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EC number: 265-634-4 | CAS number: 65212-77-3
- 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:
- 4.7 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 352.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For the calculation of the DNEL the NOAEL of 400 mg/kg bw/day obtained from the reproduction / developmental toxicity screening study in Wistar rats (2011) was used to calculate the inhalatory NOAEC. Therefore, the oral NOAEL was calculated using the default respiratory volume for the rat (0.2 l/min/rat) taking into account the difference between metabolic rate scaling and body weight scaling for rats and humans (allometric scaling factor 4) for an eight hour exposure period.
Oral absorption of the rat and inhalatory absorption of humans was assumed to be both 100%. However, in the absence of information concerning absorption, worst case assumptions have to be made. Therefore, a limited absorption for the starting route leading to a low (conservative) internal NOAEL and maximum absorption for the end route leading to a low external NOAEL shall be assumed. Thus, a default factor of 2 shall be applied.
For workers, the resulting air concentration was additionally corrected for the differences between basal caloric demand (6.7 m³) and caloric demand under light activity (10 m³). This correction factor derives from the inhalative volumes in 8 hours under the respective conditions (6.7 m³ for base level, 10 m³ for light activity). Therefore, the corrected inhalatory NOAEC was calculated as follows:
corrected inhalatory NOAEC = 400 mg/kg * 1 / 0.38 m³/kg bw * 100% / 100% * 6.7 m³/person / 10 m³/person = 705.3 mg/m³ / 2 = 352.6 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- A corrected inhalatory NOAEC was available and thus, no uncertainties in the dose descriptor were assumed.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default assessment value of six was chosen to account for differences in the exposure duration from sub-acute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Differences in metabolic rate were already considered in the calculation of the corrected inhalatory NOAEC
- AF for other interspecies differences:
- 2.5
- Justification:
- Since no studies on toxicokinetics were available, an additional factor of 2.5 for other interspecies differences, such as toxicokinetic differences that are not related to metabolic rate and toxicodynamic differences, was taken into account.
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor taking into account differences in the sensitivity to toxicants in humans (worker).
- AF for the quality of the whole database:
- 1
- Justification:
- No data gaps have been identified and available information was considered sufficient to meet the tonnage driven data requirements.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties were identified.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 1.25 mg/m³
DNEL related information
- DNEL derivation method:
- other: (Technical Rules for Hazardous Substances) TRGS 900
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:
- 13.3 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:
- 400 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For the calculation of the DNEL the NOAEL of 400 mg/kg bw/day obtained from the reproduction/developmental toxicity screening study in Wistar rats (2011) was used to calculate the dermal NOAEL. Oral absorption of the rat was assumed to be 100%, whereas dermal absorption was suggested to be 10% due to a molecular weight of the test substance greater than 500 g/mol (545 g/mol ) and a log P value that was only marginally in the range between -1 and 4 ( ≤ -0.9).
Therefore, the corrected dermal NOAEL was calculated as follows:
corrected dermal NOAEL = 400 mg/kg * 100% / 10% = 4,000 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
1. Identification of relevant dose descriptor
In a 28 d reproduction/developmental toxicity screening study of an analogue substance (methylated) performed in rat (OECD guideline 421), the substance did not cause mortalities, signs of toxicity or changes in body weight or food consumption. The NOAEL is considered to be 400 mg/kg bw/d in males (lower NOAEL, used for calculation of DNEL).
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
3. Application of assessment factors
Allometric scaling: rat to human = 4
Interspecies factor (remaining differences): 2.5
Intraspecies factor: worker = 5, general population = 10
Exposure duration subacute to chronic: 6
Quality of data base: 1
Dose response: 1
10% dermal absorption due to a molecular weight > 500 g/mol and a log Pow > 4 (factor = 0.1)
4. Daily exposure
Worker: exposed for 8h
General population: exposed for 24h
Calculation of DNEL bases upon Guidance Document on Dermal Absorption, European Commission, 2004 and Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, may 2008
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.16 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 174 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For the calculation of the DNEL the NOAEL of 400 mg/kg bw/day obtained from the reproduction / developmental toxicity screening study in Wistar rats (2011) was used to calculate the inhalatory NOAEC. Therefore, the oral NOAEL was calculated using the default respiratory volume for the rat (0.2 l/min/rat) taking into account the difference between metabolic rate scaling and body weight scaling for rats and humans (allometric scaling factor 4) for a 24-hour exposure period (1.15 m³/kg bw).
Oral absorption of the rat and inhalatory absorption of humans was assumed to be both 100%. However, in the absence of information concerning absorption, worst case assumptions have to be made. Therefore, a limited absorption for the starting route leading to a low (conservative) internal NOAEL and maximum absorption for the end route leading to a low external NOAEL shall be assumed. Thus, a default factor of 2 shall be applied.
Therefore, the corrected inhalatory NOAEC was calculated as follows:
corrected inhalatory NOAEC = 400 mg/kg * 1 / 1.15 m³/kg bw * 100% / 100% = 347.8 mg/m³ / 2 = 174.0 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- A corrected inhalatory NOAEC was available and thus, no uncertainties in the dose descriptor were assumed.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default assessment value of six was chosen to account for differences in the exposure duration from sub-acute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Differences in metabolic rate were already considered in the calculation of the corrected inhalatory NOAEC
- AF for other interspecies differences:
- 2.5
- Justification:
- Since no studies on toxicokinetics were available, an additional factor of 2.5 for other interspecies differences, such as toxicokinetic differences that are not related to metabolic rate and toxicodynamic differences, was taken into account.
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor taking into account differences in the sensitivity to toxicants in humans (general population).
- AF for the quality of the whole database:
- 1
- Justification:
- No data gaps have been identified and available information was considered sufficient to meet the tonnage driven data requirements.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties were identified.
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:
- 6.7 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:
- 400 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For the calculation of the DNEL the NOAEL of 400 mg/kg bw/day obtained from the reproduction/developmental toxicity screening study in Wistar rats (2011) was used to calculate the dermal NOAEL. Oral absorption of the rat was assumed to be 100%, whereas dermal absorption was suggested to be 10% due to a molecular weight of the test substance greater than 500 g/mol and a log Pow greater than 4 (factor = 0.1).
Therefore, the corrected dermal NOAEL was calculated as follows:
corrected dermal NOAEL = 400 mg/kg * 100% / 10% = 4,000 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- general population default value
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.67 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:
- 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor necessary because the available NOAEL was obtained from an oral repeated dose toxicity study.
- AF for dose response relationship:
- 1
- Justification:
- The available dose descriptor is already a NOAEL and thus, no AF for dose-response relationship has to be applied.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default assessment value of six was chosen to account for differences in the exposure duration from sub-acute to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default assessment value for alometric scaling from rat to human.
- AF for other interspecies differences:
- 2.5
- Justification:
- Since no studies on toxicokinetics were available, an additional factor of 2.5 for other interspecies differences, such as toxicokinetic differences that are not related to metabolic rate and toxicodynamic differences, was taken into account.
- AF for intraspecies differences:
- 10
- Justification:
- The default assessment value for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- No data gaps have been identified and available information was considered sufficient to meet the tonnage driven data requirements.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties were identified.
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
1. Identification of relevant dose descriptor
In a 28 d reproduction/developmental toxicity screening study of an analogue substance (methylated) performed in rat (OECD guideline 421), the substance did not cause mortalities, signs of toxicity or changes in body weight or food consumption. The NOAEL is considered to be 400 mg/kg bw/d in males (lower NOAEL, used for calculation of DNEL).
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
3. Application of assessment factors
Allometric scaling: rat to human = 4
Interspecies factor (remaining differences): 2.5
Intraspecies factor: worker = 5, general population = 10
Exposure duration subacute to chronic: 6
Quality of data base: 1
Dose response: 1
10% dermal absorption due to a molecular weight > 500 g/mol and a log Pow > 4 (factor = 0.1)
4. Daily exposure
Worker: exposed for 8h
General population: exposed for 24h
Calculation of DNEL bases upon Guidance Document on Dermal Absorption, European Commission, 2004 and Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, may 2008
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