Registration Dossier
Registration Dossier
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EC number: 202-873-5 | CAS number: 100-63-0
Carcinogenicity
Administrative data
Description of key information
Two studies assessing the carcinogenic potential of phenylhydrazine were available. Both studies revealed positive results with tumours formed in the vascular system following oral test item administration.
Key value for chemical safety assessment
Justification for classification or non-classification
Based on carcinogenic toxicity results obtained and according to Directive 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP), phenylhydrazine was classified as carcinogen ( cat 2, R45; cat 1B; H350).
Additional information
Non-human data:
Two studies assessing the carcinogenic potential of phenylhydrazine were available:
In the first, phenylhydrazine hydrochloride was administered daily by stomach tube for 42 weeks to 30 BALB/c mice, at an estimated dose level of 25 mg phenylhydrazine/kg body weight (Clayson et al., 1966). Thirty control animals were included in the study, but a control animal was killed whenever a treated animal died, to match survival rates. There was a statistically significant increase in the incidence of animals with lung tumours in the treated group (53 %) compared with controls (13 %). There was also a slight increase in the average number of tumours per mouse, and the majority of treated mice had multiple pulmonary tumours. Adenomas accounted for 83 % of pulmonary tumours in the treated group, half of which were judged to be becoming malignant, and 17 % of tumours were carcinomas.
In a second study phenylhydrazine hydrochloride was administered in drinking-water to 100 Swiss mice for their lifetime, at an estimated daily dose of 22 mg/kg body weight (Toth &, 1976). There were 200 control mice. Complete necropsy was performed on all animals. All organs were examined macroscopically, and histological analysis was performed on a wide range of tissues as well as on any organ showing gross pathology. Phenylhydrazine was reported to decrease survival in comparison with controls, and many of the treated decedents showed splenomegaly, although numbers were not given. There was a statistically significant increased incidence of blood vessel tumours (mainly angiosarcomas and angiomas) in the liver of treated animals (21 %) compared with controls (0 %).
Human data:
No data available
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