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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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.
Diss Factsheets
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EC number: 601-601-6 | CAS number: 119345-04-9
- 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:
- 64 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):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 320 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Factor of 2 was utilized for oral-to-inhalation route extrapolation for DOWFAX 2A1.
- AF for dose response relationship:
- 1
- Justification:
- Clear dose response with minimal toxicological findings up to the highest dose
- AF for differences in duration of exposure:
- 1
- Justification:
- Based on chronic exposure from 2-year study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA guidance, route-to-route extrapolation addresses allometic scaling
- AF for other interspecies differences:
- 1
- Justification:
- Substance tested in a number of species without significant adverse effects
- AF for intraspecies differences:
- 5
- Justification:
- Based on ECHA Guidance for workers
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- No additional uncertainties 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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 18.2 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):
- 7
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 128 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal absorption was assumed to be comparable to oral absorption. No route-to-route adjustment was performed for DOWFAX 2A1.
- AF for dose response relationship:
- 1
- Justification:
- Clear dose response with minimal toxicological findings up to the highest dose
- AF for differences in duration of exposure:
- 1
- Justification:
- Based on chronic exposure from 2-year study
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- Based on allometric scaling from dog to human (ECHA guidance)
- AF for other interspecies differences:
- 1
- Justification:
- Substance tested in a number of species without significant adverse effects
- AF for intraspecies differences:
- 5
- Justification:
- Based on ECHA Guidance for workers
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- No additional uncertainties 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
This substance is not classified as acutely toxic; therefore, acute/short term systemic dermal DNELs were not calculated.
Chronic, Systemic, Worker Inhalation DNEL
The starting point for the long-term, systemic inhalation DNEL is the chronic oral NOAEL of 128 mg/kg bw/day from the 2-year dog study. Conservative adjustment factor of 2 was applied to the starting NOAEL (64 mg/kg bw/day) to derive the starting inhalation NOAEC (i.e. ~50% oral absorption was assumed compared to 100% for inhalation absorption for DOWFAX 2A1). Based on the conversion, the starting 8hr worker NOAEC was 320 mg/m3. DNEL may be revised once the results from EOGRTS (OECD 443) study will become available.
Route-to-route extrapolation - 2 (Factor of 2 was utilized for oral (50% absorption assumed) to inhalation (100% absorption assumed) route extrapolation for DOWFAX 2A1).
The assessment factors for extrapolating to a DNEL are as follows:
Assessment factor for dose-response relationship- 1: clear dose response with minimal toxicological findings up to the highest dose
Allometric scaling - 1 (route-to-route extrapolation addresses allometic scaling)
'Other differences' - 1: as the registered substance (& its ADPODS category members) was tested in a number of species without significant adverse effects, the 2.5 assessment factors is not necessary.
Worker population variability - 5 (ECHA default)
Time extrapolation - 1 (Based on chronic exposure from 2-year study)
Quality of the database - 1 (ECHA default: the data are consistent and sufficient to conclude on a safe human level of exposure)
Total assessment factor: 5
Application of AF leads to inhalation systemic DNEL (worker) of 64 mg/m3.
Chronic, Systemic, Worker Dermal DNEL
The starting point for the long-term, systemic Dermal DNEL is the chronic oral NOAEL of 128 mg/kg bw/day from the 2-year dog study. DNEL may be revised once the results from EOGRTS (OECD 443) study will become available. As the dermal absorption for DOWFAX 2A1 was assumed to be comparable to oral absorption based on modelling of human bioavailability between the two routes, no adjustment was used to derive the starting dermal systemic NOAEL.
Route-to-route extrapolation - 1
The assessment factors for extrapolating to a DNEL are as follows:
Assessment factor for dose-response relationship- 1: clear dose response with minimal toxicological findings up to the highest dose
Allometric scaling - 1.4 (dog to man)
'Other differences' - 1: as the registered substance (& its ADPODS category members) was tested in a number of species without significant adverse effects, the 2.5 assessment factors is not necessary.
Worker population variability - 5 (ECHA default)
Time extrapolation - 1 (Based on chronic exposure from 2-year study)
Quality of the database - 1 (ECHA default: the data are consistent and sufficient to conclude on a safe human level of exposure)
Total assessment factor: 7
Application of AF leads to dermal systemic DNEL (worker) of 18.2 mg/kg/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 160 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Factor of 2 was utilized for oral-to-inhalation route extrapolation for DOWFAX 2A1.
- AF for dose response relationship:
- 1
- Justification:
- clear dose response with minimal toxicological findings up to the highest dose
- AF for differences in duration of exposure:
- 1
- Justification:
- Based on chronic exposure from 2-year study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA guidance, route-to-route extrapolation addresses allometic scaling
- AF for other interspecies differences:
- 1
- Justification:
- Substance tested in a number of species without significant adverse effects
- AF for intraspecies differences:
- 10
- Justification:
- Based on ECHA Guidance for general population
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- No additional uncertainties 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:
- 9.14 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):
- 14
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 128 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal absorption was assumed to be comparable to oral absorption. No adjustment was performed.
- AF for dose response relationship:
- 1
- Justification:
- Clear dose response with minimal toxicological findings up to the highest dose
- AF for differences in duration of exposure:
- 1
- Justification:
- Based on chronic exposure from 2-year study
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- Based on allometric scaling from dog to human (ECHA guidance)
- AF for other interspecies differences:
- 1
- Justification:
- Substance tested in a number of species without significant adverse effects
- AF for intraspecies differences:
- 10
- Justification:
- Based on ECHA Guidance for General Population
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- No additional uncertainties 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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.14 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):
- 14
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 128 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- 1 for oral-to-oral route extrapolation (based on ECHA guidance).
- AF for dose response relationship:
- 1
- Justification:
- Clear dose response with minimal toxicological findings up to the highest dose
- AF for differences in duration of exposure:
- 1
- Justification:
- Based on chronic exposure from 2-year study
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- Based on allometric scaling from dog to human (ECHA guidance)
- AF for other interspecies differences:
- 1
- Justification:
- Substance tested in a number of species without significant adverse effects
- AF for intraspecies differences:
- 10
- Justification:
- Based on ECHA Guidance for General Population
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- No additional uncertainties 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:
- medium hazard (no threshold derived)
Additional information - General Population
This substance is not classified as acutely toxic; therefore, acute/short term systemic DNELs were not calculated.
Chronic, Systemic, General Population Inhalation DNEL
The starting point for the long-term, systemic inhalation DNEL is the chronic oral NOAEL of 128 mg/kg bw/day from the 2-year dog study. Conservative adjustment factor of 2 was applied to the starting NOAEL (64 mg/kg bw/day) to derive the starting inhalation NOAEC (i.e. ~50% oral absorption was assumed compared to 100% for inhalation absorption for DOWFAX 2A1). Based on the conversion, the starting 24hr general public NOAEC was 160 mg/m3. DNEL may be revised once the results from EOGRTS (OECD 443) study will become available.
Route-to-route extrapolation - 2 (Factor of 2 was utilized for oral (50% absorption assumed) to inhalation (100% absorption assumed) route extrapolation for DOWFAX 2A1).
The assessment factors for extrapolating to a DNEL are as follows:
Assessment factor for dose-response relationship- 1: clear dose response with minimal toxicological findings up to the highest dose
Allometric scaling - 1 (route-to-route extrapolation addresses allometic scaling)
'Other differences' - 1: as the registered substance (& its ADPODS category members) was tested in a number of species without significant adverse effects, the 2.5 assessment factors is not necessary.
General population variability - 10 (ECHA default)
Time extrapolation - 1 (Based on chronic exposure from 2-year study)
Quality of the database - 1 (ECHA default: the data are consistent and sufficient to conclude on a safe human level of exposure)
Total assessment factor: 10
Application of AF leads to inhalation systemic DNEL (general population) of 16 mg/m3.
Chronic, Systemic, General Population Dermal DNEL
The starting point for the long-term, systemic Dermal DNEL is the chronic oral NOAEL of 128 mg/kg bw/day from the 2-year dog study. DNEL may be revised once the results from EOGRTS (OECD 443) study will become available. As the dermal absorption for DOWFAX 2A1 was assumed to be comparable to oral absorption based on modelling of human bioavailability between the two routes, no adjustment was used to derive the starting dermal systemic NOAEL.
Route-to-route extrapolation - 1
The assessment factors for extrapolating to a DNEL are as follows:
Assessment factor for dose-response relationship- 1: clear dose response with minimal toxicological findings up to the highest dose
Allometric scaling - 1.4 (dog to man)
'Other differences' - 1: as the registered substance (& its ADPODS category members) was tested in a number of species without significant adverse effects, the 2.5 assessment factors is not necessary.
General population variability - 10 (ECHA default)
Time extrapolation - 1 (Based on chronic exposure from 2-year study)
Quality of the database - 1 (ECHA default: the data are consistent and sufficient to conclude on a safe human level of exposure)
Total assessment factor: 14
Application of AF leads to dermal systemic DNEL (general population) of 9.14 mg/kg/day.
Chronic, Systemic, General Population Oral DNEL
Even though there are no consumer uses that require derivation of the oral DNEL value, one has been derived and provided for completeness, but not used in the risk characterization calculations.
The starting point for the long-term, systemic oral DNEL is the 2-year dog oral study NOAEL of 128 mg/kg bw/day.
DNEL may be revised once the results from EOGRTS (OECD 443) study will become available.
The assessment factors for extrapolating to a DNEL are as follows:
Allometric scaling - 1.4 (dog to man)
'Other differences' - 1: as the registered substance (& its ADPODS category members) was tested in a number of species without significant adverse effects, the 2.5 assessment factors is not necessary.
General population variability - 10 (based on ECHA guidance)
Time extrapolation - 1 (Based on chronic exposure from 2-year study)
Quality of the database - 1 (ECHA default)
Total assessment factor: 14
Application of AF leads to an oral DNEL (general population) of 9.14 mg/kg/day.
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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