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Diss Factsheets
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EC number: 431-870-3 | 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:
- 0.364 mg/m³
- Most sensitive endpoint:
- genetic toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- other: BMD10
- Value:
- 62 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 54.65 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for inhalation exposure for workers is was derived using lowest available NOAEL derived from the Comet assay based on the values derived for the effects seen in the liver. The EPA Benchmark dose software was used to derive the BMD10 value based on the liver values in the comet assay which resulted in a point of departure of 62mg/kg/day. This value further used in the deriving the modified starting point for the inhalation DNEL.
NOAEC (The DNEL for inhalation exposure for workers is given by the formula: corrected inhalation NOAEC= LOAEL(oral-rat) * 1/sRVrat * (Absorption (oral-rat) / Absorption(inhal-human)) * (sRVhuman/wRV) Where SRV is the standard Respiratory Volume and wRV is the worker Respiratory Volume. The default values assumed for these factors are as follows: Absorption(oral-rat) =50%; Absorption(inhal-human) =100%; sRVrat=0.38 m3/kg/d; sRVhuman= 6.7m3 (8hr); wRV=10m3(8hr). NOAEC(corrected) = 62 mg/kg bw/day* (1/0.38 m3/kg/d) *(50%/100%) * 6.7m3 (8hr) / 10m3(8hr) NOAEC(corrected) = 54.65 mg/m3)
- AF for dose response relationship:
- 3
- Justification:
- ECHA, 2010 Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health states when the starting point for the DNEL calculation is a LOAEL, it is suggested to use an assessment factor between 3 (as minimum/majority of cases) and 10 (as maximum/exceptional cases).
However, the benchmark dose (BMD) approach is, when possible, preferred over the LOAEL/NAEL extrapolation. A BMD calculated as the lower confidence limit of the dose that produces a response of 5% (BMD5) has, on average, been proposed to be comparable to a NOAEL (WHO, 2000). If other BMD indicators are used, e.g. a BMD10, it should be considered on a case-by-case basis whether an additional dose-response assessment factor is needed. The Benchmark-dose representing a 10% response was used in this instance. When the starting point for the DNEL calculation is a NOAEL, the default assessment factor, as a standard procedure, is 1 but that a larger assessment factor may be applied. In this instance the value of 3 has been selected to take into account any concerns related to the use of the BMD10 value - AF for differences in duration of exposure:
- 10
- Justification:
- ECHA guidance document Chapter R8, in Table R.8-5, indicates that a higher factor may for instance be used if there are indications for potential severe chronic effects, which cannot possibly be detected in a short term study. In this case a conservative value of 10 has been selected
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already included in the route to route extrapolation from the Comet assay BMD10 value to the equivalent human inhalation NOAEC.
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive review (see discussion) that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 has been applied.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA, 2010 Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2 December 2010. Value of 5 used to represtnt workers as per the guidance
- AF for the quality of the whole database:
- 1
- Justification:
- The BMD10 was derived from a Guideline study conducted to GLP and is judged to be of high quality and reliable results
- AF for remaining uncertainties:
- 1
- Justification:
- All uncertainties are already included so a factor of 1 is applied
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.103 mg/kg bw/day
- Most sensitive endpoint:
- genetic toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- other: BMD10
- Value:
- 62 mg/kg bw/day
- Modified dose descriptor starting point:
- BMD05
- Value:
- 62 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
ECHA guidance assumes that absorption for dermal exposure is the same as for oral exposure, which is a worst case assumption.
- AF for dose response relationship:
- 3
- Justification:
- ECHA, 2010 Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human healt states when the starting point for the DNEL calculation is a LOAEL, it is suggested to use an assessment factor between 3 (as minimum/majority of cases) and 10 (as maximum/exceptional cases).
However, the benchmark dose (BMD) approach is, when possible, preferred over the LOAEL/NAEL extrapolation. A BMD calculated as the lower confidence limitof the dose that produces a response of 5% (BMD5) has, on average, been proposed to be comparable to a NOAEL (WHO, 2000). If other BMD indicators are used, e.g. a BMD10, it should be considered on a case-by-case basis whether an additional dose-response assessment factor is needed. The Benchmark-dose representing a 10% response was used in this instance. When the starting point for the DNEL calculation is a NOAEL, the default assessment factor, as a standardprocedure, is 1 but that a larger assessment factor may be applied. In this instance the value of 3 has been selected to take into account any concerns related to the use of the BMD 10 value - AF for differences in duration of exposure:
- 10
- Justification:
- ECHA guidance document Chapter R8, in Table R.8-5, indicates that a higher factor may for instance be used if there are indications for potential severe chronic effects, which cannot possibly be detected in a short term study. In this case a conservative value of 10 has been selected
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- In the absence of dermal absorption data, equivalence is assumed. A default allometric scaling factor of 4 between rats and humans is applied.
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive review (see discussion) that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 has been applied
- AF for intraspecies differences:
- 5
- Justification:
- ECHA, 2010 Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2 December 2010. Value of 5 used to represtnt workers as per the guidance
- AF for the quality of the whole database:
- 1
- Justification:
- The BMD10 was derived from a Guideline study conducted to GLP and is judged to be of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- uncertainties are already included so a factor of 1 is applied
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Selection of Assessment factors for Intra – Inter species variation for workersvariation for workers
ECHA (2010) has produced guidance on the assessment factors to use to derive a DNEL for human exposure based the application of assessment factors (safety factors) to an NOAEL or LOAEL in animal studies. The ECHA guidance proposes an assessment factor of 4 for the allometric scaling from rats to humans when calculating oral and dermal DNELs. However it then proposes an additional factor of 2.5 to cover remaining differences (uncertainties). There is no clear scientific justification for this additional factor. ECETOC in itsGuidance on Assessment Factors to Derive a DNEL(2010) reviewed the scientific evidence and concluded that the factor of 4 for rats was sufficient to cover the allometric scaling from rats to humans and any remaining differences are of intra-species rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter-species variability will not be used.
References:
ECHA, 2010 Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2 December 2010
ECETOC, 2010Guidance on Assessment Factors to Derive a DNEL,Technical Report No.110,ISSN-0773-8072-110 (print),ISSN-2079-1562-110 (online), October 2010
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:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
BMS 217947 is an intermediate, manufactured under strict engineering control conditions; there is no potential for exposure of the General Population.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
BMS 217947 is an intermediate, manufactured under strict engineering control conditions; there is no potential for exposure of the General Population.
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:
- no hazard identified
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
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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