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Registration Dossier
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EC number: 931-299-4 | CAS number: 68390-94-3
- 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:
- 35.26 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.58 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral*(1/0.38 m³/kg bw/day)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h)) = 1000 mg/kg bw/day*(1/0.38 m³/kg bw/day)*(0.5/1)*0.67 = 881.58 mg/m³.
In the absence of route-specific information on the starting route, the oral absorption rate is by default considered to be half of that of the inhalation absorption (factor: 0.5/1).
ABSoral-rat = oral absorption rate in rats,
ABSinh-human = inhalation absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- A NOAEL is used as starting point.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on an oral subchronic (90-day) toxicity study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The AF for allometric scaling is already included in ECHA starting point derivation method; no further factor is required.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Database is of good quality.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertanties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 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):
- 100
- 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:
Dermal NOAEL=NOAELoral*(ABSoral-rat/ABSdermal-human) = 1000 mg/kg bw/day*(1/1) = 1000 mg/kg bw/day.
ABSoral-rat = oral absorption rate in rats,
ABSdermal-human = dermal absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- A NOAEL is used as starting point.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on an oral subchronic (90-day) toxicity study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The DNEL is based on a study in rat.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- The database is of good quality.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Since short-term exposure scenarios will not be assessed, only long-term DNELs for workers and the general population will be derived. The oral route is not relevant for workers. In addition it is assumed that only workers will come into contact with the neat substance. Due to the lack of an irritating or sensitising potential of the undiluted test substance the consideration of local DNELs is obsolete.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 434.78 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAECcorr=NOAELoral*(1/1.15 m³/kg/d)*(ABSoral-rat/ABSinh-human) = 1000 mg/kg/d*(1/1.15 m³/kg/d)*(0.5/1) = 434.78 mg/m³.
In the absence of route-specific information on the starting route, the oral absorption rate is by default considered to be half of that of the inhalation absorption (factor: 0.5/1).
ABSoral-rat = oral absorption rate in rats,
ABSinh-human = inhalation absorption rate in humans
- AF for dose response relationship:
- 1
- Justification:
- A NOAEL is used as starting point.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on an oral 90-day study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The AF for allometric scaling is already included in ECHA starting point derivation method; no further factor is required.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- The database is of good quality.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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):
- 200
- 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:
Dermal NOAEL=NOAELoral*( ABSoral-rat/ABSdermal-human) = 1000 mg/kg bw/day*(1/1) = 1000 mg/kg bw/day.
ABSoral-rat = oral absorption rate in rats,
ABSdermal-human = dermal absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- A NOAEL is used as starting point.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on an oral subchronic (90-day) toxicity study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The DNEL is based on a study in rat.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- The database is of good quality.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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):
- 200
- 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 route-to-route extrapolation needed.
- AF for dose response relationship:
- 1
- Justification:
- A NOAEL is used as starting point.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on an oral subchronic (90-day) toxicity study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The DNEL is based on a study in rat.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- The database is of good quality.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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
Since short-term exposure scenarios will not be assessed, only long-term DNELs for workers and the general population will be derived. The oral route is not relevant for workers. In addition it is assumed that only workers will come into contact with the neat substance. Due to the lack of an irritating or sensitising potential of the undiluted test substance the consideration of local DNELs is obsolete.
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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