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Registration Dossier
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EC number: 203-630-6 | CAS number: 108-93-0
- 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:
- 40.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 2 007.2 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 008.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEC of 500 ppm for parental and foetotoxic effects determined over two generations in the rat 2-generation reproductive toxicity (inhalation) study was used, which corresponds to a concentration of 2007.2 mg/m3. Modification of the starting point due to the differences in respiratory volume for workers (*6.7 m3/10 m3) and the differences in the time of exposure (*6 h/8 h) yields a modified starting point of 1008.6 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Dose descriptor of starting point is NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- According to the ECHA guidance (Chapter R.8), allometric scaling should not be applied in cases where inhalation doses are expressed as concentrations, as these are assumed to be already scaled according to the allometric principle
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default value (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Starting point was a robust read-across from cyclohexanone data obtained for the inhalation route, which is considered most relevant with regards to human exposure to cyclohexanol
- AF for remaining uncertainties:
- 1
- Justification:
- No further AF considered necessary
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.43 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:
- 143 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 143 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 143 mg/kg bw/d determined in the 90-day repeated dose toxicity (oral) study in the rat was used. Modification of the starting point was not necessary on the assumption that dermal absorption will not be higher than oral absorption and on the fact that exposure time is not relevant when the toxic effects are mainly driven by the exposure concentration.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (rat to human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Starting point was a robust read-across from cyclohexanone data
- AF for remaining uncertainties:
- 1
- Justification:
- No further AF considered necessary
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 2 007.2 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 501.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEC of 500 ppm determined in the rat 2-generation reproductive toxicity (inhalation) study was used, which corresponds to a concentration of 2007.2 mg/m3. Modification of the starting point due to the differences in the time of exposure (*6 h/24 h) yields a modified starting point of 501.8 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Dose descriptor of starting point is NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- According to the ECHA guidance (Chapter R.8), allometric scaling should not be applied in cases where inhalation doses are expressed as concentrations, as these are assumed to be already scaled according to the allometric principle
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 10
- Justification:
- Default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Starting point was a robust read-across from cyclohexanone data obtained for the inhalation route, which is considered most relevant with regards to human exposure to cyclohexanol
- AF for remaining uncertainties:
- 1
- Justification:
- No further AF considered necessary
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.716 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:
- 143 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 143 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 143 mg/kg bw/d determined in the 90-day repeated dose toxicity (oral) study in the rat was used. Modification of the starting point was not necessary on the assumption that dermal absorption will not be higher than oral absorption and the on the fact that exposure time is not relevant when the toxic effect is mainly driven by the exposure concentration.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (rat to human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 10
- Justification:
- Default value (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Starting point was a robust read-across from cyclohexanone data
- AF for remaining uncertainties:
- 1
- Justification:
- No further AF considered necessary
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.716 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:
- 143 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 143 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 143 mg/kg bw/d determined in the 90-day repeated dose toxicity (oral) study in the rat was used. Modification of the starting point was not necessary based on same route of exposure and on the fact that exposure time is not relevant when the toxic effect is mainly driven by the exposure concentration.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (rat to human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 10
- Justification:
- Default value (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Starting point was a robust read-across from cyclohexanone data
- AF for remaining uncertainties:
- 1
- Justification:
- No further AF considered necessary
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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.
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