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EC number: 411-280-2 | CAS number: 74091-64-8 MR-8A; MR-N2; NBDI
- 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)
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: toxicokinetic assessment
- Adequacy of study:
- key study
- Study period:
- April - December 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Toxicokinetic assessment by a certified toxicologist
- Qualifier:
- according to guideline
- Guideline:
- other: ECB EU Technical Guidance Document on Risk Assessment, 2003
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance
- GLP compliance:
- no
- Type:
- absorption
- Results:
- For risk assessment purposes: oral absorption 100%, inhalation absorption 100% and dermal absorption 100%
- Conclusions:
- For risk assessment purposes: oral absorption 100%, inhalation absorption 100% and dermal absorption 100%.
Reference
TOXICOKINETIC ASSESSMENT
In general, a compound needs to be dissolved before it can be taken up from the gastro-intestinal tract after oral administration). The substance (NBDI) is insoluble in water, and reacts slowly with water. Therefore, passive diffusion will be limited. In addition, ionization of NBDI will impair the uptake since compounds need to pass the lipid membranes in the gastrointestinal wall. The relatively low molecular weight (206.24) of the substance however indicates that uptake can take place through aqueous pores. It is likely that uptake will be enhanced by local damage caused by the irritating properties of the substance. Overall, it is likely that NBDI is absorbed from the gastro-intestinal tract. For risk assessment purposes oral absorption of NBDI is set at 100%, due to the irritating properties of the substance, leading to potentially damaged gastrointestinal wall. The results of the toxicity studies do not provide reasons to deviate from this proposed oral absorption factor.
Once absorbed, distribution of the substance throughout the body is expected based on its relatively low molecular weight. Absorbed NBDI might undergo conjugation. The conjugates will either be excreted via the bile (high molecular weight compounds) or the urine (low molecular weight compounds).
The low vapour pressure (0.02076 Pa) and high boiling point indicates that is not likely that NBDI will reach the nasopharyncheal region or subsequently the tracheo/bronchial/pulmonary region. However, if the substance reaches the tracheobronchial region, it is likely to be absorbed through the aqueous pores due to the low molecular weight (206.24). In addition, the reactivity of NBDI with water is favourable for absorption. For risk assessment purposes the inhalation absorption of NBDI is set at 100%. The results of the toxicity studies do not provide reasons to deviate from this proposed dermal absorption factor.
NBDI, being a liquid, has the potential to partition from the stratum corneum into the epidermis. Since the substance reacts with water and has irritating properties, significant dermal uptake is likely due to damaged skin. As the data are insufficient to meet the criteria for 10% dermal absorption as given in Endpoint specific Guidance (MW> 500 and log Pow <-1 or >4), 100% dermal absorption of NBDI is proposed for risk assessment purposes.
Description of key information
For risk assessment purposes the dermal, oral and inhalation absorption is set at 100%
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
TOXICOKINETIC ASSESSMENT
In general, a compound needs to be dissolved before it can be taken up from the gastro-intestinal tract after oral administration). The substance (NBDI) is insoluble in water, and reacts slowly with water. Therefore, passive diffusion will be limited. In addition, ionization of NBDI will impair the uptake since compounds need to pass the lipid membranes in the gastrointestinal wall. The relatively low molecular weight (206.24) of the substance however indicates that uptake can take place through aqueous pores. It is likely that uptake will be enhanced by local damage caused by the irritating properties of the substance. Overall, it is likely that NBDI is absorbed from the gastro-intestinal tract. For risk assessment purposes oral absorption of NBDI is set at 100%, due to the irritating properties of the substance, leading to potentially damaged gastrointestinal wall. The results of the toxicity studies do not provide reasons to deviate from this proposed oral absorption factor.
Once absorbed, distribution of the substance throughout the body is expected based on its relatively low molecular weight. Absorbed NBDI might undergo conjugation. The conjugates will either be excreted via the bile (high molecular weight compounds) or the urine (low molecular weight compounds).
The low vapour pressure (0.02076 Pa) and high boiling point indicates that is not likely that NBDI will reach the nasopharyncheal region or subsequently the tracheo/bronchial/pulmonary region. However, if the substance reaches the tracheobronchial region, it is likely to be absorbed through the aqueous pores due to the low molecular weight (206.24). In addition, the reactivity of NBDI with water is favourable for absorption. For risk assessment purposes the inhalation absorption of NBDI is set at 100%. The results of the toxicity studies do not provide reasons to deviate from this proposed inhalation absorption factor.
NBDI, being a liquid, has the potential to partition from the stratum corneum into the epidermis. Since the substance reacts with water and has irritating properties, significant dermal uptake is likely due to damaged skin. As the data are insufficient to meet the criteria for 10% dermal absorption as given in Endpoint specific Guidance (MW> 500 and log Pow <-1 or >4), 100% dermal absorption of NBDI is proposed for risk assessment purposes.
Discussion on absorption rate:
The substance being a liquid has the potential to partition from the stratum corneum into the epidermis. Since the substance reacts with water and has irritating properties, dermal uptake is likely. As the data are insufficient to meet the criteria for 10% dermal absorption as given in the Endpoint specific Guidance (MW> 500 and log Pow <-1 or >4), 100% dermal absorption is proposed for risk assessment purposes.
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