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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
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 authenticated source

Data source

Referenceopen allclose all

Reference Type:
other: Secondary source
Title:
Acute oral toxicity study of the test chemical
Author:
U. S. National Library of Medicine
Year:
2019
Bibliographic source:
Chemid Plus
Reference Type:
other: RTECS
Title:
Acute oral toxicity study of the test chemical
Author:
Centers for Disease Control and Prevention
Year:
2019
Bibliographic source:
RTECS

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Acute oral toxicity study of the test chemical using rats
GLP compliance:
not specified
Test type:
other: Not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): D & C yellow no 10
- Molecular formula (if other than submission substance): C18-H9-N-O8-S2.2Na
- Molecular weight (if other than submission substance): 477.3801 g/mol
- Substance type: Organic
- Physical state: No data available
- Purity: certified total colour content 90%
- Impurities (identity and concentrations): No data available

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
2000 mg/kg
No. of animals per sex per dose:
No data
Control animals:
not specified
Details on study design:
- Other examinations performed: Mortality
Statistics:
No data

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality
Mortality:
50% mortality was noted at 2000 mg/Kg
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute oral median lethal dose (LD50) for the test chemical using rats is considered to be 2000 mg/Kg.
Executive summary:

Acute oral toxicity study was performed to determine the toxic nature of the test chemical. The study was performed using rats at dose level of 2000 mg/Kg. 50% mortality was observed at 2000 mg/Kg. Based on the details available, the acute oral median lethal dose (LD50) for the test chemical using rats is considered to be 2000 mg/Kg.