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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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