Registration Dossier
Registration Dossier
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EC number: 200-471-4 | CAS number: 60-34-4
Carcinogenicity
Administrative data
Description of key information
The registered substance is subject of a harmonized classification as Carc 1B/H350. This is confirmed by experimental data showing tumour formation at various sites in two strains of mice and in hamsters.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LOAEL
- 8.8 mg/kg bw/day
Carcinogenicity: via inhalation route
Endpoint conclusion
- Dose descriptor:
- NOAEC
- 0.038 mg/m³
Justification for classification or non-classification
The registered substance is subject of a harmonized classification as Carc 1B/H350.
Additional information
Key dose-levels and target organs have been compiled from following secondary citation sources:
- CPDB (http://potency.berkeley.edu/chempages/METHYLHYDRAZINE.html);
- HSDB and TOXNET;
- US EPA's AEGL documents (http://www.epa.gov/oppt/aegl/pubs/tsd4.pdf);
- OEHHA's derivation of NSRL (http://www.oehha.org/prop65/law/pdf_zip/MethylhydrazineNSRL.pdf) - NB: their recalculated dose-levels were considered more reliable in case of discordance with other sources
Precisions on organs and tumor types observed:
Hamster, oral (drinking water):
- liver: malignant histiocytoma (M+F)
- cecum: various tumours (M+F)
Hamster, inhalative (sex not indicated):
- nasal polyps and adenomas
- benign adrenal adenomas
Mouse, oral (drinking water):
- liver: various tumours (M) or hepatoma (F)
- bile duct: various tumours (M+F)
- lung: various tumours (F)
Mouse, inhalative (sex not indicated):
- lung tumours, nasal adenoma, nasal polyp, nasal osteoma,
- hemangioma,
- liver adenoma and carcinoma
Dog and Rat, inhalative (M+F): negative but exposure only lasted 1 year
Key carcinogenicity endpoints:
- LOAEL oral (drinking water), lifetime= 22 (M) - 28 (F) mg/kg/day in Swiss mice (Toth 1972) and 8.8 (M) - 12 (F) mg/kg/day lifetime in Syrian golden hamsters (Toth and Shimizu 1973)
- NOAEC inhalation, 1 year exposure only (Kinkead 1985) = 5 ppm in M/F F344 rats, 0.02 ppm (LOAEC: 0.2 ppm) in F C57BL/6 mice and 0.2 ppm (LOAEC: 2 ppm) in M Syrian Golden hamsters. 1 ppm = 1.9 mg/m3 at 20 -25°C, atmospheric pressure.
Carcinogenicity: via inhalation route (target organ): cardiovascular / hematological: other; digestive: cecum; digestive: liver; digestive: other; glandular: adrenal gland; respiratory: lung; respiratory: nose
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