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Registration Dossier
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EC number: 217-316-1 | CAS number: 1809-19-4
- 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:
- 49 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 225 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Long-term exposure data is available for the inhalation route on a similar substance, however, due to the limitations of the available study the NOAEL is not considered for the calculation of the DNEL. Instead, the NOAEL value used resulted from an animal study whereby the substance was administered orally to rats for 90 days (sub-chronic study) conducted according to the OECD Guideline 408. Route-to-route extrapolation is therefore needed from the oral to the inhalation route. The most sensitive value was identified in the Repeated Dose Toxicity endpoint: the NOAEL for oral, sub-chronic toxicity was set at 500 mg/kg bw/day. The following calculation was performed:
The NOAEL rat is converted to NOAEL human by dividing with the allometric scalling factor 4 for interspecies differences. By multiplying the NOAEL human with the default human body weight (70 kg) and dividing the default human breathing volume referring to workers (10 m3 in 8h and light activity), this dose is then translated into an air concentration. The absorption rate for human via inhalation is not known for the substance. It is assumed that absorption rate via inhalation route is similar to absorption rate via oral route.
NOAELoral= 500 mg/kg b.w
Standard human body weight = 70 kg
Default human breathing volume for workers in 8 hours = 10 m3
A worker is considered to be exposed to 10 m3 for 8 hours per day for 5 days out of 7, therefore, the NOAEC value is multiplied by 10 m3and a factor of 1.4 to account for the length of a work day and for weekends.
Therefore, NOAECinh= (500/4)* (70/10)*1.4 = 1225 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Dose response relationship observed
- AF for differences in duration of exposure:
- 2
- Justification:
- An assessment factor of 2 is applied to allow for differences between a sub-chronic and chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The allometric scaling is already considered
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 5
- Justification:
- AF for intraspecies differences is considered 5 to allow for potential differences in the population of workers
- AF for the quality of the whole database:
- 1
- Justification:
- Good standard of quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- 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:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- 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:
- 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 700 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long-term exposure data is available for the dermal route, however, due to the limitations of the available study the NOAEL is not considered for the calculation of the DNEL. Instead, the NOAEL value used resulted from an animal study whereby the substance was administered orally to rats for 90 days (sub-chronic study) conducted according to the OECD Guideline 408. Route-to-route extrapolation is therefore needed from the oral to the dermal route. The most sensitive value was identified in the Repeated Dose Toxicity endpoint: the NOAEL for oral, sub-chronic toxicity was set at 500 mg/kg bw/day. The following calculation was performed:
- A worker is considered to be exposed to a substance for 5 days out of 7, whereas the test animals are exposed to the substance for 7 days, therefore, the NOAEL value is multiplied by a factor of 1.4.
- The skin absorption value is automatically allocated as 100 % as it satisfies both of the requirements: partition coefficient value from -1 to 4 (log Pow = 1.81); and/or molecular weight below 500 Da (molecular weight = 194.2 Da).
Based on these considerations, the following formula is applied:
NOAELhuman, dermal = NOAELrat, oral × 1.4 / 100 %
Considering the sub-chronic NOAEL value to rats via the oral route was set at 500 mg/kg bw/day, the sub-chronic NOAEL for humans via the dermal route is 700 mg/kg bw/day.
Subsequent assessment factors (AF) are then applied as detailed below. The overall assessment factor was found to be 100.
- AF for dose response relationship:
- 1
- Justification:
- Dose response relationship observed
- AF for differences in duration of exposure:
- 2
- Justification:
- An assessment factor of 2 is applied to allow for differences between a sub-chronic and chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An assessment factor of 4 allows for differences between rats and humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 5
- Justification:
- AF for intraspecies differences is considered 5 to allow for potential differences in the population of workers
- AF for the quality of the whole database:
- 1
- Justification:
- Good standard of quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- 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:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 8.75 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 437.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Long-term exposure data is available for the inhalation route on a similar substance, however, due to the limitations of the available study the NOAEL is not considered for the calculation of the DNEL. Instead, the NOAEL value used resulted from an animal study whereby the substance was administered orally to rats for 90 days (sub-chronic study) conducted according to the OECD Guideline 408. Route-to-route extrapolation is therefore needed from the oral to the dermal route. The most sensitive value was identified in the Repeated Dose Toxicity endpoint: the NOAEL for oral, sub-chronic toxicity was set at 500 mg/kg bw/day. The following calculation was performed:
Route-to-route extrapolation is therefore needed from the oral to the inhalation route.
The NOAEL rat is converted to NOAEL human by dividing with the allometric scalling factor 4 for interspecies differences. By multiplying the NOAEL human with the default human body weight (70 kg) and dividing the default human breathing volume referring to general population (20 m3in 24h and basal caloric demand), this dose is then translated into an air concentration. The absorption rate for human via inhalation is not known for the substance. It is assumed that absorption rate via inhalation route is similar to absorption rate via oral route.
NOAELoral= 500 mg/kg b.w
Standard human body weight = 70 kg
Default human breathing volume for general population in 24 hours = 20 m3
The general populations is considered to be exposed to 20 m3 for 24 hours per day for 7 days.
Therefore, NOAECinh= (500/4)* (70/20) = 437.5 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Dose response relationship observed
- AF for differences in duration of exposure:
- 2
- Justification:
- An assessment factor of 2 is applied to allow for differences between a sub-chronic and chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The allometric scaling is already considered
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 10
- Justification:
- AF for intraspecies differences is considered 10 to allow for potential differences in the general population such as age, health, race
- AF for the quality of the whole database:
- 1
- Justification:
- Good standard of quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- 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:
- repeated dose 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:
- 2.5 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long-term exposure data is available for the dermal route on a similar substance, however, due to the limitations of the available study the NOAEL is not considered for the calculation of the DNEL. Instead, the NOAEL value used resulted from an animal study whereby the substance was administered orally to rats for 90 days (sub-chronic study) conducted according to the OECD Guideline 408. Route-to-route extrapolation is therefore needed from the oral to the dermal route. The most sensitive value was identified in the Repeated Dose Toxicity endpoint: the NOAEL for oral, sub-chronic toxicity was set at 500 mg/kg bw/day. The following calculation was performed:
- The general population is considered to be exposed to a substance for 7 days out of 7.
- The skin absorption value is automatically allocated as 100 % as it satisfies both of the requirements: partition coefficient value from -1 to 4 (log Pow = 1.81); and/or molecular weight below 500 Da (molecular weight = 194.2 Da).
Based on these considerations, the following formula is applied:
NOAELhuman, dermal = NOAELrat, oral
Considering the sub-chronic NOAEL value to rats via the oral route was set at 500 mg/kg bw/day, the sub-chronic NOAEL for humans via the dermal route is 500 mg/kg bw/day.
Subsequent assessment factors (AF) are then applied as detailed below. The overall assessment factor was found to be 200.
- AF for dose response relationship:
- 1
- Justification:
- Dose response relationship observed
- AF for differences in duration of exposure:
- 2
- Justification:
- An assessment factor of 2 is applied to allow for differences between a sub-chronic and chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An assessment factor of 4 allows for differences between rats and humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 10
- Justification:
- AF for intraspecies differences is considered 10 to allow for potential differences in the general population such as age, health, race
- AF for the quality of the whole database:
- 1
- Justification:
- Good standard of quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- 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:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- 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:
- 2.5 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:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL value used resulted from an animal study whereby the substance was administered orally to rats for 90 days (sub-chronic study); the most sensitive value was identified in the Repeated Dose Toxicity endpoint: the NOAEL for oral, sub-acute toxicity was set at 500 mg/kg bw/day.
No route-to-route extrapolation is required.
Subsequent assessment factors (AF) are then applied as detailed below. The overall assessment factor was found to be 200.
- AF for dose response relationship:
- 1
- Justification:
- Dose response relationship observed
- AF for differences in duration of exposure:
- 2
- Justification:
- An assessment factor of 2 is applied to allow for differences between a sub-chronic and chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An assessment factor of 4 allows for differences between rats and humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 10
- Justification:
- AF for intraspecies differences is considered 10 to allow for potential differences in the general population such as age, health, race
- AF for the quality of the whole database:
- 1
- Justification:
- Good standard quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- 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:
- medium 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.
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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