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Diss Factsheets
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EC number: 200-471-4 | CAS number: 60-34-4
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP. Some inconsistencies between summary and results. Unknown recovery due to several non-sampled matrices (air, carcass, feces).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1967
Materials and methods
- Objective of study:
- distribution
- excretion
- metabolism
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
- Remarks:
- prior to GLP
Test material
- Reference substance name:
- monomethylhydrazine
- IUPAC Name:
- monomethylhydrazine
- Details on test material:
- - Name of test material (as cited in study report): 14C-monomethylhydrazine
- specific activity of 3.1 µc/mM (60 µc/mL)
- no other details given
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C, position not stated
Test animals
- Species:
- other: see details below
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The material is water soluble, and aqueous dilutions were prepared fresh immediately prior to use
All animals were fasted overnight and weighed just prior to use.
HOMOGENEITY AND STABILITY OF TEST MATERIAL:
not applicable (fresh solutions)
no other details - Duration and frequency of treatment / exposure:
- single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
see details below
- No. of animals per sex per dose / concentration:
- see details below
- Control animals:
- no
- Positive control reference chemical:
- no
- Details on study design:
- - Dose selection rationale: doses were varied according to species based on preliminary dose response studies
- Rationale for animal assignment (if not random): no data - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
Groups of 4 or 5 animals each were injected with 14C-MMH and maintained in individual metabolism cages (or chairs, in the case of monkeys) for 2, 4, 8, or 24 hours.
Excreted urine was collected for each experimental period, and bladder urine was obtained at necropsy. Each animal was processed individually, except for the mice which were pooled in groups of 5 to obtain sufficient tissue material for analysis.
All animals were killed by pentobarbital sodium anesthesia and exsanguination. Blood samples were collected at this time. Necropsies were performed immediately, and whole organs were removed, weighed, and processed for liquid scintillation 1 4C counting.
Digestion of tissue samples, 100 to 150 mg, in 3 ml Hydroxide of Hyamine-lOX R was accomplished by overnight maintenance in a 56 C waterbath.
Blood serum samples were analyzed for MMH by colorimetry; urine volumes were recorded and samples were likewise analyzed by a slight modification of the same technique.
Efforts to analyze tissue samples for MMH content were unsuccessful. Therefore, distribution results for MMH in tissues are given solely in terms of 14C radioactivity.
Serially collected blood samples from some dogs and monkeys were also analyzed for methemoglobin by the method of Hainline.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- not applicable (injection)
- Details on distribution in tissues:
- The same four tissues had the highest concentrations of 14 C, in all four species: blood serum, liver, kidneys and bladder.
In every tissue analyzed, the dog and mouse showed the highest values at 4 h, the monkey showed its highest values at 2 hours and in the rat there was no apparent consistent pattern relative to time.
Appreciable amounts still present in the tissues at 24 hours after exposure, but with a clear decline over these 24h (except in mice where it was less clear).
- Details on excretion:
- Urine: high concentration in monkey urine at 2 hours and in dog urine at 4 hours.
Total percent excreted in urine at 24h: 26% in dog, 31% in monkey, 40% in rat, 9% in mice (inconsistent result in mice). The most rapid excretion was in mice.
No analysis of feces or exhaled air was attempted
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- approximately 50% of what is excreted is unchanged monomethylhydrazine. Also in blood the results of 14C dosing were higher than those of specific MMH levels.
Applicant's summary and conclusion
- Conclusions:
- Bioaccumulation potential cannot be judged based on study results unknown total recovery, expired air and feces not assayed
MMH evidenced a metabolism both in blood and excreted urine (about 50% was unchanged MMH).
Important excretion in urine occured in rats, monkeys, dogs and mice.
In all species the highest concentrations were in liver, kidney, bladder, pancreas, and blood serum.
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