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Diss Factsheets
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EC number: 200-872-4 | CAS number: 75-46-7
- 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:
- 1 439 mg/m³
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 14 389 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL was 28634 mg/m3 in a 90-day repeat inhalation study in rats. A modification (0.75) of starting point for worker exposure time as compared to animal exposure (6 hours vs. 8 hours) was applied per REACH guidance R.8.4.2. A modification (6.7 m3/10 m3) was applied to account for the increased respiratory volumes in active workers as compared to individuals at rest per REACH guidance R.8.4.2.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor is the NOAEL from a robust repeat-dose exposure study in rats that assessed a variety of endpoints. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for differences in duration of exposure:
- 2
- Justification:
- There was no systemic toxicity observed in rat and dog 90-day repeated inhalation studies conducted at 10000 ppm (28634 mg /m3) or 5000 ppm, respectively, nor in a rat developmental study conducted at 50000 ppm (143170 mg /m3). It is unlikely that increased exposure duration would produce systemic toxicity. Based on the robust repeated inhalation data, an assessment factor of 2 is appropriate per REACH guidance R.8.4.3.1.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- A factor of 1 is appropriate since the adjusted start point was via inhalation (mg/m3), per REACH guidance Appendix R. 8-2.
- AF for other interspecies differences:
- 1
- Justification:
- No systemic toxicity was observed in repeated inhalation exposures in multiple species, even at extremely high exposure concentrations. This substance is of very low toxicity, and is not likely to exert any “unique” effect on humans. Based on the lack of systemic toxicity in multiple species, an assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 5
- Justification:
- No systemic toxicity was observed in repeated inhalation exposures in multiple species, even at extremely high exposure concentrations. This substance is of very low toxicity, and is not likely to exert any “unique” effect on humans, and no sensitive workplace population would be expected. While the default assessment of 5 is considered overly conservative, in the absence of other arguments, a default assessment factor of 5 is appropriate per REACH guidance R.8.4.3.1.
- AF for the quality of the whole database:
- 1
- Justification:
- A high quality, robust toxicity database exists for this substance. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for remaining uncertainties:
- 1
- Justification:
- A factor of 1 for route-to-route extrapolation is appropriate since the animal exposure was via inhalation per REACH guidance R.8.4.2.
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:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - workers
The substance is a gas, and is not classified as hazardous or irritating. Any workplace exposure would occur via inhalation in unprotected workers, therefore, no dermal or oral DNELs are appropriate. The substance has very low acute inhalation toxicity, and no acute systemic or local effects DNELs are appropriate. The substance also has very low systemic toxicity potential. No systemic toxicity was observed in rats or dogs exposed for 90 days to the highest substance concentrations tested, 10000 ppm (28634 mg/m3) and 5000 ppm (14317 mg/m3), respectively. In addition, no systemic toxicity was observed during a rat pre-natal developmental toxicity study conducted at 50000 ppm (143170 mg/m3). The 90-day rat repeated inhalation study is the key study for use in risk assessment, and the NOAEC of 28634 mg/m3 (10000 ppm) is the starting point for DNEL calculation.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 358 mg/m³
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 7 159 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL was 28634 mg/m3 in a 90-day inhalation study in rats. A modification (0.25) of starting point for general population exposure time as compared to animal exposure (6 hours vs. 24 hours) was applied per REACH guidance R.8.4.2.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor is the NOAEL from a robust repeat-dose exposure study in rats that assessed a variety of endpoints. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for differences in duration of exposure:
- 2
- Justification:
- There was no systemic toxicity observed in rat and dog 90-day repeated inhalation studies conducted at 10000 ppm (28634 mg /m3) or 5000 ppm, respectively, nor in a rat developmental study conducted at 50000 ppm (143170 mg /m3). It is unlikely that increased exposure duration would produce systemic toxicity. Based on the robust repeated inhalation data, an assessment factor of 2 is appropriate per REACH guidance R.8.4.3.1.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- A factor of 1 is appropriate since the adjusted start point was via inhalation (mg/m3), per REACH guidance Appendix R. 8-2.
- AF for other interspecies differences:
- 1
- Justification:
- No systemic toxicity was observed in repeated inhalation exposures in multiple species, even at extremely high exposure concentrations. This substance is of very low toxicity, and is not likely to exert any “unique” effect on humans. Based on the lack of systemic toxicity in multiple species, an assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 10
- Justification:
- No systemic toxicity was observed in repeated inhalation exposures in multiple species, even at extremely high exposure concentrations. This substance is of very low toxicity, and is not likely to exert any “unique” effect on humans. While the default assessment of 10 is considered overly conservative, in the absence of other arguments, a default assessment factor of 10 is appropriate per REACH guidance R.8.4.3.1.
- AF for the quality of the whole database:
- 1
- Justification:
- A high quality, robust toxicity database exists for this substance. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for remaining uncertainties:
- 1
- Justification:
- A factor of 1 for route-to-route extrapolation is appropriate since the animal exposure was via inhalation per REACH guidance R.8.4.2.
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:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
The substance is a gas, and is not classified as hazardous or irritating. Any general population exposure would occur via inhalation; therefore, no dermal or oral DNELs are appropriate. The substance has very low acute inhalation toxicity, and no acute systemic or local effects DNELs are appropriate. The substance also has very low systemic toxicity potential. No systemic toxicity was observed in rats or dogs exposed for 90 days to the highest substance concentrations tested, 10000 ppm (28634 mg/m3) and 5000 ppm (14317 mg/m3), respectively. In addition, no systemic toxicity was observed during a rat pre-natal developmental toxicity study conducted at 50000 ppm (143170 mg/m3). The 90-day rat repeated inhalation study is the key study for use in risk assessment, and the NOAEC of 28634 mg/m3 (10000 ppm) is the starting point for DNEL calculation.
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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