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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 236-690-7 | CAS number: 13464-97-6
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 0.13 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
Due to data point waiving, no data are available for hydrazine mono-nitrate. Please see each individual endpoint for details of the waiver.
All toxicological data required for hydrazine mono-nitrate under REACH Annexes VII and VIII has been waived (apart from anin vitrobacterial mutagenicity test) due to existing classification or exposure control. Therefore, it is not possible to derive DN(M)EL(s) for mammalian endpoints as test data are absent.
REACH (Annex 1) states that if a DN(M)EL cannot be derived “this shall be clearly stated and justified”.
Hydrazine mono-nitrate is a category 1b carcinogen. For carcinogens and mutagens, the Carcinogens and Mutagens Directive (2004/37/EC) requires that workplace exposures are avoided/minimised as far as technically feasible. As REACH does not overrule the Carcinogens and Mutagens Directive, the approach to controlling workplace exposure should therefore comply with this minimisation requirement.
As hydrazine mono-nitrate is a carcinogen and a positive result has been obtained in a bacterial mutagenicity testin vitro, a DMEL should be derived, if possible.
For workplace exposure, there may already exist occupational exposure limits (OELs) and/or the underlying information used for setting the OELs can be used to derive DNELs.
An indicative Occupational Exposure Limit for hydrazine mono-nitrate or hydrazine does not exist.
A registrant cannot use a national OEL in place of a DNEL without an evaluation of the scientific background for the setting of the national OEL. In cases where the evaluations of health effects used for setting the national OEL are documented this may be taken into account in deriving the DNEL.
Aworkplace Exposure Limit (WEL) exists for hydrazine of0.03 mg/m³ (8-hr TWA) and 0.13 mg/m³ (STEL, 15-minute reference period) with ‘Sk’ notation and ‘Carc’ notation added.
It is proposed that thesefor hydrazine are used as DMELs and read-across to hydrazine mono-nitrate for short-term inhalation exposure and that the Carcinogens Directive is invoked.
Basis for setting the Limit
Human data on the toxicity of hydrazine are limited, and in particular it is not possible to correlate the effects observed with specified doses/exposure levels. Hence suitable occupational exposure limits must be based largely on the results of animal studies.
Hydrazine is clearly carcinogenic in animals, producing tumours in the nasal cavity on inhalation and in the liver following repeated oral administration. These findings are considered relevant to human health; the significance of the other tumours seen in animal experiments is less certain. Chronic tissue damage is likely to have been a very influential factor in the aetiology of these tumours. However, in view of the genotoxicity of hydrazine in vitro and the possibility that this activity id expressed in vivo, it cannot be discounted that such effects could contribute to the carcinogenic process.
Furthermore, a clear NOAEL for repeated inhalation exposure in animals has not been identified. Hydrazine is also a developmental toxicant in animals, dose-response relationships for these effects being poorly characterised.
In view of these factors it was concluded that an OES cannot be set for hydrazine and a WEL is considered appropriate. The main uses of hydrazine in theare in boiler water treatment, particularly in the electricity generating industry, and in chemical manufacture. In boiler water treatment there is potential for exposure when hydrazine is transferred from drums to the dosing tanks. This operation is of short duration and all firms specify the use of protective clothing and some use of RPE. Limited exposure data suggests that the short-term exposures are less than 0.1 ppm. Recent contacts with the chemical manufacturing industry indicate that exposure to airborne hydrazine is controlled by process enclosure and provision of LEV at the bund hole of the drum during reactor charging. The limited background monitoring data supplied by industry that personal; exposure are likely to be below 0.1 ppm during these operations.
In view of the hygiene data supplied by industry the short duration of exposure and the string irritative effects of hydrazine a short term MEL was set of 0.1 ppm for a 15 minute reference period. However, the rat carcinogenicity study showed tumours occurring following inhalation exposure at 0.05 ppm for 30 hours per week for a year. WATCH considered that the tumours at this concentration could not be discounted. In view of the control that can be achieved it was proposed that total exposure should be limited by a MEL of 0.02 ppm 8-hour TWA.
Toxicokinetics show that significant skin absorption can occur, and thus a skin notation was set.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Due to data point waiving, no data are available for hydrazine mono-nitrate.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.