National Toxicology Program

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 (9CI)
• RITALIN
• RITALIN HYDROCHLORIDE

Known Uses:

CENTRAL STIMULANT

Short-Term Toxicity

• 14-Day (Dosed-Feed)  (C56280A) Completed 
  • NTIS No. PB96-162615
    Citation: Toxicology and Carcinogenesis Studies of Methylphenidate Hydrochloride (CAS No. 298-59-9) in F344/N Rats and B6C3F1 Mice (Feed Studies)
  • Rats: F344/N; Mice: B6C3F1
• 13-Week (Dosed-Feed)  (C56280A) Completed 
  • NTIS No. PB96-162615
    Citation: Toxicology and Carcinogenesis Studies of Methylphenidate Hydrochloride (CAS No. 298-59-9) in F344/N Rats and B6C3F1 Mice (Feed Studies)
  • Rats: F344/N; Mice: B6C3F1
  • Dose: 0,125,2000 PPM/10 PER GROUP

Long-Term Carcinogenicity

• 2-YEAR (Dosed-Feed)  (C56280B) Report Complete 
  • TR-439 (NTIS No. PB96-162615)  (Peer Review 06/22/1993)
    Toxicology and Carcinogenesis Studies of Methylphenidate Hydrochloride (CAS No. 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

• In Vitro Cytogenetics (CA/SCE)  (597775) Completed 
  • Chromosome Aberation Positive 
  • Sister Chromatid Exchange Negative 
• 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
  • Chromosome Aberation Positive 
  • Sister Chromatid Exchange Positive 
• Micronucleus  (A56806) Completed 
  • Mice: Tg.AC (FVB/N) Hemizygous
  • Male Negative 
  • Female Negative 
• Micronucleus  (F66268) Completed 
  • Rats
  • 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

• >120 DAYS Continuous Breeding (Dosed-Feed)  (RACB88060) Completed 
  • NTIS No. PB89-178057
    Citation: Methylphenidate Hydrochloride: Reproduction and Fertility Assessment in Swiss CD-1 Mice When Administered Via Feed
  • M/F Mice: Swiss
  • Dose: N/A; 0,.012,.05,.1%; N/A; N/A