Registration Dossier
Registration Dossier
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EC number: 305-897-5 | CAS number: 95193-83-2
Acute Toxicity: oral
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:
- 2 019
- 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:
- 2 019
- Bibliographic source:
- RTECS
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- 8004-92-0
- Cas Number:
- 8004-92-0
- IUPAC Name:
- 8004-92-0
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system 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:
- other: 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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