Registration Dossier

Administrative data

Endpoint:
carcinogenicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
secondary source
Title:
No information
Year:
2013
Bibliographic source:
Daily Med Current Medication Information

Materials and methods

Principles of method if other than guideline:
Method not published
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: mouse and rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Duration of treatment / exposure:
two years
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
up to 1800 mg/kg/day
Basis:
no data
to mice
Remarks:
Doses / Concentrations:
up to 240 mg/kg/day
Basis:
no data
to rats

Results and discussion

Applicant's summary and conclusion

Conclusions:
No evidence of a tumorigenic effect was seen when methyldopa was given for two years to mice at doses up to 1800 mg/kg/day or to rats at doses up to 240 mg/kg/day (30 and 4 times the maximum recommended human dose in mice and rats, respectively, when compared on the basis of body weight; 2.5 and 0.6 times the maximum recommended human dose in mice and rats, respectively, when compared on the basis of body surface area; calculations assume a patient weight of 50 kg).