Registration Dossier
Registration Dossier
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EC number: 456-160-0 | CAS number: 73942-87-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
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
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: 0,5% METHYLCELLULOSE
- Duration of exposure:
- 24 h
- No. of animals per sex per dose:
- Three animals of one sex were used for each step. Males were used in the initial step. The dose-level used as the starting dose was selected from one of three fixed levels, 25, 200 or 2000 mg/kg body weight.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 other: mg/kg
Any other information on results incl. tables
Mortality: Male: 5 rats; Number of deaths: 0
Fame: 5 rats; Number of deaths: 0
Clinical signs: No clinical signs and no cutaneous reactions were observe during 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 clasification 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 dermal route, the test item Veralactame should not be clasified.
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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