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EC number: 614-657-1 | CAS number: 68609-08-5
- 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:
- 3.29 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 247 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by inhalation. A conservative approach is used by performing a route-to-route extrapolation. Please refer to the discussion.
- 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:
- An extrapolation factor is needed since a subacute study is available.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling factor is applied because an oral-to-inhalation route extrapolation is performed.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 9.87 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
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:
- 1.87 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 560 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure. Taken into account the physico-chemical properties of the substance, dermal absoption is anticipated to be 50 % of oral absorption. For details refer to the discussion.
- 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:
- An extrapolation factor is needed since a subacute study is available.
- 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:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- 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:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General
DNEL derivation for the test substance is performed under consideration of the recommendations of ECHA. 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.
Workers – Hazard via inhalation route
Long term systemic inhalation DNEL, worker
Calculation of dose descriptor
Step 1: Selection of the relevant dose descriptor (starting point):
For risk characterisation an inhalation NOAEC was derived by route to route extrapolation.
The oral NOAEL of 200 mg/kg bw/day, obtained from subacute toxicity testing in rats, was considered as key value for the chemical safety assessment and therefore, most relevant starting point.
Step 2: Modification into a correct starting point:
Standard respiratory volume, human (sRVhuman) for 8 hours: 6.7 m3
Standard respiratory volume of the rat (sRVrat) for 8 hours: 0.38 m3/kg bw
Worker respiratory volume (wRV) for 8 hours with light physical activity: 10 m3
Oral absorption of the rat/ inhalation absorption of humans (ABS oral-rat / ABS inh-human): 50 %/100 % (default)
Correction for difference between human and experimental exposure conditions: 7 d rat/5 d worker
Corrected NOAEC (inhalation) for workers:
= 200 mg/kg bw/day x 0.5 x 1/0.38 m3/kg bw/day x (6.7 m3/10 m3) x 1.4
= 247 mg/m3
Step 3: Use of assessment factors: 75
Interspecies: no allometric scaling factor is applied because an oral-to-inhalation route extrapolation is performed.
Interspecies AF, remaining differences: 2.5
Intraspecies AF (worker): 5
AF for differences in duration: 6
In conclusion the long term systemic inhalation DNEL workers was calculated to be 3.29 mg/m³ bw/day.
Short term inhalation DNEL, worker
No study for acute inhalation toxicity is availabe. As the substance is classified as acute toxic (oral) Cat 4 acute inhalation toxicity can not be excluded and acute inhalation DNEL is derived. The acute inhalation DNEL was based on long-term inhalation DNEL. The acute inhalation DNEL was calculated as 3 times the value of the corresponding long-term DNEL (ECHA CSR R.8, 2012). Thus, worker DNEL acute inhalation = 3 x 3.29 mg/m3/day = 9.84 mg/m3.
Local effects
No data on respiratory irritation is available. As the substance is not classified as skin and eye irritating also no adverse effects on respiratory system is expected (in accordance with "Guidance on information requirements and chemical safety assessment, chapter R.8"). Based on the physical parameters a peak exposure is not expected. Thus, no DNEL and no qualitative risk assessment is required.
Workers – Hazard via dermal route
Long term systemic dermal DNEL, worker
Calculation of dose descriptor
Step 1: Selection of the relevant dose descriptor (starting point):
For risk characterisation a dermal NOAEL was derived by route to route extrapolation.
The oral NOAEL of 200 mg/kg bw/day, obtained from subacute repeated dose oral toxicity testing in rats was considered as key value for the chemical safety assessment and therefore, most relevant starting point.
Step 2: Modification into a correct starting point:
Based on the physical chemical properties of the substance (low to moderate water solubility, log Pow value =2.3, high molecular weight) a dermal absorption rate of 50 % through skin was deduced.
Correction for difference between human and experimental exposure conditions: 7 d rat/5 d worker
Corrected NOAEL (dermal) for workers:
= 200 mg/kg bw/day x 2 x 1.4
= 560 mg/kg bw/day
Step 3: Use of assessment factors: 300
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (worker): 5
Exposure duration AF (subacute exposure period): 6
In conclusion the long term systemic dermal DNEL workers were calculated to be 1.87 mg/kg bw/day.
Acute short term dermal DNEL, worker
The test material is not classified and labelled for acute dermal toxicity, according to Regulation (EC) No 1272/2008 (CLP). Thus, in accordance with “Guidance on information requirements and chemical safety assessment, chapter R.8: Characterisation of dose (concentration)- response for human health” no DNEL is required.
Worker – Hazard for the eyes
According to the EU (CLP and GHS) criteria for classification and labelling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
References
(not included as endpoint study record)
- ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2.1. November 2012.
- ECHA (2017). Guidance on information requirements and chemical safety assessment.Chapter R.7c: Endpoint specific guidance: Guidance on Toxicokinetics. Version 3.0, June 2017
- ECHA (2012) Practical Guide 15: How to undertake a qualitative human health assessment and document it in a chemical safety report, November 2012.
- ECHA (2016). Guidance on information requirements and chemical safety assessment. Part E: Risk Characterisation, Version 3.0, May 2016
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.58 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by inhalation. A conservative approach is used by performing a route-to-route extrapolation. Please refer to the discussion.
- 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:
- An extrapolation factor is needed since a subacute study is available.
- 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:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the relatively homogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 1.74 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
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:
- 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure. Taken into account the physico-chemical properties of the substance, dermal absoption is anticipated to be 50 % of oral absorption. For details refer to the discussion.
- 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:
- An extrapolation factor is needed since a subacute study is available.
- 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:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the relatively homogenous group "general population" is used.
- 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:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 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:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation is required.
- 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:
- An extrapolation factor is needed since a subacute study is available.
- 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:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the relatively homogenous group "general population" is used.
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.99 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
General
DNEL derivation for the test substance is performed under consideration of the recommendations of ECHA. 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.
General population – Hazard via inhalation route
Long term systemic inhalation DNEL, general population
Calculation of dose descriptor
Step 1: Selection of the relevant dose descriptor (starting point):
For risk characterisation an inhalation NOAEC was derived by route-to-route extrapolation.
The oral NOAEL of 200 mg/kg bw/day, obtained from subacute repeated dose toxicity testing in rats was considered as key value for the chemical safety assessment and therefore, most relevant starting point.
Step 2: Modification into a correct starting point:
Standard respiratory volume of the rat (sRVrat) for 24 hours: 1.15 m3/kg bw
Oral absorption of the rat/ inhalation absorption of humans (ABS oral-rat / ABS inh-human): 50 %/100 % (default)
Corrected NOAEC (inhalation) for general population:
= 200 mg/kg bw/day x 0.5 x 1/1.15 m3/kg bw/day
= 87 mg/m3
Step 3: Use of assessment factors: 150
Interspecies: Respiratory interspecies differences are fully covered by the modification of the NOAEC
Interspecies AF, remaining differences: 2.5
Intraspecies AF (general population): 10
Exposure duration AF: 6 (chronic study)
In conclusion, long term systemic inhalation DNEL, general population = 0.58 mg/m³.
Short term acute inhalation DNEL, general population
No study for acute inhalation toxicity is availabe. As the substance is classified as acute toxic (oral) Cat 4 a acute inhalation toxicity can not be excluded and a cute inhalation DNEL is derived. The acute inhalation DNEL was based on long-term inhalation DNEL. The acute inhalation DNEL was calculated as 3 times the value of the corresponding long-term DNEL (ECHA CSR R.8, 2012). Thus, general population DNEL acute inhalation = 3 x 0.58 mg/m³/day = 1.74 mg/m³.
Local effects
No data on respiratory irritation is available. As the substance is not classified as skin and eye irritating also no adverse effects on respiratory system is expected (in accordance with "Guidance on information requirements and chemical safety assessment, chapter R.8"). Based on the physical parameters a peak exposure is not expected. The substance is solid with a very low vapour pressure. Inhalation exposure is regarded negligible as no particles below 125 µm were detected in particle size analysis (see section 4.5). Thus, no DNEL is required.
General population – Hazard via dermal route
Long term systemic dermal DNEL, general population
Calculation of dose descriptor
Step 1: Selection of the relevant dose descriptor (starting point):
For risk characterisation a dermal NOAEL was derived by route to route extrapolation.
The oral NOAEL of 200 mg/kg bw/day, obtained from subacute repeated dose oral toxicity testing in rats was considered as key value for the chemical safety assessment and therefore, most relevant starting point.
Step 2: Modification into a correct starting point:
Based on the physical chemical properties of the substance (low to moderate water solubility, log Pow value = 2.3) a dermal absorption rate of 50 % through skin was deduced.
In conclusion, dermal NOAEL = oral NOAEL x [ABS oral rat/ABS dermal human] = 200 mg/kg bw/day x (100/50) = 400 mg/kg bw/day.
Step 3: Use of assessment factors: 600
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (general population): 10
Exposure duration AF: 6 (subchronic to chronic)
In conclusion, long term systemic dermal DNEL, general population = 0.66 mg/kg bw/day
Acute short term dermal DNEL, general population
The test material is not classified and labelled for acute dermal toxicity, according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776. Thus, in accordance with “Guidance on information requirements and chemical safety assessment, chapter R.8: Characterisation of dose (concentration)- response for human health” no DNEL is required.
General population – Hazard via oral route
Long term systemic oral DNEL, general population
Step 1: Selection of the relevant dose descriptor (starting point):
A subacute oral study in rats is selected for DNEL derivation as it is the relevant repeated dose study performed. In this study, the oral NOAEL in rats is 200 mg/kg bw/day.
Step 2: Modification of the starting point:
Not required.
Step 3: Use of assessment factors: 600
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (general population): 10
Exposure duration AF: 6 (subchronic to chronic)
In conclusion, long term systemic oral DNEL, general population = 0.33 mg/kg bw/day
Acute short term oral DNEL, general population
As the substance is classified as acute toxic (oral) Cat 4 acute oral toxicity can not be excluded and acute oral DNEL is derived. The acute oral DNEL was based on long-term oral DNEL. The acute oral DNEL was calculated as 3 times the value of the corresponding long-term DNEL (ECHA CSR R.8, 2012). Thus, worker DNEL acute oral = 3 x 0.33 mg/m³/day =0.99 mg/m³.
General population – Hazard for the eyes
According to the EU (CLP and GHS) criteria for classification and labelling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
References
(not included as endpoint study record)
- ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2.1. November 2012.
- ECHA (2017). Guidance on information requirements and chemical safety assessment.Chapter R.7c: Endpoint specific guidance: Guidance on Toxicokinetics. Version 3.0, June 2017
- ECHA (2012) Practical Guide 15: How to undertake a qualitative human health assessment and document it in a chemical safety report, November 2012.
-ECHA (2016). Guidance on information requirements and chemical safety assessment. Part E: Risk Characterisation, Version 3.0, May 2016
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.