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EC number: 237-163-4 | CAS number: 13676-54-5
- 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
Key value for chemical safety assessment
Additional information
No specific study was performed on the absorption/distribution/metabolism/excretion (ADME) of this substance (BMI) but data are currently available from the in vivo toxicology studies.
Absorption
Oral route
During acute oral studies in rats all behavioural, clinical and physiological responses after administration were considered normal. The oral LD50for BMI was >2000 mg/kg body weight in female rats. Without pharmacokinetic data it is difficult to say if absorption occurred in these studies.
In a repeat dose (28-day) study no toxicologically significant adverse systemic effects were noted and there was no effect of treatment on reproductive performance, including mating performance, fertility and offspring survival and development up to Day 7 of age. The presence of vacuolated macrophages in the mesenteric lymph nodes may be an indication of accumulation of the test material, following adsorption through the gastro-intestinal tract.
Dermal route
An acute dermal study was not performed as this was not considered to be an appropriate route of exposure.
A M+K guinea pig sensitiser study showed BMI to be a moderate sensitiser, however, as no effects were noted in the control animals this is not indicative of adsorption.
Inhalation route
An acute inhalation toxicity study was performed where rats were subjected to a single 4-hour snout-only exposure with the test substance at target concentrations of 2.0, 1.0 or 0.5 mg/L, and a target Mass median aerodynamic diameter (MMAD) of 4 µm, in a stepwise fashion. Following exposure the rats were monitored for 15 days or until death or sacrifice if determined as necessary on justification of animal welfare concerns. After 15 days the surviving animals were sacrificed and subject to a macroscopic examination, all animals that died during the course of the study were also subject to a macroscopic examination. During the course of the study several rats died prematurely and many clinical signs, mainly associated with the lungs, were noted, however, it is considered that all mortalities were a result of localised toxicity to the respiratory tract. There is no evidence, therefore, that adsorption of the test material occurred during this study.
Distribution
The findings from the combined repeat dose and reproductive screening study did not provide evidence that BMI was distributed systemically following oral administration.It was concluded that oral administration of BMI to Crl: CD (SD) rats for at least 5 weeks at doses of 100, 300 and 1000 mg/kg bw/day was well tolerated with no toxicologically significant adverse systemic effects and there was no effect of treatment on reproductive performance, including mating performance, fertility and offspring survival and development up to Day 7 of age. It was considered that the presence of vacuolated macrophages in the mesenteric lymph nodes might be an indication of accumulation of test material, following adsorption through the GI tract but this has not been proven.
Metabolism
No data are available on metabolism in the existing toxicity studies. The clinical signs seen in the acute inhalation study wereconsidered to be a result of localised toxicity to the respiratory tract.
Excretion
No data are available on excretion in the existing toxicity studies.
Conclusion
From the data available so far there is no evidence that the test substance is absorbed via the gastrointestinal tract following oral (or inhalation) administration or via the skin following dermal administration.
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