Registration Dossier
Registration Dossier
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EC number: 200-607-2 | CAS number: 65-31-6
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 Authoritative database
Data source
Referenceopen allclose all
- Reference Type:
- other: authoritative database.
- Title:
- Acute oral toxicity - test chemical
- Author:
- U.S. National Library of Medicine
- Year:
- 2 017
- Bibliographic source:
- ChemIDplus
- Reference Type:
- other: Authoritive database
- Title:
- Acute oral toxicity study in rat
- Author:
- IFA GESTIS
- Year:
- 2 017
- Bibliographic source:
- GESTIS SUBSTANCE Database
- Reference Type:
- other: authoritative database
- Title:
- Acute Toxicity studies conducted on rodents
- Author:
- U.S. National Library of Medicine
- Year:
- 2 018
- Bibliographic source:
- HSDB
- Reference Type:
- review article or handbook
- Title:
- Acute oral toxicity study of test chemical in rat
- Author:
- Richard J. Lewis
- Year:
- 2 012
- Bibliographic source:
- Sax's Dangerous Properties of Industrial Materials
- Reference Type:
- review article or handbook
- Title:
- Toxicity to aquatic algae and cyanobacteria.
- Author:
- S. Gangolli
- Year:
- 1 999
- Bibliographic source:
- Dictionary of substances and their effects S. Gangolli 1999
- Reference Type:
- secondary source
- Title:
- Acute toxicity test in rat
- Author:
- RTECS
- Year:
- 2 018
- Bibliographic source:
- RTECS (Registry of Toxic Effects of Chemical Substances),2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity study of test chemical was performed in rats.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- Nicotine dihydrogen ditartrate
- EC Number:
- 200-607-2
- EC Name:
- Nicotine dihydrogen ditartrate
- Cas Number:
- 65-31-6
- Molecular formula:
- C10-H14-N2.2C4-H6-O6
- IUPAC Name:
- nicotine dihydrogen ditartrate
- Details on test material:
- - Name of test material (IUPAC name): nicotine dihydrogen ditartrate
- Common name: Nicotine tartrate
- Molecular formula: C10H14N2.2C4H6O6
- Molecular weight: 462.4054 g/mol
- Smiles notation: CN1CCC[C@H]1c2cccnc2.O[C@H]([C@@H](O)C(=O)O)C(=O)O.O[C@H]([C@@H](O)C(=O)O)C(=O)O
- InChl: 1S/C10H14N2.2C4H6O6/c1-12-7-3-5-10(12)9-4-2-6-11-8-9;2*5-1(3(7)8)2(6)4(9)10/h2,4,6,8,10H,3,5,7H2,1H3;2*1-2,5-6H,(H,7,8)(H,9,10)/t10-;2*1-,2-/m011/s1
- Substance type: Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Doses:
- 65 mg/kg bw
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 65 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed
- Mortality:
- 50% mortality was observed at 65 mg/kg bw.
- Clinical signs:
- other: not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The lethal concentration (LD50) value for acute oral toxicity test was considered to be 65 mg/kg bw, when rats were treated with the given test chemical orally.
- Executive summary:
Acute oral toxicity study was performed in rats using the given test chemical at the dose concentration of 65 mg/kg bw.
Animals were observed for mortality. 50% mortality was observed at dose 65 mg/kg bw.
Hence, the LD50 value was considered to be 65 mg/kg bw, when rats were treated with the given test chemical orally.
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