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Diss Factsheets
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EC number: 213-551-9 | CAS number: 976-56-7
- 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:
- 3.9 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 84.1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 294.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no adequate experimental data on the repeated dose toxicity by the inhalation route available. Therefore, the worker-DNEL long-term for the inhalative route - systemic is derived from the oral NOAEL of 84.1 mg/kg bw/day, obtained in the key Repeated Dose Toxicity Study (similar to OECD TG 409) in Beagle dogs. The NOAECcorr. is calculated as follows:
- respiratory volume dog (8h exposure): 0.134m³/kg/8h
- respiratory volume workers in rest compared to workers in light activity (8h): 6.7 m³/10 m³
- absorption (oral, dog) = 50 % (default)
- absorption (inhalation, human) = 100 % (default)
- experimental exposure time = 7 days/week
- exposure time worker = 5 days/week
--> modified dose descriptor (corrected NOAEC) = 84.1 mg/kg bw/day * (1/0.134 m³/kg) * (6.7 m³/10 m³) * (50 %/100 %) * (7 d/5 d) = 294.4 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The recommended AF for the extrapolation from sub-chronic to chronic exposure is applied.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is part of the route to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 3
- Justification:
- An additional factor of 3 is applied for using a read-across approach
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:
- 1.1 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):
- 105
- Dose descriptor starting point:
- NOAEL
- Value:
- 84.1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 118 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no adequate experimental data on the dermal route available. The dermal route is typically covered by oral route information in the absence of data for this administration route. Since no data on penetration through skin are available, the NOAEL is not adjusted for dermal penetration properties. The DNEL is derived from the oral NOAEL of 84.1 mg/kg bw/day, obtained in the key Repeated Dose Toxicity Study (similar to OECD TG 409) in Beagle dogs. The NOAELcorr. is calculated as follows:
- absorption (oral, dog) = 50 % (default)
- absorption (dermal, human) = 50 % (default)
- experimental exposure time = 7 days/week
- exposure time worker = 5 days/week
--> modified dose descriptor (corrected dermal NOAEL) = 84.1 mg/kg bw/day * (50 %/50 %) * (7 d/5 d) = 118 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- Assessment factor of 2 is applied since the DNEL is derived from a subchronic study.
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default allometric scaling factor for the differences between dogs and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 3
- Justification:
- An additional factor is applied for using a read-across.
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
Identification of relevant dose descriptor
No repeated dose data is available with the test item. The 90-day toxicity study performed in Beagle dogs with a structural analogue was chosen as the most relevant study for safety assessment. In this study, groups of six male and female dogs were treated with the read-across substance continuously in feed. No treatment-related adverse effects have been observed up to the highest dose tested, thus a NOAEL of 84.1 (males) and 90.2 mg/kg body weight per day (females), was established. For derivation of DNELs, the lower value of 84.1 mg/kg was selected as calculation starting point.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.68 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 84.1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 102 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no adequate experimental data on the repeated dose toxicity by the inhalation route available. Therefore, the worker-DNEL long-term for the inhalative route - systemic is derived from the oral NOAEL of 84.1 mg/kg bw/day, obtained in the key Repeated Dose Toxicity Study (similar to OECD TG 409) in Beagle dogs. The NOAECcorr. is calculated as follows:
- respiratory volume dog (24h exposure): 0.403 m³/kg/8h
- absorption (oral, dog) = 50 % (default)
- absorption (inhalation, human) = 100 % (default)
--> modified dose descriptor (corrected NOAEC) = 84.1 mg/kg bw/day * (1/0.403 m³/kg) * (50 %/100 %) = 102 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is a NOAEL, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The recommended AF for the extrapolation from sub-chronic to chronic exposure is applied.
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- An allometric scaling factor for dogs is used to take tribute to the interspecies differences in the metabolic rate.
- AF for other interspecies differences:
- 2.5
- Justification:
- A default factor for remaining uncertainties is used.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the relatively heterogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 3
- Justification:
- An additional factor for using a read-across is applied
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.4 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):
- 210
- Dose descriptor starting point:
- NOAEL
- Value:
- 84.1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 84.1 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no adequate experimental data on the dermal route available. Therefore, the general population-DNEL long-term for dermal route - systemic is derived from the oral NOAEL of 84.1 mg/kg bw/day, obtained in the key Repeated Dose Toxicity Study (OECD TG 409) in Beagle dogs. The NOAELcorr. is calculated as follows:
- absorption (oral, dog) = 50 % (default)
- absorption (dermal, human) = 50 % (default)
- experimental exposure time = 7 days/week
- exposure time general population= 7 days/week
--> modified dose descriptor (corrected dermal NOAEL) = 84.1 mg/kg bw/day * (50 %/50 %) * (7 d/7 d) = 84.1 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- Assessment factor of 2 is applied since the DNEL is derived from a subchronic study.
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the general population is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 3
- Justification:
- An additional factor accounting for a read-across is applied
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:
- 0.4 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):
- 210
- Dose descriptor starting point:
- NOAEL
- Value:
- 84.1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 84.1 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The general-population DNEL long-term for oral route - systemic is derived from the oral NOAEL of 84.1 mg/kg bw/day, obtained in the key Repeated Dose Toxicity Study (similar to OECD TG 409) in Beagle dogs. The NOAELcorr. is calculated as follows:
- absorption (oral, dog) = 50 % (default)
- absorption (oral, human) = 50 % (default)
- experimental exposure time = 7 days/week
- exposure time worker = 7 days/week
--> modified dose descriptor (corrected dermal NOAEL) = 84.1 mg/kg bw/day * (50 %/50 %) * (7 d/7 d) = 84.1 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- Assessment factor of 2 is applied since the DNEL is derived from a subchronic study.
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default allometric scaling factor for the differences between dogs and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the general population is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 3
- Justification:
- An additional factor for using a read-across was applied
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
Identification of relevant dose descriptor
The dose descriptor chosen is the same as for workers (see above). The NOAEL of 84 mg/kg observed in the 90-day repeated dose study in dogs with a structural analogue was used as starting point to derive the DNELs.
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