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Registration Dossier
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EC number: - | CAS number: -
- 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:
- 0.12 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):
- 750
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 88.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
LOAELoral 100 mg/kg/d x (1/0.38 m3.kg-1.d-1) x (50% rat oral / 100% human inhal) x (6.7 m3 / 10 m3) = LOAECinhal 88.1 mg/m3
- AF for dose response relationship:
- 10
- Justification:
- Extrapolation from LOAEL to NAEL (NOAEL). See below for a justification of the AF used
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor extrapolation from subchronic to chronic duration
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required for oral to inhalation conversion of starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for worker exposures
- AF for the quality of the whole database:
- 1
- Justification:
- Data appropriate for manufacturing intermediate
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.033 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):
- 3 000
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
LOAELoral 100 mg/kg/d x (50% rat oral / 50% derm abs human) = LOAELdermal 100 mg/kg/d
- AF for dose response relationship:
- 10
- Justification:
- Extrapolation from LOAEL to NAEL (NOAEL). See below for a justification of the AF used
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor extrapolation from subchronic to chronic duration
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor from rats to man
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for worker exposures
- AF for the quality of the whole database:
- 1
- Justification:
- Data appropriate for manufacturing intermediate
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The material has been adequately tested for a production intermediate. Acute toxicity data does not indicate requirement for classification via the dermal or oral route. No acute inhalation toxicity data has been generated. The material was irritating to eyes and was a skin sensitiser. In an OECD 422 combined repeat dose toxicity and reproductive screening study, the LOAEL (100 mg/kg bw/d) was established on multiple effects, the most severe of these being accumulation of macrophages in the lungs of females and hepatotoxicity in males, effects on male reproductive organs male pituitary glands, adrenal glands and thyroids were noted, although there were no effects on reproduction. In accordance with ECHA guidance document R8 (2012), an attempt was made to estimate the NOAEL using the BMD and associated methodologies outlined in R.8 (2012). These indicated that the NOAEL might be established at around 11 mg/kg bw/day for this study, or alternatively than an assessment factor with respect to the dose response relationship, might be established as 10. See the attached document. The material was not genotoxic in a battery of in vitro genotoxicity tests.
Long term DNELs were established on the basis of the LOAEL, in the usual way, with an additional AF of 10 for dose response (notionally extrapolating from a LOAEL to NOAEL) justified using techniques specified in the ECHA guidance. Local effects (inhalation and dermal) are considered likely hazards. For acute DNELs, these were not set, because controls preventing exceedance of the long term DNELs will also protect against acute/short term hazards. The material was considered hazardous for respiratory and skin local effects, but as controlled production intermediate no exposure should normally occur, and further data to establish precise DNELs for local effects is considered unnecessary.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
Given this is a production intermediate and is consumed in the production of other materials, no exposure of the public is anticipated and general population DNELs are not required.
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