Registration Dossier
Registration Dossier
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EC number: 617-116-8 | CAS number: 80573-04-2
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
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline is specified in the report.
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Benzoic acid, 5-[(1E)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2- hydroxy-, disodium salt, dihydrate
- Cas Number:
- 150399-21-6
- Molecular formula:
- C17H13N3O6Na2 . 2H2O
- IUPAC Name:
- Benzoic acid, 5-[(1E)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2- hydroxy-, disodium salt, dihydrate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% methylcellulose or 0.9% NaCl
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 2 g/kg bw
- No. of animals per sex per dose:
- 10 animals per sex per dose
- Control animals:
- not specified
- Details on study design:
- All animals were observed for clinical signs and mortality for 7 days. At the end of the observation period, all animals were sacrificed and subjected to complete necropsy.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality was observed during the test.
- Clinical signs:
- other: No clinical signs were observed during the test.
Applicant's summary and conclusion
- Conclusions:
- The acute oral non-lethal dose in rats was greater than 2000 mg/kg.
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