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EC number: 456-830-2 | CAS number: 745070-61-5
- 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:
- 70.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Worker:
Based on the available data, Propanamide, N, N', N''-1,3,5-benzenetriyltris[2,2-dimethyl-(9Cl)] does not need to be classified and labelled concerning human health hazards according to the Dangerous Substance Directive (67/548/EEC) and the Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008 (CLP).
The primary routes of anticipated industrial exposure to the substance are via inhalation and skin contact. In industrial settings, ingestion is not an anticipated route of exposure, but has to be considered for the general population (see below).
Dermal long-term exposure – systemic effects:
The NOAEL from an oral repeated dose study with rats conducted according to OECD TG 408 (BASF SE 2012) was identified as the appropriate starting point for DNEL derivation for long-term exposure following dermal contact. The oral administration of the test substance via the diet over a period of 3 months revealed no signs of toxicity up to a concentration of 15000 ppm in male (961 mg/kg bw/d) and female Wistar rats (1104 mg/kg bw/d).
Thus, the NOAEL for general, systemic toxicity of the test substance was 1000 mg/kg bw/d for male and female rats equivalent to the highest dose tested.
As recommended by REACh TGD (R.8, 2010), dermal absorption is not assumed to be higher than oral absorption. Therefore, no additional default factor (factor 1) was introduced.
For DNEL derivation, the following assessment factors (AF) were applied to the starting point:
- Interspecies factor: 4
For allometric scaling a factor of 4 for differences in metabolic rate and toxicokinetics was used as recommended by Reach TGD.
- Remaining differences: 2.5
As recommended by Reach TGD an additional interspecies factor of 2.5 for remaining differences has been used.
- Intraspecies factor: 5
Based on REACh TGD, an intraspecies assessment factor of 5 (worker) was adopted here.
- Exposure duration: 2
An assessment factor of 2 was chosen for extrapolation of a subchronic study to chronic exposure, according to Reach TGD.
- Dose-response: 1 (default)
- Uncertainty factor: 1 (default)
Total AF = 2.5 x 4 x 5 x 2 = 100.
Based on this calculation the resulting DNEL is 10 mg/kg bw/d.
This value is considered protective for systemic effects by the dermal route.
Inhalation long-term exposure –systemic effects:
The NOAEL from an oral repeated dose study with rats conducted according to OECD TG 408 (BASF SE 2012) was identified as the appropriate starting point for DNEL derivation for long-term exposure following inhalation. The oral administration of the test substance via the diet over a period of 3 months revealed no signs of toxicity up to a concentration of 15000 ppm in male (961 mg/kg bw/d) and female Wistar rats (1104 mg/kg bw/d).
Thus, the NOAEL for general, systemic toxicity of the test substance was 1000 mg/kg bw/d for male and female rats equivalent to the highest dose tested.
This point of departure was modified to get the corrected starting point for DNEL derivation. As a first step, route-to-route extrapolation was performed as recommended in the "Guidance on information requirements and chemical safety assessment, Chapter R.8, p. 58 f.:
The oral rat NOAEL was converted into the inhalative human NAEC corrected for differences between the 8-hour standard inhalation volume of rats versus humans, and for differences between the 8-hour inhalation volume of workers in rest versus workers in light activity, by multiplying with the corresponding factors (x 1/0.38 m³/kg/d x 6.7 m³/10 m³).
For differences between oral absorption in rats and inhalative absorption in humans no additional assessment factor (factor 1) was used, since no considerable bioavailability of the substance by inhalation is expected based on the physical-chemical data and the complete lack of toxicity by the oral and dermal route.
The resulting corrected starting point for inhalation DNEL derivation for workers is equal to 1763 mg/m³.
For DNEL derivation, the following assessment factors (AF) were applied to the corrected starting point:
- Interspecies factor: 2.5
Besides the applied allometric scaling factors (see modification of point of departure) an additional interspecies factor of 2.5 for remaining differences has been used.
- Intraspecies factor: 5
Based on REACh TGD, an intraspecies assessment factor of 5 (worker) was adopted here.
- Exposure duration: 2
An assessment factor of 2 was chosen for extrapolation of a subchronic study to chronic exposure, according to Reach TGD.
- Dose-response: 1 (default)
- Uncertainty factor: 1 (default)
Total AF = 2.5 x 5 x 2 = 25
Based on this calculation the resulting DNEL is 70.5 mg/m³.
This value is considered protective for systemic effects by the inhalation route.
· ECHA (2010). REACh Guidance document R.8
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
General population:
Based on the available data, Propanamide, N, N', N''-1,3,5-benzenetriyltris[2,2-dimethyl-(9Cl)] does not need to be classified and labelled concerning human health hazards according to the Dangerous Substance Directive (67/548/EEC) and the Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008 (CLP).
For the general population, all three possible routes of exposure (oral, dermal, inhalation) have to be taken into account.
Dermal long-term exposure – systemic effects:
The NOAEL from an oral repeated dose study with rats conducted according to OECD TG 408 (BASF SE 2012) was identified as the appropriate starting point for DNEL derivation for long-term exposure following dermal contact. The oral administration of the test substance via the diet over a period of 3 months revealed no signs of toxicity up to a concentration of 15000 ppm in male (961 mg/kg bw/d) and female Wistar rats (1104 mg/kg bw/d).
Thus, the NOAEL for general, systemic toxicity of the test substance was 1000 mg/kg bw/d for male and female rats equivalent to the highest dose tested.
As recommended by REACh TGD (R.8, 2010), dermal absorption is not assumed to be higher than oral absorption. Therefore, no additional default factor (factor 1) was introduced.
For DNEL derivation, the following assessment factors (AF) were applied to the starting point:
- Interspecies factor: 4
For allometric scaling a factor of 4 for differences in metabolic rate and toxicokinetics was used as recommended by Reach TGD.
- Remaining differences: 2.5
As recommended by Reach TGD an additional interspecies factor of 2.5 for remaining differences has been used.
- Intraspecies factor: 10
Based on REACh TGD, an intraspecies assessment factor of 10 (general population) was adopted here.
- Exposure duration: 2
An assessment factor of 2 was chosen for extrapolation of a subchronic study to chronic exposure, according to Reach TGD.
- Dose-response: 1 (default)
- Uncertainty factor: 1 (default)
Total AF = 2.5 x 4 x 10 x 2 = 200.
Based on this calculation the resulting DNEL is 5 mg/kg bw/d.
This value is considered protective for systemic effects by the dermal route.
Inhalation long-term exposure –systemic effects:
The NOAEL from an oral repeated dose study with rats conducted according to OECD TG 408 (BASF SE 2012) was identified as the appropriate starting point for DNEL derivation for long-term exposure following inhalation. The oral administration of the test substance via the diet over a period of 3 months revealed no signs of toxicity up to a concentration of 15000 ppm in male (961 mg/kg bw/d) and female Wistar rats (1104 mg/kg bw/d).
Thus, the NOAEL for general, systemic toxicity of the test substance was 1000 mg/kg bw/d for male and female rats equivalent to the highest dose tested.
This point of departure was modified to get the corrected starting point for DNEL derivation. As a first step, route-to-route extrapolation was performed as recommended in the "Guidance on information requirements and chemical safety assessment, Chapter R.8, p. 58 f.:
The oral rat NOAEL was converted into the inhalative human NAEC corrected for differences between the 8-hour standard inhalation volume of rats versus humans by multiplying with the corresponding factor (x 1/1.15 m³/kg/d).
For differences between oral absorption in rats and inhalative absorption in humans no additional assessment factor (factor 1) was used, since no considerable bioavailability of the substance by inhalation was expected based on the physical-chemical data and the complete lack of toxicity by the oral and dermal route.
The resulting corrected starting point for inhalation DNEL derivation for the general population is equal to 870 mg/m³.
For DNEL derivation, the following assessment factors (AF) were applied to the corrected starting point:
- Interspecies factor: 2.5
Besides the applied allometric scaling factors (see modification of point of departure) an additional interspecies factor of 2.5 for remaining differences has been used.
- Intraspecies factor: 10
Based on REACh TGD, an intraspecies assessment factor of 10 (general population) was adopted here.
- Exposure duration: 2
An assessment factor of 2 was chosen for extrapolation of a subchronic study to chronic exposure, according to Reach TGD.
- Dose-response: 1 (default)
- Uncertainty factor: 1 (default)
Total AF = 2.5 x 10 x 2 = 50
Based on this calculation the resulting DNEL is 17.4 mg/m³.
This value is considered protective for systemic effects by the inhalation route.
Oral long-term exposure – local and systemic effects:
In addition, the DNEL for oral long-term exposure was derived from the no observed adverse effect level obtained in a diet study conducted with the substance in rats according to OECD TG 408 (BASF SE, 2012).
The oral administration of the test substance via the diet over a period of 3 months revealed no signs of toxicity up to a concentration of 15000 ppm in male (961 mg/kg bw/d) and female Wistar rats (1104 mg/kg bw/d).
Thus, the NOAEL for general, systemic toxicity of the test substance was 1000 mg/kg bw/d for male and female rats equivalent to the highest dose tested.
Subsequently, the following assessment factors (AF) were taken into account for the final DNEL calculation for the oral route:
- Interspecies factor: 4
For allometric scaling a factor of 4 for differences in metabolic rate and toxicokinetics was used as recommended by Reach TGD.
- Remaining differences: 2.5
As recommended by Reach TGD an additional interspecies factor of 2.5 for remaining differences has been used.
- Intraspecies factor: 10
Based on REACh TGD, an intraspecies assessment factor of 10 (general population) was adopted here.
- Exposure duration: 2
An assessment factor of 2 was chosen for extrapolation of a subchronic study to chronic exposure, according to Reach TGD.
- Dose-response: 1 (default)
- Uncertainty factor: 1 (default)
Total AF = 2.5 x 4 x 10 x 2 = 200.
Based on this calculation the resulting DNEL is 5 mg/kg bw/d.
This value is considered protective for systemic effects by the oral route.
· ECHA (2010). REACh Guidance document R.8
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