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Diss Factsheets
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EC number: 309-496-6 | CAS number: 100402-60-6
- 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:
- 416 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: see discussion
- Overall assessment factor (AF):
- 16.8
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 750 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The relevant oral NOAEL of 1000 mg/kg bw/d is converted into a corrected NOAEC assuming a standard 6h respiratory volume of 0.38 m³/kg for the rat, a standard 8h respiratory volume of 6.7 m³/Person for humans and a respiratory volume light activity of 10 m³/person for workers.
- AF for dose response relationship:
- 1
- Justification:
- No indication for any effect level that could differ between humans and test species and which are not accounted for in the other AF.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- standard factor according to ECHA guideline.
- AF for other interspecies differences:
- 1
- Justification:
- Allometric AF accounts for all interspecies differences.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC assessment factor
- AF for the quality of the whole database:
- 1
- Justification:
- standard factor according to ECHA guideline.
- AF for remaining uncertainties:
- 1
- Justification:
- It has been shown that an additional assessment factor for remaining uncertainties is scientifically unjustified ( Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129)
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)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 59.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: see discussion
- Overall assessment factor (AF):
- 16.8
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- as a worst case, oral and dermal bioavailability is considered to be equal. Structure and molecular weight suggest that dermal penetration actually should be lower than oral uptake.
- AF for dose response relationship:
- 1
- Justification:
- No indication for any effect level that could differ between humans and test species and which are not accounted for in the other AF.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA standard AF
- AF for other interspecies differences:
- 1
- Justification:
- Allometric AF accounts for all interspecies differences.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC AF for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- standard factor according to ECHA guideline.
- AF for remaining uncertainties:
- 1
- Justification:
- Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
DNEL - long-term exposure - systemic effects oral:
The key study for DNEL derivation is a subchronic oral toxicity study in rats with the registered substance, suggesting a NOAEL of 1000 mg/kg bw/d. The following assessment factors are proposed for the oral DNEL for workers: 4 for allometric scaling, 3 for intraspecies variation, and 1.4 for exposure extrapolation (subchronic to chronic) resulting in an overall assessment factor of 16.8. An additional factor for “remaining interspecies differences” as proposed by ECHA is scientifically not justified since the allometric scaling factor fully accounts for interspecies differences. This has recently independently been confirmed by the German BAuA (BAuA Bekanntmachung 901 “Kriterien zur Ableitung von Arbeitsplatzgrenzwerten” April 2010,GMBl 2010 Nr. 32 S. 691-696) and theECETOC Assessment Factor Working Group (ECETOC Technical Report in preparation: Guidance on Assessment Factors to Derive DNELs (2010)). It had been shown recently that the assessment factor for time extrapolation from subchronic to chronic exposure actually is 1.4 (but not 2) when the statistical bias is removed from the dataset ( Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129). Based on these assessment factors, the long-term exposure DNEL for oral exposure for workers is 59.5 mg/kg bw/d.
DNEL - long-term exposure - systemic effects dermal:
The key study for DNEL derivation is a subchronic oral toxicity study in rats with the registered substance, suggesting a NOAEL of 1000 mg/kg bw/d. The following assessment factors are proposed for the dermal DNEL for workers: 4 for allometric scaling, 3 for intraspecies variation because the registered substance is exclusively used in professional and industrial settings, and 1.4 for exposure extrapolation (subchronic to chronic) resulting in an overall assessment factor of 16.8. Equal absorption via the oral and dermal route is assumed based on structure considerations. An additional factor for “remaining interspecies differences” as proposed by ECHA is scientifically not justified since the allometric scaling factor fully accounts for interspecies differences. This has recently independently been confirmed by the German BAuA (BAuA Bekanntmachung 901 “Kriterien zur Ableitung von Arbeitsplatzgrenzwerten” April 2010,GMBl 2010 Nr. 32 S. 691-696) and theECETOC Assessment Factor Working Group (ECETOC Technical Report in preparation: Guidance on Assessment Factors to Derive DNELs (2010)). Furthermore, it had been shown recently that the assessment factor for time extrapolation from subchronic to chronic exposure is 1.4 (but not 2) when the statistical bias is removed from the dataset (Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129). Based on these assessment factors, the long-term exposure DNEL for dermal exposure for workers is 59.5 mg/kg bw/d.
DNEL - long-term exposure - systemic effects inhalation:
For inhalation the relevant oral NOAEL of 1000 mg/kg bw/d is converted into a corrected NOAEC assuming a standard 6h respiratory volume of 0.38 m³/kg for the rat, a standard 8h respiratory volume of 6.7 m³/Person for humans, a body weight of 70 kg and a respiratory volume light activity of 10 m³/person for workers. This results in a corrected NOAEC of 1750 mg/m³. Taking in account assessment factors of 1 for interspecies differences (inhalation), 3 for intraspecies variation (worker), and 1.4 for exposure time extrapolation (subchronic to chronic) the long-term exposure DNEL for inhalation is 416 mg/m³.Equal absorption via both routes is assumed.
Local Effects
Local effects were not observed in any investigation, therefore local DNELs may not be derived.
Acute/short term exposure
The registered substance is neither irritating to the skin or the eyes and it is not a sensitizer. Therefore, acute DNELs may not be derived.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 125 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: see discussion
- Overall assessment factor (AF):
- 28
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 875 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- For inhalation the relevant oral NOAEL of 1000 mg/kg bw/d is converted into a corrected NOAEC assuming a standard body weight of 70 kg, an allometric scaling factor (rat-human) of 4 and a respiratory volume of 20 m³/person for the general population.
- AF for dose response relationship:
- 1
- Justification:
- ECHA guidance default. No indication for any effect level that could differ between humans and test species and which are not accounted for in the other AF.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA guidance default.
- AF for other interspecies differences:
- 1
- Justification:
- Allometric AF accounts for all interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC default for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA guidance default.
- AF for remaining uncertainties:
- 1
- Justification:
- Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129
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)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: see discussion
- Overall assessment factor (AF):
- 28
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- As a worst case, oral and dermal bioavailability is considered to be equal. Structure and molecular weight suggest that dermal penetration actually should be lower than oral uptake.
- AF for dose response relationship:
- 1
- Justification:
- ECHA guidance default. No indication for any effect level that could differ between humans and test species and which are not accounted for in the other AF.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default AF.
- AF for other interspecies differences:
- 1
- Justification:
- Allometric AF accounts for all interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC default AF for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default AF.
- AF for remaining uncertainties:
- 1
- Justification:
- Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
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:
- DNEL (Derived No Effect Level)
- Value:
- 35.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: see discussion
- Overall assessment factor (AF):
- 28
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- not necessary.
- AF for dose response relationship:
- 1
- Justification:
- ECHA guidance default. No indication for any effect level that could differ between humans and test species and which are not accounted for in the other AF.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default AF.
- AF for other interspecies differences:
- 1
- Justification:
- Allometric AF accounts for all interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC default AF.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default AF.
- AF for remaining uncertainties:
- 1
- Justification:
- Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129
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
Acute/short term exposure
The registered substance is neither irritating to the skin or the eyes and it is not a sensitizer. Therefore, acute DNELs may not be derived.
Local effects
Local effects were not observed in any investigation, therefore local DNELs may not be derived.
DNEL - long-term exposure - systemic effects oral:
The key study for DNEL derivation is a subchronic oral toxicity study in rats with the registered substance, suggesting a NOAEL of 1000 mg/kg bw/d. The following assessment factors are proposed for the oral DNEL for workers: 4 for allometric scaling, 5 for intraspecies variation (general population), and 1.4 for exposure extrapolation (subchronic to chronic) resulting in an overall assessment factor of 28. An additional factor for “remaining interspecies differences” as proposed by ECHA is scientifically not justified since the allometric scaling factor fully accounts for interspecies differences. This has recently independently been confirmed by the German BAuA (BAuA Bekanntmachung 901 “Kriterien zur Ableitung von Arbeitsplatzgrenzwerten” April 2010,GMBl 2010 Nr. 32 S. 691-696) and theECETOC Assessment Factor Working Group (ECETOC Technical Report in preparation: Guidance on Assessment Factors to Derive DNELs (2010)). It had been shown recently that the assessment factor for time extrapolation from subchronic to chronic exposure actually is 1.4 (but not 2) when the statistical bias is removed from the dataset (Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129). Based on these assessment factors, the long-term exposure DNEL for oral exposure for workers is 35.7 mg/kg bw/d.
DNEL - long-term exposure - systemic effects inhalation:
For inhalation the relevant oral NOAEL of 1000 mg/kg bw/d is converted into a corrected NOAEC assuming a standard body weight of 70 kg, an allometric scaling factor (rat-human) of 4 and a respiratory volume of 20 m³/person for the general population. This results in a corrected NOAEC of 875 mg/m³. Taking in account assessment factors of 1 for interspecies differences (inhalation), 5 for intraspecies variation (general population), and 1.4 for exposure time extrapolation (subchronic to chronic) the long-term exposure DNEL for inhalation is 125 mg/m³.Equal absorption via both routes is assumed.
DNEL - long-term exposure - systemic effects dermal:
The key study for DNEL derivation is a subchronic oral toxicity study in rats with the registered substance, suggesting a NOAEL of 1000 mg/kg bw/d. The following assessment factors are proposed for the dermal DNEL for workers: 4 for allometric scaling, 5 for intraspecies variation because the registered substance is exclusively used in professional and industrial settings, and 1.4 for exposure extrapolation (subchronic to chronic) resulting in an overall assessment factor of 28. Equal absorption via the oral and dermal route is assumed based on structure considerations. An additional factor for “remaining interspecies differences” as proposed by ECHA is scientifically not justified since the allometric scaling factor fully accounts for interspecies differences. This has recently independently been confirmed by the German BAuA (BAuA Bekanntmachung 901 “Kriterien zur Ableitung von Arbeitsplatzgrenzwerten” April 2010,GMBl 2010 Nr. 32 S. 691-696) and theECETOC Assessment Factor Working Group (ECETOC Technical Report in preparation: Guidance on Assessment Factors to Derive DNELs (2010)). Furthermore, it had been shown recently that the assessment factor for time extrapolation from subchronic to chronic exposure is 1.4 (but not 2) when the statistical bias is removed from the dataset (Batke et al., Derivation of sound time extrapolation factors for repeated dose toxicity studies using RepDose. Toxicology Letters 205 (2011) 122– 129). Based on these assessment factors, the long-term exposure DNEL for dermal exposure for workers is 35.7 mg/kg bw/d
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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