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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 452-570-9 | CAS number: -
- 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:
- 0.248 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):
- 75
- Dose descriptor starting point:
- NOAEC
- Value:
- 37 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 18.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For the given human exposure route there is a dose descriptor for the same route in experimental animals but there are differences in respiratory volumes between experimental animals (at rest) and humans (light activity).
- 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:
- 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
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose 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:
- 2.8 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 840 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure. A conservative approach is used assuming a four times higher absorption via the oral route (starting route) as compared to the dermal route (end route).
- 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:
- 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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- medium hazard (no threshold derived)
Additional information - workers
General
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA (2010).
Acute, systemic, DNEL
The test item is not classified and labelled for acute systemic toxicity, according to Regulation (EC) No 1272/2008 (CLP), based on the test data for acute oral, dermal and inhalation toxicity.
Acute/short term DNEL for local effects
The inhalation DNEL for short term local effects does not need to be derived as this DNEL is covered by the derived inhalation DNEL for long term local effects. Furthermore, the test item is not classified and labelled for acute inhalation toxicity, according to Regulation (EC) No 1272/2008 (CLP).
Skin irritation: The test item is classified for skin irritation cat. 2, according to Regulation (EC) No 1272/2008 (CLP) and thus associated to the low hazard band.
Sensitization: However, the test item is not classified and labelled as skin sensitizer according to Regulation (EC) No 1272/2008 (CLP).
Eye irritation:The test item is classified for eye irritation cat.1 according to Regulation (EC) No 1272/2008 (CLP) and thus associated to the medium hazard band.
Long term, DNEL for local effects
Since no threshold value could be derived in the repeated dose toxicity study, a qualitative risk assessment was carried out. The test item is classified for STOT SE cat. 3 according to Regulation (EC) No 1272/2008 (CLP) and is therefore attributable to the low hazard band. Since the substance concentration in preparation is lower than 10% for industrial and professional use, local effects are not considered as no classification is required for this diluted mixtures (Regulation (EC) No 1272/2008 (CLP)).
Long term, systemic DNEL
Occupational exposure to the test item occurs by inhalation exposure. Two long-term DNELs are calculated for workers. Unless otherwise indicated, the "quality of whole database factor", “remaining uncertainties” and "dose-response factor" are considered to amount each to a value of 1.
Exposure by inhalation
Step 1: Selection of the relevant dose descriptor (starting point):
The sub-acute (four-week) inhalation toxicity study is selected for DNEL derivation as it is the relevant repeated dose study which is equivalent to the OECD guideline 412. In this study, the NOAEC (systemic) in rats is 37 mg/m3, the highest dose tested.
Step 2: Modification into a correct starting point
Using a conservative approach, a worker DNEL (long-term inhalation exposure) is derived. This worker DNEL is considered to ensure an appropriate level of protection with regard to acute inhalation exposure (no high peaks of exposure expected).
Relevant dose descriptor (NOAEC): 37 mg/m3
Duration of exposure used in study: 6 h (5 days per week)
Duration of exposure of the worker: 8 h (5 days per week)
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:
= 37 mg/m3x 6 h/8 h x 6.7 m3/10 m3= 18.6 mg/m3
Step 3: Use of assessment factors: 75
AF for differences in duration of exposure: 6
AF for other interspecies differences: 2.5
AF for intraspecies differences: 5
In conclusion, long term systemic inhalation DNEL, workers = 0.248 mg/m3.
Dermal exposure
Step 1: Selection of the relevant dose descriptor (starting point):
There are no relevant experimental data on repeated dermal exposure. Thus, the OECD TG 407 study (2008), performed with the main compound is selected for DNEL derivation as it is the relevant repeated dose study performed in accordance to OECD guideline and GLP. In this study, the NOAEL (systemic) in rats is 100 mg/kg bw/day.
Step 2: Modification of the starting point:
Using a conservative approach, a worker DNEL (long-term dermal exposure) is derived. The oral NOAEL rat is converted into a dermal NOAEL rat. Based on the physico-chemical properties of Troysol LAC (log Kow: 8.2 and water solubility: 0.2 mg/L) a 4 times higher absorption via the oral route (starting route) as compared to the dermal route (end route) is assumed as a worst case.
Relevant dose descriptor (NOAEL): 100 mg/kg bw/day
Absorption (oral, animal): 100%
Absorption (dermal, human): 25%
Dermal NOAEL for workers:
= 100 mg/kg bw/d x 100% / 25% = 400 mg/kg bw/d based on the main compound (98.3%).
For the mixture (46.5% main compound), the dermal NOAEL for workers is 840 mg/kg bw/d.
Step 3: Use of assessment factors: 300
AF for differences in duration of exposure: 6
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (worker): 5
In conclusion, long term systemic dermal DNEL (workers) for the mixture = 2.8 mg/kg bw/day.
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. ECHA-2010-G-19-EN.
- ECHA (2014). Guidance on information requirements and chemical safety assessment.Chapter R.7.12: Endpoint specific guidance: Guidance on Toxicokinetics. ECHA-14-G-06-N.
- ECHA (2012) Practical Guide 15: How to undertake a qualitative human health assessment and document it in a chemical safety report, November 2012.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.044 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):
- 150
- Dose descriptor starting point:
- NOAEC
- Value:
- 37 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 6.61 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For the given human exposure route there is a dose descriptor for the same route in experimental animals but there are differences in the exposure duration between experimental animals and humans.
- 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:
- 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
- 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:
- 1.4 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 840 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure. A conservative approach is used assuming a four times higher absorption via the oral route (starting route) as compared to the dermal route (end route).
- 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:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous 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:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 0.35 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 210 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:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous 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
- 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 (2010).
Acute, systemic, DNEL
The test item is not classified and labelled for acute systemic toxicity, according to Regulation (EC) No 1272/2008 (CLP), based on the test data for acute oral, dermal and inhalation toxicity.
Acute/short term DNEL for local effects
The DNEL for local effects is not considered to be derived for consumers as the substance concentration in preparation is only 0.7% which does not lead to classification according to Regulation (EC) No 1272/2008 (CLP).
Long term DNEL (local)
The DNEL for local effects is not considered to be derived for consumers as the substance concentration in preparation is only 0.7% which does not lead to classification according to Regulation (EC) No 1272/2008 (CLP).
Long term DNEL(systemic)
Occupational exposure to the test item occurs by inhalation exposure. Altogether four long-term DNELs are calculated for general population. Unless otherwise indicated, the "quality of whole database factor", “remaining uncertainties” and "dose-response factor" are considered to amount each to a value of 1.
Exposure by inhalation
Step 1: Selection of the relevant dose descriptor (starting point):
The sub-acute (four-week) inhalation toxicity study is selected for DNEL derivation as it is the relevant repeated dose study which is equivalent to the OECD guideline 412. In this study, the NOAEC in rats is 37 mg/m3, the highest dose tested.
Step 2: Modification into a correct starting point
Using a conservative approach, a DNEL for general population (long-term inhalation exposure) is derived. This DNEL is considered to ensure an appropriate level of protection with regard to acute inhalation exposure (no high peaks of exposure expected).
Relevant dose descriptor (NOAEC): 37 mg/m3
Duration of exposure used in study: 6 h (5 days per week)
Duration of exposure of the general population: 24 h (5 days per week)
Corrected inhalatory NOAEC for general population:
= 37 mg/m3x 6 h/24 h x 5 d/7 d = 6.61 mg/m3
Step 3: Use of assessment factors: 150
AF for differences in duration of exposure: 6
AF for other interspecies differences: 2.5
AF for intraspecies differences: 10
In conclusion, long term systemic inhalation DNEL, general population = 0.044 mg/m3.
Dermal exposure
Step 1: Selection of the relevant dose descriptor (starting point):
There are no relevant experimental data on repeated dermal exposure. Thus, the OECD TG 407 study (2008), performed with the main compound is selected for DNEL derivation as it is the relevant repeated dose study performed in accordance to OECD guideline and GLP. In this study, the NOAEL (systemic) in rats is 100 mg/kg bw/d.
Step 2: Modification of the starting point:
Using a conservative approach, a DNEL general population (long-term dermal exposure) is derived. The oral NOAEL rat is converted into a dermal NOAEL rat. Based on the physico-chemical properties of Troysol LAC (log Kow: 8.2 and water solubility: 0.2 mg/L) a four times higher absorption via the oral route (starting route) as compared to the dermal route (end route) is assumed as a worst case.
Relevant dose descriptor (NOAEL): 100 mg/kg bw/day
Absorption (oral, animal) = 100%
Absorption (dermal, human) = 25%
Dermal NOAEL for general population:
= 100 mg/kg bw/d x 100 %/ 25% = 400 mg/kg bw/dbased on the main compound (98.3%)
For the mixture (46.5% main compound), the dermal NOAEL for general population is 840 mg/kg bw/d.
Step 3: Use of assessment factors: 600
AF for differences in duration of exposure: 6
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (worker): 10
In conclusion, long term systemic dermal DNEL (general population) for the mixture = 1.4 mg/kg bw/day.
Oral exposure (systemic)
Step 1: Selection of the relevant dose descriptor (starting point):
No route to route extrapolation is necessary since a GLP and guideline conform repeated dose oral toxicity study is available (OECD TG 407). In this study, the NOAEL (systemic) in rats is 100 mg/kg bw/d.
Step 2: Modification of the starting point:
No modification is necessary.
Relevant dose descriptor (NOAEL): 100 mg/kg bw/d
Oral NOAEL for general population:
= 100 mg/kg bw/dbased on the main compound (98.3%)
For the mixture (46.5% main compound), the oral NOAEL for general population is 210 mg/kg bw/d.
Step 3: Use of assessment factors: 600
AF for differences in duration of exposure: 6
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (worker): 10
In conclusion, long term systemic oral DNEL (general population) for the mixture = 0.35 mg/kg bw/day.
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. ECHA-2010-G-19-EN.
- ECHA (2014). Guidance on information requirements and chemical safety assessment.Chapter R.7.12: Endpoint specific guidance: Guidance on Toxicokinetics. ECHA-14-G-06-N.
- ECHA (2012) Practical Guide 15: How to undertake a qualitative human health assessment and document it in a chemical safety report, November 2012.
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.