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EC number: 206-114-9 | CAS number: 302-01-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Hydrazine (JETOC 1996) and hydrazine monohydrate (MHLW 1996) were tested
in the Ames test according to OECD TG 471 in the presence and in the
absence of an additional metabolic activation system and yielded
positive results.
Hydrazine was tested in the Mouse Lymphoma Assay in the absence of an
additional metabolic activation system and proved to be a mutagen but
mutagenicity was correlated with cytotoxicity (Rogers 1981)
According to OECD TG 473, hydrazine (JETOC 1996) and hydrazine
monohydrate (MHLW 2003) were tested for chromosomal aberrations using
Chinese Hamster Lung cells and yielded positive results. Hydrazine
hydrate in human lymphocytes (Bayer AG 1990) showed no relevant
chromosome aberrations.
In the mouse spot test according to OECD TG 484 the single
intraperitoneal injection of 40 and 80 mg/kg bw hydrazine hydrate into
pregnant female mice resulted in an non-significantly increased
frequency of Spots of Genetic Relevance (SGR) but it was of biological
relevance when compared to the historical control data of the performing
institute (Bayer AG 1989). A study using the transgenic mouse model
(Muta[TM] mouse) and the administration of a single oral dose of 400
mg/kg bw hydrazine sulphate, yielded negative results (Douglas 1995).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Additional information
Hydrazine, hydrazine monohydrate, and hydrazine hydrate yielded positive results when tested in the Ames test according to OECD TG 471 in the absence or in the presence of a metabolic activation system up to cytotoxicity. Tested in the Mouse Lymphoma Assay in the absence of metabolic activation hydrazine proved to be mutagenic but the mutagenicity was correlated with cytotoxicity. The in-vivo Mouse Spot Test yielded a non-significantly increased frequency of Spots of Genetic Relevance which was evaluated of biological relevance based on comparison with the historical control data of the performing institute only.
Hydrazine and hydrazine hydrate were tested for chromosome aberration in Chinese Hamster Lung cells. Both tests were performed according to the respective guideline in the presence and in the absence of metabolic activation and in concentration which ranges up to cytotoxicity. In both experiments chromosome aberrations were observed. Hydrazine hadrate was tested for chromosome aberration in human lymphocytes . The incubation time was 2 hours in the presence(+S9 -mix) and 24 hours in the absence (-S9 -mix) of a metabolic activation system. For evaluation the negative result of the chromosome aberration test in human lymphocytes it has to be taken into account that lymphocytes have to be stimulated with an exogen mitogen to undergo cell devision and that the cells in the presence of an additional metabolic activation system were incubated only for 2 hours instead of 3-6 hours as requested by the respective guideline.
In addition, there is an in-vivo MNT of limited validity performed with mice peripheral blood reticulocytes using different concentration levels of hydrazine hydrochloride and different dosing regimes: Mice received single intraperitoneal injections of 25, 50 or 100 mg/kg bw, or quadruple of 12.5, 25, 50 or 100 mg/kg bw, each 24 hours apart. The observed elevation of micronucleated reticulocytes showed neither dose-dependence nor relation to the expression time (Ohuchida et al 1995) and is therefore not regarded to provide reliable information. Hydrazine sulphate administered in a single oral dose of 400 mg/kg bw did not induce IacZ mutations in the lung, liver or bone marrow or transgenic mice sampled 14 and 56 days post treatment (Douglas 1995)
Overall, based on the available data, hydrazine showed evidence of a genotoxic activity, but the potential seems to be weak based on the fact that positive responses were not very pronounced and mainly in cytotoxic concentrations and that the in vivo studies do not give a clear positive response even at high doses.
Justification for selection of genetic toxicity endpoint
No individual endpoint study was selected. Overall, based on the
available data, hydrazine showed evidence of a genotoxic activity, but
the potential seems to be weak based on the fact that positive responses
were not very pronounced and mainly in cytotoxic concentrations and that
the in vivo studies do not give a clear positive response even at high
doses.
Endpoint Conclusion: weak positive.
Justification for classification or non-classification
- Under Regulation No. 1272/2008 (GHS) the substance is not classified in a mutagenic category.
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