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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:
- 17.62 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):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.05 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation required for oral to inhalation route as no inhalation study available.
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL, a default assessment factor is 1 considered applicable.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for subchronic to chronic studies considered applicable as test material administration for 108 days.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF for allometric scaling not required as the differences in allometry (respiration rate and rat to human body sizes) were considered in the conversion from oral to inhalation starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Relevant studies conducted to GLP and considered to be of reliability 1.
- AF for remaining uncertainties:
- 2
- Justification:
- An additional AF of 2 is applied as the repeat dose toxicity result has been read-across from a comparable supporting substance (structural analogue). Therefore an additional AF has been considered appropriate to address the additional uncertainty factor of using read-across data, such as minor potential differences between the absorption and toxicity of the substances.
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation required for oral to inhalation route as no inhalation study available.
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL, a default assessment factor is 1 considered applicable.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for subchronic to chronic studies considered applicable as test material administration for 108 days.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Relevant studies conducted to GLP and considered to be of reliability 1.
- AF for remaining uncertainties:
- 2
- Justification:
- An additional AF of 2 is applied as the repeat dose toxicity result has been read-across from a comparable supporting substance (structural analogue). Therefore an additional AF has been considered appropriate to address the additional uncertainty factor of using read-across data, such as minor potential differences between the absorption and toxicity of the substances.
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Inhalation:
Inhalation is not considered to be a significant route of exposure. However, a long-term DNEL for systemic effects have been derived, based on the results obtained from a one generation reproductive study in the rat with evaluation of subchronic toxicity (OECD 408 and 415) on a structurally similar, comparable substance.
Long-term systemic effects:
A modification of the dose descriptor starting point (oral to inhalation) was conducted. It is assumed as a worst case assumption that the oral absorption rate is 50% of that of the inhalation absorption. In practice this is unlikely to be the case based on the particle size distribution.
The corrected dose descriptor (NOAEC) for inhalation was calculated in accordance with the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.
The conversion of an oral rat NOAEL into a corrected inhalatory NOAEC to assess human inhalatory exposure was performed using the modification of starting point equation as given in Figure R. 8-3 (see below) for workers (in the case of 8 hour exposure/day).
Default parameters for rats and humans (for 8 hour exposure) were used for the modification of starting point under the allometric scaling principle as given in Table R. 8-2 of the above ECHA guidance.
Conversion of an oral rate N(L)OAEL into a correct inhalatory N(L)OAEC to assess human inhalatory exposure:
For workers (in case of 8h exposure/day):
Corrected inhalatory N(L)OAEC = oral N(L)OAEL x (1 / sRVrat) x (ABSoral-rat / ABSinh-human) x (sRVhuman / wRV)
Corrected inhalatory N(L) OAEC= 1000 mg/kg bw/day x (1 / 0.38 m3/kg/d) x (0.5) x (6.7 m3(8h) / 10 m3(8h))= 881.05 mg/m3
Where:
ABS: Absorption
sRV: standard Respiratory Volume
wRV: worker Respiratory Volume (light activity)
Default parametrs:
sRVrat (8 h) : 0.38m3/kg bw
sRVhuman (8 h) : 6.7 m3/ person
wRV (8 h): 10 m3/ person
The appropriate assessment factors were then applied to give an overall assessment factor of 50.
Long-term systemic DNEL (inhalation) = 17.62 mg/m3
This long-term inhalation systemic effect DNEL is used in the quantitative assessment of risk for systemic toxicity to workers via the inhalation route.
Local inhalation effects are not considered to be of concern due to inhalation not being a significant route of exposure.
Dermal:
A DNEL has been derived for long-term systemic effects by the dermal route, based on the results obtained from a one generation reproductive study in the rat with evaluation of subchronic toxicity (OECD 408 and 415) on a structurally similar, comparable substance.
Long-term systemic DNEL (dermal) = 5 mg/kg bw/day
This long-term dermal systemic effect DNEL is used in the quantitative assessment of risk for systemic toxicity to workers via the dermal route.
DNELs for local effects have not been derived but the substance is a skin sensitiser, so has been classed as a medium hazard for local effects. A qualitative assessment is considered sufficient for any possible local effects (sensitisation), taking into account use of PPE and industrial/professional use conditions.
General Population - Hazard via inhalation 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:
There is no anticipated exposure to the general public/consumers, as there are no consumer uses of the substance.
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
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:
- 2.5 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):
- 400
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not required as NOEAL from an oral study.
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL, a default assessment factor is 1 considered applicable.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for subchronic to chronic studies considered applicable as test material administration for 108 days.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general public
- AF for the quality of the whole database:
- 1
- Justification:
- Relevant studies conducted to GLP and considered to be of reliability 1.
- AF for remaining uncertainties:
- 2
- Justification:
- An additional AF of 2 is applied as the repeat dose toxicity result has been read-across from a comparable supporting substance (structural analogue). Therefore an additional AF has been considered appropriate to address the additional uncertainty factor of using read-across data, such as minor potential differences between the absorbsion and toxicity of the substances.
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
DNELs have not been derived for the general public (apart from via the oral route for systemic effects) as there is no anticipated exposure to the general public/consumers, as there are no consumer uses of the substance. The only uses are industrial and heavy professional use.
A DNEL for long term systemic effects via the oral route has been derived, in order to assess indirect exposure of humans via the environment.
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