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EC number: 435-860-1 | CAS number: 214417-91-1
- 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
Link to relevant study record(s)
Description of key information
Toxicokinetic Assessment by a certified toxicologist.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
The acute oral and dermal toxicity of the test substance is
low, with the LD50 being higher than 2000 mg/kg body in
both cases. The 28-day toxicity study also revealed that
the substance has a low toxicity, with a NOAEL of 50
mg/kg/day. Therefore, an extensive toxicokinetic assessment
is considered of limited value. Below,
an assessment of the anticipated toxicokinetic behaviour of BMH is given.
The water solubility of BMH is relatively low (4.37 mg/l), and therefore considered a rate-limiting factor for the absorption of the compound from the gastro-intestinal tract. Generally, the bioavailability of BMH from the gastro-intestinal tract is anticipated to be low. However, in the presence of food or bile salts, the bioavailability of BMH may well be enhanced. The compound will be positively charged on the amide group throughout the gastro-intestinal tract. Since the compound needs to pass the lipid membranes, the ionization of the compound will impair its uptake.
For risk assessment purposes oral absorption of BMH is set at 50%.
After absorption of BMH, several metabolic steps may take place. The bond between the two nitrogens may be split, forming the corresponding cyano compound and the free amide group, which can than be conjugated, most probably by acetylation or glucuronidation. Hydroxylation of the unsaturated ring in the molecule by the P450 enzyme system is anticipated. The hydroxy-metabolites will be conjugated and excreted via urine or bile. This P450-mediated enzymatic hydroxylation is a known pathway leading to induction of liver enzymes and liver hypertrophy as was also observed in the 28-day toxicity study. However, this finding should be considered an adaptive response to the presence of a xenobiotic, rather than a toxic response. The changes in plasma concentrations of ALAT and ASAT are a well-known phenomenon related to the liver hypertrophy.
Because of the low water solubility, the unchanged compound will hardly be excreted via the kidneys.
Distribution
of BMH will be limited to total body water, because of the relatively
low log Po/w. Therefore, a volume of distribution of about
0.7l/kg is expected.Uptake
via inhalation may well take place, because of the particle size
distribution
(25% < 4.5 µm). For risk assessment purposes inhalation absorption is
set at 100%.
Since the bioavailability of dermally applied compounds can be assumed to be zero for substances with a log Po/wbelow -1 and over 5 or a relative molecular mass over 700, it is to be expected that BMH will be absorbed to some extent through the skin. For risk assessment purposes dermal absorption is set at 50%.
Based on the expected kinetic behaviour in the body, as described above, BMH will not be extensively absorbed form the gastro-intestinal tract and when absorbed, it will be extensively metabolised. Therefore, accumulation in the body during prolonged exposure is not anticipated.
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.
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