National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/ts-10266-r

Testing Status of Methylphenidate hydrochloride - 10266-R

 

CASRN: 298-59-9

Related: METHYLPHENIDATE, CAS 113-45-1, NTPNO M20344

Formula: C14-H19-N-O2.Cl-H

Synonyms/Common Names

  • 2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride
  • Ritalin
  • Ritalin hydrochloride

Known Uses

Central stimulant. Used in the treatment of narcolepsy and attention deficit hyperactivity disorders.

Chemical Properties

Toxicity Effects (HSDB)

Short-Term Toxicity

  • 14-Day (Dosed-Feed)  (C56280A)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 13-Week (Dosed-Feed)  (C56280A)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: 0,125,2000 PPM/10 PER GROUP.

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C56280B)  Report Complete 
    • TR-439 (NIH Number: 95-3355)  (Peer Review Approval 06/22/1993A )
      Toxicology and Carcinogenesis Studies of Methylphenidate Hydrochloride (CASRN 298-59-9) in F344/N Rats and B6C3F1 Mice (Feed Studies)
    • Rats: F344/N; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats No Evidence 
      • Female Rats No Evidence 
      • Male Mice Some Evidence 
      • Female Mice Some Evidence 
    • Dose: R: 0, 100, 500, OR 1000 PPM M: 0, 50, 250, OR 500 PPM; 50 PER GROUP.

Genetic Toxicology

  • Comet Assay  (F66268B)  Completed 
    • Rats
  • In Vitro Cytogenetics (CA/SCE)  (597775)  Completed 
    • Sister Chromatid Exchange Negative 
    • Chromosome Aberrations Positive 
  • In Vitro Cytogenetics (CA/SCE)  (864605)  Completed 
    • Citation: Galloway, S., Armstrong, M., Reuben, C., Colman, S., Brown, B., Cannon, C., Bloom, A., Nakamura, F., Ahmed, M., Duk, S., Rimpo, J., Margolin, B., Resnick, M., Anderson, B., and Zeiger, E. Chromosome aberration and sister chromatid exchanges in Chinese hamster ovary cells: Evaluations of 108 chemicals. Environ. Molec. Mutagen. Vol. 10 (Suppl 10) (1987) 1-176
    • Sister Chromatid Exchange Positive 
    • Chromosome Aberrations Positive 
  • Micronucleus  (A56806)  Completed 
    • Mice: Tg.AC (FVB/N) Hemizygous
    • Male Negative 
    • Female Negative 
  • Micronucleus  (F66268)  Completed 
    • Rats: Wistar Han
    • Male Negative 
  • Salmonella  (214507)  Completed 
    • Citation: Mortelmans, K., Haworth, S., Lawlor, T., Speck, W., Tainer, B., and Zeiger, E. Salmonella mutagenicity tests. II. Results from the testing of 270 chemicals Environ. Mutagen. Vol. 8 (Suppl 7) (1986) 1-119
    •  Negative 
  • Salmonella  (501412)  Completed 
    • Citation: Mortelmans, K., Haworth, S., Lawlor, T., Speck, W., Tainer, B., and Zeiger, E. Salmonella mutagenicity tests. II. Results from the testing of 270 chemicals Environ. Mutagen. Vol. 8 (Suppl 7) (1986) 1-119
    •  Negative 

Organ Systems Toxicity

  • greater than 120 days Continuous Breeding (Legacy) (Dosed-Feed)  (RACB88060)  Completed 
    • Citation: Methylphenidate Hydrochloride: Reproduction and Fertility Assessment in Swiss CD-1 Mice When Administered Via Feed
    • Male and Female Mice: Swiss
    • Dose: N/A; 0,.012,.05,.1%; N/A; N/A.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.