol
- Smiles notation: CC(C)(C)NC(=O)C=C
- InChl: 1S/C7H13NO/c1-5-6(9)8-7(2,3)4/h5H,1H2,2-4H3,(H,8,9)
- Substance type: Organic

Test animals

Species:
mouse
Strain:
other: ddY
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 29 2.2 g body weight
- Housing: Animals were randomly placed in plastic cages (5-7 per cage) containing wooden flakes.
- Diet (e.g. ad libitum): laboratory chow, ad libitum
- Water (e.g. ad libitum): water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
no data
Doses:
5.6 - 9.7 mmol/kg (712.23 - 1233.7 mg/kg bw)
No. of animals per sex per dose:
4 animals per dose
Control animals:
not specified
Details on study design:
no data
Statistics:
The acute toxicity of the test compounds by oral administration in mice was determined according to Weil (1952).

Results and discussion

Preliminary study:
no data
Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
941.174 mg/kg bw
Based on:
test mat.
95% CL:
712.23 - 1 233.7
Remarks on result:
other: 50% mortality was observed
Mortality:
50% Mortality was observed in treated mice at 941.174 mg/kg bw.
Clinical signs:
other: no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The lethal concentration (LD50) value for acute oral toxicity test was considered to be 914.174 mg/kg bw, with 95% confidence limit of 712.23 - 1233.7 mg/kg, when male ddy strain mice were treated with the given test chemical orally.
Executive summary:

Acute oral toxicity study was performed by using the given test chemical in Male mice of ddY strain at the dose concentration of 5.6 - 9.7 mmol/kg (712.23 - 1233.7 mg/kg bw). The given test chemical was dissolved in DMSO and administered via oral route. Animals were 5-6 weeks of age and 29 ± 2.2 g body weight at the beginning of the experiment and were randomly placed in plastic cages (5-7 per cage) containing wooden flakes. They were fed laboratory chow and water ad libitum. The acute toxicity of the test compounds by oral administration in mice was determined according to Weil (1952). 50% Mortality was observed in treated mice at 941.174 mg/kg bw. Therefore, the lethal concentration (LD50) value for acute oral toxicity test was considered to be 914.174 mg/kg bw, with 95% confidence limit of 712.23 - 1233.7 mg/kg, when male ddy strain mice were treated with the given test chemical orally.