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Registration Dossier
Diss Factsheets
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EC number: 204-555-1 | CAS number: 122-57-6
- 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:
- 7.16 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:
- 145 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 179 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The test substance is a waxy solid with a low vapor pressure (1.34 Pa at 25°C), therefore the exposure hazard via inhalation is unlikely for humans. As no route-specific data are available, a route-to-route extrapolation from an oral repeated dose study in rats (90 days, NTP, 2012) as a worst-case is justified. The oral NOAEL of 145 mg/kg bw/day was corrected for exposure days per week (7d/w to 5d/w; factor *7/5), absorption (assumption according to ECHA Guidance R.8: 50% absorbed oral, 100 % absorbed via inhalation; factor: 1/2), respiratory volume (factor *1/0.38) and respiratory volume for light activity within 8h (6.7m³/10m³; factor * 6.7/10).
corrected NOAEC = 145 mg/kg bw/d / 0.38 m³/kg bw * (6.7 / 10) m³/d * 1/2 * 7d/5d = 178.96 mg/m³.
A corrected NOAEC of 178.96 mg/m³ is derived.
- AF for dose response relationship:
- 1
- Justification:
- Default, as the PoD is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default as allometric scaling is already included in corrected starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is of good quality
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 0.656 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 87.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 65.6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The long-term systemic DNEL for dermal route has been derived from the NOAEL of 87.5 mg/kg bw established in the dermal 3-month study in rats (NTP, 2012). The substance is systemically available by the oral and dermal route and caused decreased body weights and body weight gains and dermal irritation in the treated animals in the two highest dose groups (175 and 350 mg/kg bw). The starting point for the DNEL derivation is the dermal NOAEL.
This NOAEL is corrected for the duration of exposure (6 h in animal test vs. 8 h exposure for workers):
87.5 mg/kg bw/day * 6 h/8 h = 65.63 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default, as the PoD is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is of good quality
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
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:
- 1.26 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 145 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 63.04 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The test substance is a waxy solid with a low vapor pressure (1.34 Pa at 25°C), therefore the exposure hazard via inhalation is unlikely for humans. As no route-specific data are available, a route-to-route extrapolation from an oral repeated dose study in rats (90 days, NTP, 2012) as a worst-case is justified. The oral NOAEL of 145 mg/kg bw/day was corrected for absorption (assumption according to ECHA Guidance R.8: 50% absorbed oral, 100 % absorbed via inhalation; factor: 1/2), and respiratory volume within 24 h (factor * 1/1.15).
corrected NOAEC = 145 mg/kg bw/d / 1.15 m³/kg bw * 1/2 = 63.04 mg/m³.
A corrected NOAEC of 63.04 mg/m³ is derived.
- AF for dose response relationship:
- 1
- Justification:
- Default, as the PoD is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default as allometric scaling is already included in corrected starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default 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:
- No remaining uncertainties
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:
- 78.1 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 87.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15.63 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The long-term systemic DNEL for dermal route has been derived from the NOAEL of 87.5 mg/kg bw established in the dermal 3-month study in rats (NTP, 2012). The starting point for the DNEL derivation is the dermal NOAEL.
This NOAEL is corrected for the duration of exposure (6 h in animal test vs. 24 h exposure for workers; 5 d/week in animal test and 7 days/week for general population):
Corrected NOAEL is 87.5 mg/kg bw/day * 6 h/24 h * 5 d/7 d= 15.63 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default, as the PoD is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default 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:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.725 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:
- 145 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 145 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The oral rat NOAEL of 145 mg/kg bw derived in a subchronic study (NTP, 2012) served as the starting point for the DNEL derivation. The NOAEL was not modified (oral absorption rat = oral absorption human), since no substance- and route specific information on absorption is available.
- AF for dose response relationship:
- 1
- Justification:
- Default, as the PoD is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default 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:
- No remaining uncertainties
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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