Registration Dossier
Registration Dossier
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EC number: 219-823-3 | CAS number: 2544-13-0
Carcinogenicity
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:
- 2 013
- 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 substance name:
- Methyldopa
- EC Number:
- 209-089-2
- EC Name:
- Methyldopa
- Cas Number:
- 555-30-6
- IUPAC Name:
- 3-hydroxy-alpha-methyl-L-tyrosine
Constituent 1
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).
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