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EC number: 219-460-0 | CAS number: 2439-35-2
- 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:
- 0.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.5 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.5 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
The acute as well as the repeated inhalation toxicity is based on the corrosive properties of the substance.
The acute inhalation DNEL for local effects is therefore based on the acute inhalation toxicity study showing a LC0 = 0.09 mg/l analytically measured (BASF 1979) . The dose-response curve in the acute inhalation toxicity studies is very steep, therefore an assessment factor of 50 seems to be appropriate, resulting in an acute inhalation DNEL of 4.5 mg/m3.
For workers the inhalative and dermal routes are the most likely for exposure. On account of the corrosive effect of ADAME and of the highly accepted use of suitable protective equipment it can be assumed that, as a rule, daily repeated immediate skin or eye contact is avoided to a large extent by using suitable personal protective equipment. Therefore, the DNELs derived for local and systemic effects from long-term exposure by inhalation are considered sufficient to ensure the safety of human workers.
Long-term exposure - local & systemic effects:
The NOAEL value from a subchronic oral repeated dose study with rats (Atochem, 1999) was identified to be the most appropriate starting point for DNEL derivation for long-term exposure following inhalation. The respective NOAEL for local and systemic effects was 10 mg/kg bw/day, based on histopathological findings in the forestomach due to direct irritation of the test substance. At the next dose level of 50 mg/kg bw/day lethality occured in 22 out of 40 animals due to direct irritant effects in the lungs of regurgitated stomach contents. Further findings were ptyalism, loud breathing, increase in neutrophil counts, and direct irritant effects in the forestomach (gross pathological findings with histopathological correlates).
The starting point was modified to get the correct 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. 26 f.:
The oral rat NOAEL was converted into the inhalative human NOAEC corrected for differences between the 8-hour standard inhalation volume of rats versus humans, for differences between oral absorption in rats and inhalative absorption in humans (50% and 100%, respectively), 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 50%/100% x 6.7 m³/10 m³). The resulting corrected starting point for inhalation DNEL derivation for workers is equal to 8.8 mg/m³.
For DNEL derivation, the following assessment factors (AF) were applied to the correct starting point:
- Interspecies factor: 1
Besides the applied allometric scaling factors no additional interspecies factor for remaining differences has been used based on the fact that concerning inhalation, rodents like the rat are in general more sensitive compared to human as the rat's ventilation frequency is higher. Also anatomical differences as well as air flow patterns between rodents and human have to be taken into account.
- Intraspecies factor: 2
Systemic effects in the repeated dose study with rats were minimal and restricted to an increase in neutrophil counts probably as a secondary effect following local irritation in the forestomach of rats. Furthermore, since the test substance is considered to be a local irritant without much specific systemic toxicity, not much variation of the irritant effect of the test substance in human workers is expected. Therefore an intraspecies factor of 2 is considered to be sufficient.
- Exposure duration: 2 (default)
From subchronic to chronic an assessment factor of 2 was taken by default.
- Dose-response: 1 (default)
- Uncertainty factor: 2.5 (default)
Total AF = 2 x 2 x 2.5 = 10
Based on this calculation the resulting DNEL is 0.9 mg/m³ ( 0.15 ppm)
.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.09 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
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.09 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Dose descriptor:
- NOAEC
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Consumer exposure to 2-(dimethylamino) ethyl acrylate is very unlikely. Only a DNEL for local and systemic effects from long-term exposure by inhalation are determined for the safety of the general population.
Long-term exposure - local & systemic effects:
The NOAEL value from a subchronic oral repeated dose study with rats (Atochem, 1999) was identified to be the most appropriate starting point for DNEL derivation for long-term exposure following inhalation. The respective NOAEL for local and systemic effects was 10 mg/kg bw/day, based on histopathological findings in the forestomach due to direct irritance of the test substance. At the next dose level of 50 mg/kg bw/day lethality occured in 22 out of 40 animals due to direct irritant effects in the lungs of regurgitated stomach contents. Further findings were ptyalism, loud breathing, increase in neutrophil counts, and direct irritant effects in the forestomach (gross pathological findings with histopathological correlates).
The starting point was modified to get the correct 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. 26 f.:
The oral rat NOAEL was converted into the inhalative human NOAEC corrected for differences between the 24-hour standard inhalation volume of rats versus humans and for differences between oral absorption in rats and inhalative abosrption in humans (50% and 100%, respectively), by multiplying with the corresponding factors (x 1/1.15 m³/kg/d x 50%/100%). The resulting corrected starting point for inhalation DNEL derivation for the general population is equal to 4.3 mg/m³.
For DNEL derivation, the following assessment factors (AF) were applied to the correct starting point:
- Interspecies factor: 1
Besides the applied allometric scaling factors no interspecies factor for remaining differences has been used based on the fact that concerning inhalation, rodents like the rat are in general more sensitive compared to human as the rat's ventilation frequency is higher. Also anatomical differences as well as air flow patterns between rodents and human have to be taken into account.
- Intraspecies factor: 10 (default)
The intraspecies variations were recognised by an assessment factor of 10 by default.
- Exposure duration: 2 (default)
From subchronic to chronic an assessment factor of 2 was taken by default.
- Dose-response: 1 (default)
- Uncertainty factor: 2.5 (default)
Total AF = 50
Based on this calculation the resulting DNEL is 0.09 mg/m³ ( 0.015 ppm).
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