Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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.