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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
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 authoritative database

Data source

Referenceopen allclose all

Reference Type:
other: authoritative database
Title:
Acute oral toxicity of test chemical in rats
Author:
U.S. National Library of Medicine
Year:
2017
Bibliographic source:
ChemIDplus, A TOXNET DATABASE, Lite Browse Advanced, 2017
Reference Type:
publication
Title:
Acute oral toxiciry study in rats
Author:
Ronald et al.
Year:
1984
Bibliographic source:
Toxicology and Applied Pharmacology

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity of test chemical in rats
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Melamine
EC Number:
203-615-4
EC Name:
Melamine
Cas Number:
108-78-1
Molecular formula:
C3H6N6
IUPAC Name:
1,3,5-Triazine-2,4,6(1H,3H,5H)-triimine
Details on test material:
- IUPAC Name: Melamine
- InChI: 1S/C3H6N6/c4-1-7-2(5)9-3(6)8-1/h(H6,4,5,6,7,8,9)
- Smiles: c1(nc(nc(n1)N)N)N
- Molecular formula :C3H6N6
- Molecular weight :126.122 g/mole
- Substance type:Organic

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Frederick Cancer Research Center (Frederick, Md.)
- Age at study initiation: 10-week-old rats

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
not specified
Doses:
Range from 2150 to 10,000 mg/kg bw
No. of animals per sex per dose:
groups of 5 male and 5 female
Control animals:
not specified
Details on study design:
not specified
Statistics:
LD50 values were determined by probit analysis (Finney, 1964)

Results and discussion

Preliminary study:
not specified
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
3 161 mg/kg bw
Based on:
test mat.
95% CL:
1 344 - 4 722
Remarks on result:
other: 50% mortality observed
Sex:
female
Dose descriptor:
LD50
Effect level:
3 828 mg/kg bw
Based on:
test mat.
95% CL:
2 787 - 5 255
Remarks on result:
other: 50% mortality observed
Mortality:
50% mortality observed at 3161 mg/kg bw in male rats and 3828 mg/kg bw in female rats.
Clinical signs:
other: not specified
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute oral toxicity dose (LD50) was considered to be 3161 mg/kg bw, with 95% confidence limit of 1344-4722 mg/kg bw in male rats and 3828 mg/kg bw, with 95% confidence limit of 2787-5255 mg/kg bw in female rats, when groups of 5 male and 5 female Fischer 344 rats were treated with test chemical via oral gavage route.
Executive summary:

The acute oral toxicity study was conducted by using test chemical in groups of 5 male and 5 female Fischer 344 rats at the dose concentration range from 2150 to 10,000 mg/kg bw. The given test chemical was dissolved in corn oil and administered via oral gavage route.Five dose levels of test chemical were included in each study. LD50 values were determined by probit analysis (Finney, 1964) and were based on deaths occurring within 14 days after administration. 50% mortality observed at 3161 mg/kg bw in male rats and 3828 mg/kg bw in female rats. Therefore, LD50 was considered to be 3161 mg/kg bw, with 95% confidence limit of 1344-4722 mg/kg bw in male rats and 3828 mg/kg bw, with 95% confidence limit of 2787-5255 mg/kg bw in female rats, when groups of 5 male and 5 female Fischer 344 rats were treated with test chemical via oral gavage route.