Registration Dossier
Registration Dossier
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EC number: 456-160-0 | CAS number: 73942-87-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP. Guideline study
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 456-160-0
- EC Name:
- -
- Cas Number:
- 73942-87-7
- Molecular formula:
- C12H13NO3
- IUPAC Name:
- 7,8-dimethoxy-2,3-dihydro-1H-3-benzazepin-2-one
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Solution 0,5% methylcellulose
- Doses:
- 2000 mg/Kg
- No. of animals per sex per dose:
- 3 males and 3 females
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 3 rats; Number of deaths: 0 and Fame: 3 rats; Number of deaths: 0
- Clinical signs:
- other: At de 2000 mg/Kg dose-level, no deaths occurred during the study. Signs of dyspnea (females) were the clinical signs observed in the whole of the animals on day 1 of the study. No more clinical signs persisted on day 2, until the end of the study.
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions, the oral LD50 of the test item Veralactame is higher than 2000 mg/kg in rats.
According to the classification criteria laid down in Council Directive REACH 2006/121/CE (and subsequent adaptation) on the appoximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, and concerning the potencial toxicity by oral route, the test item Veralactame should not be classified.
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