Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 289-200-9 | CAS number: 86178-38-3
- 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:
- 16.45 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 234 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to ECHA Guidance – Chapter R8 (p25): “in the absence of route-specific information on the starting route, to include a default factor of 2 (i.e. the absorption percentage for the starting route is half that the end route) in the case of oral-to inhalation extrapolation”. Therefore, as no data is available on oral or inhalation absorption, the oral absorption is estimated to 50% and the inhalation absorption to 100%. The correction factor is 0.5 (50/100).
Correction factor for differences in respiratory volume (rat/workers): 1/0.38
Correction factor for light activity at work : 6.7/10
Correction factor for difference between human and experimental exposure conditions : 7/5 (In the study, animals were exposed 7 days per week, and workers work 5 days per week).
NOAEC = NOAEL x (1/0.38) x (6.7/10) x 0.5 x 7/5 = 1000 x (1/0.38) x (6.7/10) x 0.5 x 7/5 = 1234 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- This factor is applied because the dose-descriptor starting point is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on a subacute study (28-day).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is applied for remaining difference.
- AF for intraspecies differences:
- 5
- Justification:
- A factor of 5 is applied for worker DNELs.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor 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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 46.7 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 14 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The oral and dermal absorption are considered to be 100% and 10% respectively.
Correction factor for difference between human and experimental exposure conditions : 7/5 (In the study, animals were exposed 7 days per week, and workers work 5 days per week)
Corrected NOAEL = NOAEL (oral) x [oral absorption] / [dermal absorption] x 7/5 = 1000 x 100/10 x 7/5= 14000 mg/kg bw
- AF for dose response relationship:
- 1
- Justification:
- This factor is applied because the dose-descriptor starting point is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on a subacute study (28-day).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 must be applied because the key study was performed on rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is applied for remaining difference.
- AF for intraspecies differences:
- 5
- Justification:
- A factor of 5 is applied for worker DNELs.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is applied.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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:
- 2.9 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 435 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to ECHA Guidance – Chapter R8 (p25): “in the absence of route-specific information on the starting route, to include a default factor of 2 (i.e. the absorption percentage for the starting route is half that the end route) in the case of oral-to inhalation extrapolation”. Therefore, as no data is available on oral or inhalation absorption, the oral absorption is estimated to 50% and the inhalation absorption to 100%. The correction factor is 0.5 (50/100). NOAEC = NOAEL x (1/1.15) x 0.5 = 435 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- This factor is applied because the dose-descriptor starting point is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on a subacute study (28-day).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is applied for remaining difference.
- AF for intraspecies differences:
- 10
- Justification:
- A factor of 10 is applied for the general population DNELs.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is applied.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No hazard has been identified due to lack of data for this endpoint/effect in the dataset in compliance to REACH Annexes data requirements. Thus it is impossible to propose a hazard assessment.
No acute inhalation test is available on the registered substance.
However, based on the low vapour pressure of the substance and no spraying uses, no hazard is expected by inhalation.
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:
- 16.7 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The dermal and oral absorption are considered to be 100% and 10% respectively.
NOAEL (dermal) = NOAEL (oral) x 100 /10 = 10000 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- This factor is applied because the dose-descriptor starting point is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on a subacute study (28-day).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 must be applied because the key study was performed on rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is applied for remaining difference.
- AF for intraspecies differences:
- 10
- Justification:
- A factor of 10 is applied for the general population DNELs.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is applied.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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:
- 1.67 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No difference in oral absorption is expected between rats and humans.
- AF for dose response relationship:
- 1
- Justification:
- This factor is applied because the dose-descriptor starting point is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on a subacute study (28-day).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 must be applied because the key study was performed on rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is applied for remaining difference.
- AF for intraspecies differences:
- 10
- Justification:
- A factor of 10 is applied for the general population DNELs.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is applied.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
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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