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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:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
publication
Title:
HSDB - Tramadol
Year:
2018
Bibliographic source:
Hazardous Substances Data Bank [Internet]. Bethesda (MD): National Library of Medicine (US). Available from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Tramadol
EC Number:
248-319-6
EC Name:
Tramadol
Cas Number:
27203-92-5
Molecular formula:
C16H25NO2
IUPAC Name:
(1R,2R)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol
Test material form:
solid: particulate/powder

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
270 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

LD50, mouse oral = 270 mg/kg

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
LD50 of tramadol , as determined in mouse by oral route, is 270 mg/kg.