Registration Dossier
Registration Dossier
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EC number: 202-873-5 | CAS number: 100-63-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
The limited data on toxicokinetics indicate that phenylhydrazine is well absorbed by inhalation, oral, and dermal routes and binds readily to haemoglobin in red blood cells. Metabolism seems to occur via ring hydroxylation and conjugation, probably with glucuronic acid. Excretion is primarily via the urine. Phenylhydrazine is toxic by single exposure via the oral route (LD50 80–188 mg/kg body weight) and is expected to be toxic by the inhalation and dermal routes (data from these routes of exposure are less clear). Phenylhydrazine has potential for skin and eye irritation, and there is evidence that it has skin-sensitizing properties in humans. Exposure to phenylhydrazine may cause damage to red blood cells, potentially resulting in anaemia and consequential secondary involvement of other tissues, such as the spleen and liver. Phenylhydrazine is mutagenic in vitro, and there is some evidence to indicate that it may express genotoxic activity in vivo. The substance is clearly carcinogenic in mice following oral dosing, inducing tumours of the vascular system. The mechanism for tumour formation is unclear, but a genotoxic component cannot be excluded. Hence, it is not considered possible to reliably identify a level of exposure at which there will be no risk of carcinogenic or genotoxic effects. There are no adequate data available regarding reproductive or developmental effects; hence, it is not possible to evaluate the risk to human health for these end-points. The level of risk in occupational settings is uncertain; as a result, there is a continuing requirement to reduce exposure levels as much as is reasonably practicable with the technology that is currently available. The lack of available data to serve as a basis for estimation of indirect exposure of individuals to phenylhydrazine from the general environment precludes the characterization of potential cancer risks for the general population.
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