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Registration Dossier
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EC number: 907-434-8 | 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:
- 5.81 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 165 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 145.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
From 2 Generation study, a conservative NOAEL of 3300 ppm for F2 generation has been chosen for derivation of DNELs. Upon conversion of ppm to mg/kg a NOAEL of 165 mg/kg has been derived by applying factor of 20 (Ref: Table 2.2 conversion factors, Pocket Handbook of toxicology).
For modifying the dose descriptor, the factor of 0.38 was applied for conversion of mg/kg to mg/m³. A factor of 6.7 and 10 for respiratory volumes were applied. 50% bioavailibity has been selected for route to route extrapolation value.
Corrected NOAEC = 165 mg/kg bw/day * (1/0.38 m³/mg/kg bw/day) x 0.67 x 0.5 = 145.4 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- default (no uncertainties in the dose descriptor = NOAEL/NOAEC)
- AF for differences in duration of exposure:
- 2
- Justification:
- default for subchronic-to-chronic (second generation (until the weaning) NOAEL was selected for DNEL calculation)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default for inhlation-to-inhalation (no additional assessment factor for allometric scaling is necessary, since the interspecies differences have already been taken into account (delineation of corrected NOAEC))
- AF for other interspecies differences:
- 2.5
- Justification:
- default (a standard procedure to correct for differences in metabolic rate and differences in toxicokinetics and toxicodynamics)
- AF for intraspecies differences:
- 5
- Justification:
- default assessment factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- default (no remaining uncertainties in the derived DNEL)
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties to account for.
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:
- 693 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 165 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 693 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
From 2 Generation study, a conservative NOAEL of 3300 ppm for F2 generation has been chosen for derivation of DNELs. Upon conversion of ppm to mg/kg a NOAEL of 165 mg/kg has been derived by applying factor of 20 (Ref: Table 2.2 conversion factors , Pocket Handbook of toxicology). The same NOAEL has been chosen for DNEL dermal calculation.
For modifying the dose descriptor, the default dermal absorption factor of 100% is applied.
Furthermore the NOAEL is corrected for duration of exposure (24 h in the rats versus 8 h in workers - and - 7 days in the rat versus 5 days in workers)
Corr. NOAEL = 165 mg/kg bw/day * (24h/8h) * (7 d/ 5 d) = 693 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default (no uncertainties in the dose descriptor = NOAEL/NOAEC)
- AF for differences in duration of exposure:
- 2
- Justification:
- default for subchronic-to-chronic (second generation (until the weaning) NOAEL was selected for DNEL calculation)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default - Allometric scalling factor for systemic effects oral to dermal for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- default (a standard procedure to correct for differences in metabolic rate and differences in toxicokinetics and toxicodynamics)
- AF for intraspecies differences:
- 5
- Justification:
- default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- default (no remaining uncertainties in the derived DNEL)
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties to account for.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.434 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 165 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 71.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
From 2 Generation study, a conservative NOAEL of 3300 ppm for F2 generation has been chosen for derivation of DNELs. Upon conversion of ppm to mg/kg a NOAEL of 165 mg/kg has been derived by applying factor of 20 (Ref: Table 2.2 conversion factors, Pocket Handbook of toxicology).
For modifying the dose descriptor, the factor of 1.15 was applied for conversion of mg/kg to mg/m³. 50% bioavailibity has been selected for route to route extrapolation value.
Corrected NOAEC = 165 mg/kg bw/day * (1/1.15 m³/mg/kg bw/day) x 0.5 = 71.7 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- default (no uncertainties in the dose descriptor = NOAEL/NOAEC)
- AF for differences in duration of exposure:
- 2
- Justification:
- default for subchronic-to-chronic (second generation (until the weaning) NOAEL was selected for DNEL calculation)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default for inhlation-to-oral (no additional assessment factor for allometric scaling is necessary, since the interspecies differences have already been taken into account (delineation of corrected NOAEC))
- AF for other interspecies differences:
- 2.5
- Justification:
- default (a standard procedure to correct for differences in metabolic rate and differences in toxicokinetics and toxicodynamics)
- AF for intraspecies differences:
- 10
- Justification:
- default assessment factor for consumer, intraspecies variability
- AF for the quality of the whole database:
- 1
- Justification:
- default (no remaining uncertainties in the derived DNEL)
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties to account for.
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:
- 0.825 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 165 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 165 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
From 2 Generation study, a conservative NOAEL of 3300 ppm for F2 generation has been chosen for derivation of DNELs. Upon conversion of ppm to mg/kg a NOAEL of 165 mg/kg has been derived by applying factor of 20 (Ref: Table 2.2 conversion factors, Pocket Handbook of toxicology).
For modifying the dose descriptor, the factor of 100 % bioavailibity has been selected. Default value for route to route extrapolation is 100%
Corrected NOAEC = 165 mg/kg bw/day * (100%/100%) = 165 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- default (no uncertainties in the dose descriptor = NOAEL/NOAEC)
- AF for differences in duration of exposure:
- 2
- Justification:
- default for subchronic-to-chronic (second generation (until the weaning) NOAEL was selected for DNEL calculation)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default - Allometric scalling factor for systemic effects oral to dermal for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- default (a standard procedure to correct for differences in metabolic rate and differences in toxicokinetics and toxicodynamics)
- AF for intraspecies differences:
- 10
- Justification:
- default assessment factor for consumer, intraspecies variability
- AF for the quality of the whole database:
- 1
- Justification:
- default (no remaining uncertainties in the derived DNEL)
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties to account for.
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:
- 0.825 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 165 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 165 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
From 2 Generation study, a conservative NOAEL of 3300 ppm for F2 generation has been chosen for derivation of DNELs. Upon conversion of ppm to mg/kg a NOAEL of 165 mg/kg has been derived by applying factor of 20 (Ref: Table 2.2 conversion factors, Poclet Handbook of toxicology). The same NOAEL has been chosen for DNEL consumer oral calculation.
For modifying the dose descriptor, the factor of 100 % bioavailibity (oral to oral) has been selected. Default values for route to route extrapolation is 100%
Corrected NOAEC = 165 mg/kg bw/day * (100%/100%) = 165 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- default (no uncertainties in the dose descriptor = NOAEL/NOAEC)
- AF for differences in duration of exposure:
- 2
- Justification:
- default for subchronic-to-chronic (second generation (until the weaning) NOAEL was selected for DNEL calculation)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default - Allometric scalling factor for systemic effects oral to oral for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- default (a standard procedure to correct for differences in metabolic rate and differences in toxicokinetics and toxicodynamics)
- AF for intraspecies differences:
- 10
- Justification:
- default assessment factor for consumer, intraspecies differences
- AF for the quality of the whole database:
- 1
- Justification:
- default (no remaining uncertainties in the derived DNEL)
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties to account for.
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
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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