Registration Dossier
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EC number: 274-581-6 | CAS number: 70356-09-1
- 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

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:
- DNEL (Derived No Effect Level)
- Value:
- 22.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 555 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is starting point (default factor)
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from sub-chronic study to chronic exposure (default factor)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences in interspecies variability
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required, data base considered of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.49 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 450 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 649 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
According to ECHA Guidance R.8, the route to route extrapolation based on the assumption that the dermal uptake is equal to oral uptake.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is starting point (default factor)
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from sub-chronic study to chronic exposure (default factor)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- interspecies conversion metabolism, allometric scaling factor rat - human (default factor)
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required, data base considered of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Acute DNELs:
- Local effects: Derivation of DNELs not applicable, as no significant skin or eye irritating effects were observed in the acute in vivo studies. Furthermore no data on respiratory irritation are available.
- Systemic effects: Dermal DNEL derivation not applicable, as no significant systemic toxic effects were observed in the acute in vivo skin toxicity study. Inhalation DNEL derived from long-term inhalation DNEL.
Long-term DNELs:
- Local effects: Derivation of DNELs not applicable, as no significant skin or eye irritating effects were observed in the acute in vivo studies. Long term dermal toxicity studies without significant irritating effects. Furthermore no data on respiratory irritation are available.
- Systemic effects: Dermal DNEL derived from NOAEL observed on the oral 90-days repeated dose toxicity study (route to route extrapolation, assuming dermal uptake to be equal to oral uptake). Inhalation DNEL derived from NOAEL observed in the oral 90 -days repeated dose toxicity study. This value was converted into a NOAEC for human inhalation exposure according to ECHA Guidance R.8 taking into account allometric scaling, exposure duration, human breathing volume for workers and body weight. Route to route extrapolation from oral to inhalation includes furthermore a factor of 2 (worst case assumption).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 450 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
According to ECHA Guidance R.8, the route to route extrapolation based on the assumption that the dermal uptake is equal to oral uptake.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is starting point (default factor)
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from sub-chronic study to chronic exposure (default factor)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- interspecies conversion metabolism, allometric scaling factor rat - human (default factor)
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required, data base of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 450 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
not applicable
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is starting point (default factor)
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from sub-chronic study to chronic exposure (default factor)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- interspecies conversion metabolism, allometric scaling factor rat - human (default factor)
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required, data base of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Acute DNELs:
- Local effects: Derivation of DNELs not applicable, as no significant skin or eye irritating effects were observed in the acute in vivo studies. Furthermore no data on respiratory irritation are available.
- Systemic effects: Dermal DNEL derivation not applicable, as no significant systemic toxic effects were observed in the acute in vivo skin toxicity study. Inhalation DNELs not applicable to the general population, as BMBDM only is being used in consumer products as sun screens or other cosmetic products, without significant exposure to aerosols. Handling of BMDBM powder limited to industrial formulation sites, thus no consumer exposure to BMDBM dust particles possible. Acute oral DNEL not derived as no hazard identified.
Long-term DNELs:
- Local effects: Derivation of DNELs not applicable, as no significant skin or eye irritating effects were observed in the acute in vivo studies. Long term dermal toxicity studies without significant irritating effects. Furthermore no data on respiratory irritation are available.
- Systemic effects: Dermal and oral DNEL derived fom NOAEL observed on the oral 90-days repeated dose toxicity study (route to route extrapolation, assuming dermal uptake to be equal to oral uptake). Inhalation DNELs not applicable to the general population, as BMBDM only is being used in consumer products as sun screens or other cosmetic products, without significant exposure to aerosols. Handling of BMDBM powder limited to industrial formulation sites, thus no consumer exposure to BMDBM dust particles possible.
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