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EC number: 246-619-1 | CAS number: 25103-58-6
- 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:
- 4.2 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:
- 207 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 104 mg/m³
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation is based on a 90-day toxicity study by inhalation administration to rats (TNO 2017). The starting concentration for DNEL calculation is a NOAEC of 207 mg/m3 (25.1 ppm). The NAEC (8h) derived for workers is 104 mg/m3 (207 mg/m3 x 6h/8h x 6.7 m3/10 m3) after correction for difference in exposure conditions and between respiratory rates under standard conditions and under conditions of light activity.
- AF for dose response relationship:
- 1
- Justification:
- This factor is applied because the dose-descriptor starting point is a NOAEC.
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on a subchronic study (90-day).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation. Allometric scaling is implicitly taken into account in the factor for remaining differences.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is applied for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- A factor of 5 is applied for worker DNELs.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is applied.
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:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 350 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal DNEL derivation is based on the oral extended one generation reproduction toxicity study (OECD 443, CRL 2021) because the extrapolation between oral and dermal routes is more relevant that the dermal and inhalation routes based on the toxicokinetics.
The starting dose for the dermal DNEL calculation is an oral NOAEL of 25 mg/kg/day.
Based on the TK assessment, a dermal absorption of 10% and an oral absorption of 100% were used.
Correction factor for difference between human and experimental exposure conditions : 7/5 (In the study, animals were exposed 7 days per week, and workers work 5 days per week).
Dermal NOAEL = oral NOAEL x 100/10 x 7/5= 25 x 100/10 x 7/5 = 350 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- This factor is applied because the dose-descriptor starting point is a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on a subchronic study : in the EOGRTS, males and females were exposed at least 16 weeks.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 must be applied because the key study was performed on rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is applied for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- A factor of 5 is applied for worker DNELs.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is applied.
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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:
- 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:
- 0.74 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):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 207 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 37 mg/m³
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation is based on a 90-day toxicity study by inhalation administration to rats (TNO 2017). The starting dose for DNEL calculation is a NOAEC of 207 mg/m3. The NOAEC (24h) derived for the general population is 37 mg/m3 (207 mg/m3 x 6h/24h x 5d/7d) after correction for difference in exposure conditions.
- AF for dose response relationship:
- 1
- Justification:
- This factor is applied because the dose-descriptor starting point is a NOAEC.
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on a subchronic study (90-day).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation. Allometric scaling is implicitly taken into account in the factor for remaining differences.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is applied for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- A factor of 10 is applied for the general population DNELs.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is applied.
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:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- irritation (respiratory tract)
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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal DNEL derivation is based on the oral extended one generation reproduction toxicity study (OECD 443, CRL 2021) because the extrapolation between oral and dermal routes is more relevant that the dermal and inhalation routes based on the toxicokinetics.
The starting dose for the dermal DNEL calculation is an oral NOAEL of 25 mg/kg/day.
Based on the TK assessment, a dermal absorption of 10% and an oral absorption of 100% were used.
Dermal NOAEL = oral NOAEL x 100/10 = 25 x 100/10 = 250 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- This factor is applied because the dose-descriptor starting point is a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on a subchronic study : in the EOGRTS, males and females were exposed at least 16 weeks
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 must be applied because the key study was performed on rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is applied for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- A factor of 5 is applied for worker DNELs.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is applied.
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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:
- 0.25 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:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Oral DNEL derivation is based on the oral extended one generation reproduction toxicity study (OECD 443, CRL 2021), the most longer oral exposure study.
No difference between the oral absorption in rat and human is expected.
- AF for dose response relationship:
- 1
- Justification:
- This factor is applied because the dose-descriptor starting point is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on a subchronic study : in the EOGRTS, males and females were exposed at least 16 weeks
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 must be applied because the key study was performed on rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is applied for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- A factor of 10 is applied for the general population DNELs.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is applied.
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
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