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Toxicological information

Acute Toxicity: oral

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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:
2017
Bibliographic source:
ChemIDplus
Reference Type:
other: Authoritive database
Title:
Acute oral toxicity study in rat
Author:
IFA GESTIS
Year:
2017
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:
2018
Bibliographic source:
HSDB
Reference Type:
review article or handbook
Title:
Acute oral toxicity study of test chemical in rat
Author:
Richard J. Lewis
Year:
2012
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:
1999
Bibliographic source:
Dictionary of substances and their effects S. Gangolli 1999
Reference Type:
secondary source
Title:
Acute toxicity test in rat
Author:
RTECS
Year:
2018
Bibliographic source:
RTECS (Registry of Toxic Effects of Chemical Substances),2018

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals 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:
not specified
Body weight:
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.