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Diss Factsheets
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EC number: 207-050-4 | CAS number: 428-59-1
- 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:
- 7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 170.85 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEC was 340 mg/m3 in an OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test). In the same study, systemic toxicity (histopathological effects in brain) in male and female rats was observed at exposure concentrations ≥ 250 ppm (1698 mg/m3). In other 90-day inhalation studies involving rats, rabbits, and dogs, no histopathological effects in brain were observed at the highest dose tested (400 ppm (2716 mg/m3)). Therefore, it is likely that 340 mg/m3 is a very conservative value. 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 (6.7m3/10m3) 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 most conservative NOAEL from a variety of repeated exposure studies conducted in multiple species of laboratory animals. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for differences in duration of exposure:
- 2
- Justification:
- Multiple repeated inhalation studies (90-day) were conducted in multiple species (rat, rabbit and dog). Additionally, an OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test). There were no toxicity endpoints that increased in severity or appearance with extended exposure. Based on the extensive 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:
- 2.5
- Justification:
- Since there are no data to justify a reduction or increase in the interspecies default assessment factor, a default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 5
- Justification:
- Since there are no data to justify a reduction or increase in the intraspecies default assessment factor, a default 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
This substance is volatile, and is being registered as a monomer in an imported polymer. Therefore, no exposure to workers is expected, and no risk assessment is required. Our interpretation of the REACh regulation is that a DNEL is required, even if no risk assessment is required. The substance is a gas, and therefore, only a DNEL long-term exposure via the inhalation route was calculated.
This substance is classified as Acute Toxicity Category 3, STOT SE Category 3 (Respiratory irritation) and STOT RE Category 2 (Brain histopathology) according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. The substance is classified as Xn:R20 Harmful by inhalation according to EU Directive 67/548/EEC.
The male and female rat 4-hour inhalation LC50= 2072 ppm (14069 mg/m3). At concentrations ≥ 2500 ppm (16975 mg/m3), the substance was judged as irritating to respiratory tissues. Multiple subchronic (90-day inhalation) studies were conducted in several species. In subchronic dog and rabbit studies, the NOEC was 100 ppm (679 mg/m3), based on respiratory irritation at exposure concentrations of 400 ppm (2716 mg/m3). In a rat 90-day subchronic study, the NOEC in male rats was 400 ppm. In female rats, decreased urine excretion volumes were observed in 100 and 400 ppm exposure groups. In an OECD 422 study, systemic toxicity (histopathological effects in brain) in male and female rats was observed at exposure concentrations ≥ 250 ppm (1698 mg/m3). The systemic effect NOAEC for the OECD 422 was 50 ppm (340 mg/m3). No adverse reproductive effects were observed at 500 ppm (3395 mg/m3), which was the highest concentration tested. No adverse developmental effects were observed at concentrations lower than or equal to the NOAEC for systemic toxicity in maternal animals.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 85 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEC was 340 mg/m3 in an OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test). In the same study, systemic toxicity (histopathological effects in brain) in male and female rats was observed at exposure concentrations ≥ 250 ppm (1698 mg/m3). In other 90-day inhalation studies involving rats, rabbits, and dogs, no histopathological effects in brain were observed at the highest dose tested (400 ppm (2716 mg/m3)). Therefore, it is likely that 340 mg/m3 is a very conservative value. 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 most conservative NOAEL from a variety of repeated exposure studies conducted in multiple species of laboratory animals. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for differences in duration of exposure:
- 2
- Justification:
- Multiple repeated inhalation studies (90-day) were conducted in multiple species (rat, rabbit and dog). Additionally, an OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test). There were no toxicity endpoints that increased in severity or appearance with extended exposure. Based on the extensive 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:
- 2.5
- Justification:
- Since there are no data to justify a reduction or increase in the interspecies default assessment factor, a default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 10
- Justification:
- Since there are no data to justify a reduction or increase in the intraspecies default assessment factor, a default 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 is appropriate for route-to-route extrapolation 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
This substance is volatile, and is being registered as a monomer in an imported polymer. Therefore, no exposure to workers is expected, and no risk assessment is required. Our interpretation of the REACh regulation is that a DNEL is required, even if no risk assessment is required. The substance is a gas, and therefore, only a DNEL long-term exposure via the inhalation route was calculated.
This substance is classified as Acute Toxicity Category 3, STOT SE Category 3 (Respiratory irritation) and STOT RE Category 2 (Brain histopathology) according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. The substance is classified as Xn:R20 Harmful by inhalation according to EU Directive 67/548/EEC.
The male and female rat 4-hour inhalation LC50= 2072 ppm (14069 mg/m3). At concentrations ≥ 2500 ppm (16975 mg/m3), the substance was judged as irritating to respiratory tissues. Multiple subchronic (90-day inhalation) studies were conducted in several species. In subchronic dog and rabbit studies, the NOEC was 100 ppm (679 mg/m3), based on respiratory irritation at exposure concentrations of 400 ppm (2716 mg/m3). In a rat 90-day subchronic study, the NOEC in male rats was 400 ppm. In female rats, decreased urine excretion volumes were observed in 100 and 400 ppm exposure groups. In an OECD 422 study, systemic toxicity (histopathological effects in brain) in male and female rats was observed at exposure concentrations ≥ 250 ppm (1698 mg/m3). The systemic effect NOAEC for the OECD 422 was 50 ppm (340 mg/m3). No adverse reproductive effects were observed at 500 ppm (3395 mg/m3), which was the highest concentration tested. No adverse developmental effects were observed at concentrations lower than or equal to the NOAEC for systemic toxicity in maternal animals.
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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