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Diss Factsheets
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EC number: 429-370-5 | CAS number: 220410-74-2
- 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:
- 9.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on repeated exposure by inhalation. The recommended approach using oral data and assuming the same absorption for inhalation and oral route is used.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidance for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 3
- Justification:
- Intraspecies differences of worker are considered to be fully covered by the selected factor.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- 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:
- 6.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation is necessary since a repeated dose dermal toxicity study is available.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidance for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 3
- Justification:
- Intraspecies differences of worker are considered to be fully covered by the selected factor.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
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:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA REACH Guidance (2010) and ECETOC (2003). In view of the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered to amount each to a value of 1, and are thus not shown in the calculations presented below.
Acute- systemic effects:
The test item is classified and labelled for acute oral toxicity as cat. 4, H302, according to Regulation (EC) No 1272/2008 (CLP) and as Xn, R22 according to Directive 67/548/EEC (DSD). However, no short-term DNEL for systemic effects after oral exposure is derived since oral exposure of workers is not intended. Since the test item is not classified for acute dermal and inhalation toxicity no short-term DNEL was derived.
Acute/short-term and long-term exposure - local effects
Skin irritation/corrosion and sensitization: The test item is not classified for skin irritation/corrosion and skin sensitization according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). Thus, no local DNEL was derived.
Eye irritation: The test item is not classified for eye irritation according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). Thus, no local DNEL was derived.
Respiratory irritation: No effects on respiratory system were observed after short-term inhalation exposure. Furthermore, the test item has no skin or eye irritation potential. The test item is estimated to be not irritating to the respiratory system and therefore no DNEL was derived.
Long-term exposure – systemic effects
Inhalation exposure:
The derived worker DNEL (long-term inhalation exposure) is considered to ensure an appropriate level of protection with regard to acute inhalation exposure (no high peaks of exposure expected). The NOAEL assessed in the 28 day repeated dose oral toxicity study (SLI, 1999) is identified as the relevant dose descriptor.
- Modification of the starting point
Relevant dose descriptor (NOAEL): 100 mg/kg bw/day
Standard respiratory volume of the rat (sRVrat) for 8 hours: 0.38 m³/kg bw/day
Oral absorption of the rat / inhalation absorption of humans (ABSoral-rat / ABSinh-human): 1
Standard respiratory volume of humans (sRVhuman) for 8 hours: 6.7 m³
Worker respiratory volume (wRV) for 8 hours with light physical activity: 10 m³
Corrected inhalatory NOAEC for workers
= 100 mg/kg bw/day × (1 / 0.38 m³/kg bw/day) × 1 × (6.7 m³/10 m³)
= 176.3 mg/m³
- Calculation of the worker DNEL
Corrected inhalatory NOAEC for workers: 176.3 mg/m³
Assessment factor for exposure duration (subacute to chronic): 6
Assessment factor for intraspecies differences (worker): 3
Worker DNEL (long-term inhalation exposure)
= 176.3 mg/m³ / 18
= 9.8 mg/m³
Dermal exposure:
In order to derive the worker DNEL (long-term dermal exposure), the NOAEL assessed in the 90 day repeated dose dermal toxicity study (CIT, 2007) is identified as the relevant dose descriptor. Considering the appropriate modification and assessment factors, the worker DNEL (long-term dermal exposure) is calculated as follows:
Relevant dose descriptor (NOAEL): 150 mg/kg bw/day
Exposure duration factor (subchronic-to-chronic): 2
Allometric scaling factor (rat-to-human): 4
Assessment factor for intraspecies differences (worker): 3
Worker DNEL (long-term dermal exposure)
= 150 mg/kg bw/day / (2 × 4 × 3)
= 6.25 mg/kg bw/day
References
(not included as endpoint study record)
- ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health.Version 2. ECHA-2010 -G-19 –EN.
- ECETOC (2010). Technical Report 110. Guidance on assessment factors to derive a DNEL.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 86.96 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on repeated exposure by inhalation. The recommended approach using oral data and assuming the same absorption for inhalation and oral route is used.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidance for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies differences of general population are considered to be fully covered by the selected factor.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute 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:
- 3.75 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation is necessary since a repeated dose dermal toxicity study is available.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidance for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies differences of general population are considered to be fully covered by the selected factor.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
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:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation is necessary since a repeated dose oral toxicity study is available.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics.
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies differences of general population are considered to be fully covered by the selected factor.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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
General
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA REACH Guidance (2010) and ECETOC (2003). In view of the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered to amount each to a value of 1, and are thus not shown in the calculations presented below.
Long-term exposure – systemic effects
Inhalation exposure:
The derived general population DNEL (long-term inhalation exposure) is considered to ensure an appropriate level of protection with regard to acute inhalation exposure (no high peaks of exposure expected). The NOAEL assessed in the 28-day repeated dose oral toxicity study (SLI, 1999) is identified as the relevant dose descriptor.
- Modification of the starting point
Relevant dose descriptor (NOAEL): 100 mg/kg bw/day
Standard breathing volume rat (24 h): 1.1.5 m3/kg
Oral absorption of the rat / inhalation absorption of humans (ABSoral-rat / ABSinh-human): 1
Corrected inhalatory NOAEC for general population
= (100 mg/kg bw/day / 1.15 m3/kg/d *1
= 86.96 mg/m³
- Calculation of the general population DNEL
Corrected inhalatory NOAEC for workers: 86.96 mg/m³
Assessment factor for exposure duration (subacute to chronic): 6
Assessment factor for intraspecies differences (general population): 5
General population DNEL (long-term inhalation exposure)
= 86.96 mg/m³ / (6 × 5)
= 2.9 mg/m³
Dermal exposure:
In order to derive the general population DNEL (long-term dermal exposure), the NOAEL assessed in the 90-day repeated dose dermal toxicity study (CIT, 2007) is identified as the relevant dose descriptor. Considering the appropriate modification and assessment factors, the general population DNEL (long-term dermal exposure) is calculated as follows:
Relevant dose descriptor (NOAEL): 150 mg/kg bw/day
Exposure duration factor (subchronic-to-chronic): 2
Allometric scaling factor (rat-to-human): 4
Assessment factor for intraspecies differences (general population): 5
General population DNEL (long-term dermal exposure)
= 150 mg/kg bw/day / (2 × 4 × 5)
= 3.75 mg/kg bw/day
Oral exposure:
The test item is classified and labelled for acute systemic toxicity after oral exposure, according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). However, no DNEL is derived since no peak exposure of the general population via oral route is expected.
In order to derive the general population DNEL (long-term oral exposure), the NOAEL assessed in the 28-day repeated dose oral toxicity study (SLI, 1999) is identified as the relevant dose descriptor. Considering the appropriate modification and assessment factors, the general population DNEL (long-term oral exposure) is calculated as follows:
Relevant dose descriptor (NOAEL): 100 mg/kg bw/day
Exposure duration factor (subacute-to-chronic): 6
Allometric scaling factor (rat-to-human): 4
Assessment factor for intraspecies differences (general population): 5
General population DNEL (long-term dermal exposure)
= 100 mg/kg bw/day / (6 × 4 × 5)
= 0.8 mg/kg bw/day
References
(not included as endpoint study record)
- ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2. ECHA-2010 -G-19 –EN.
- ECETOC (2010). Technical Report 110. Guidance on assessment factors to derive a DNEL.
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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