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EC number: 442-490-2 | CAS number: 871-70-5 EMEROX 118
- 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:
- 17.632 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Most sensitive endpoint:
- skin irritation/corrosion
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):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Additional information - workers
In general, the calculation of a DNEL is based on the observed effect level which has to be modified as described in “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, May 2008).
Long-term dermal and inhalative intakes are the possible exposure routes for workers, whereas oral, dermal and inhalative intakes are the possible exposure routes for the general population. Together with the fact that no substance-related acute effects could be determined, only the DNEL for long-term systemic effects is derived.
Regarding acute and long-term local effects, local irritation on skin and/or mucous membranes as primary effect can be expected for fatty acids with a chain length ≤ C12and for C22:1 (erucic acid) due to the corrosive/irritation properties of the short- and mid-chain fatty acids C6 – C12 and C22:1, respectively.
Since no adequate dose descriptor for the corrosion/irritation effects could be derived, no DNEL is calculated for local effects. However, appropriate risk management measures will be identified.
As starting point for derivation of the DNEL, the NOAEL of 1000 mg/kg bw/day (for systemic effects) was used which was found in a study performed according to OECD 422 where the males were treated by gavage for 42 days with docosanoic acid and the females 14 days priorto mating until day 3 of lactation (Nagao et al., 2002).
A substance-specific adjustment of the NOAEL is not performed since the obtained value of 1000 mg/kg bw/day reflects the “worst case” among the available key studies for repeated dose toxicity and for toxicity on reproduction of fatty acids within the category.
Inhalation
For calculation of the DNEL for long-term inhalative systemic effects, the dose descriptor has to be converted into a corrected starting point by route-to-route extrapolation. The absorption difference for inhalation compared to the oral route is reflected by the factor 2 as suggested by the R.8. Besides this, the interspecies difference between rat and human has to be taken into account. Therefore, the no observed effect level has to be corrected by the risk assessor 6.7 / 0.38*10 regarding breathing volume and frequency. Thus, the corrected starting point for workers was 881.6 mg/m³/d for inhalation.
Subsequently assessment factors are listed, which have to be taken into account for the final DNEL calculation: remaining interspecies-differences (2.5), intraspecies differences (5), exposure duration (4). An assessment factor of (4) for duration extrapolation was choosen, since in the combined repeated dose and reproductive/developmental toxicity screening test (Nagao et al., 2002) from which the NOAEL was taken as starting point, the exposure duration exceeds a subacate exposure duration of 28 days. Thus the mean value (4) of the default assessment factor (6) for an extrapolation subacute - chronic and the default assessment factor (2) for an extrapolation subchronic – chronic was taken.
The DNEL is calculated according to the formula DNEL = (corrected starting point)/(overall AF). The DNEL is calculated according to the formula DNEL = (corrected starting point)/(overall AF): Thus, the resulting DNEL for long-term inhalative systemic effects is 17.632 mg/m³ for workers.
Dermal
For calculation of the DNEL for long-term dermal systemic effects, the dose descriptor has to be converted into a corrected starting point by route-to-route extrapolation. The absorption difference for the dermal route compared to the oral route is adjusted by the factor 0.5 due to the skin absorption classification as moderate based on the QSAR result for hexanoic acid (Danish EPA Database, 2004). This fatty acid has the highest absorption rate among all members of the category with 0.021 mg/cm² reflecting the worst case for all category members. Thus the corrected starting point for workers was 2000 mg/kg bw for the dermal route.
Subsequently, following assessment factors are taken into account for the final DNEL calculation: interspecies differences (4), remaining interspecies-differences (2.5), intraspecies differences (5), exposure duration (4).
As a consequence, the resulting DNEL for long-term dermal systemic effects is 10.0 mg/kg bw/day for workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.348 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 100
- 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):
- 400
- 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:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 400
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
In general, the calculation of a DNEL is based on the observed effect level which has to be modified as described in “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, May 2008).
Long-term dermal and inhalative intakes are the possible exposure routes for workers, whereas oral, dermal and inhalative intakes are the possible exposure routes for the general population. Together with the fact that no substance-related localeffects could be determined, only the DNEL for long-term systemic effects is derived.
As starting point for derivation of the DNEL, the NOAEL of 1000 mg/kg bw/day (for systemic effects) was used which was found in a study performed according to OECD 422 where the males were treated by gavage for 42 days with docosanoic acid and the females 14 days prior to mating until day 3 of lactation (Nagao et al., 2002 or e.g. OECD 407 repeaded dose toxicity oral 14 and 28 days of C18 di (871 -70 -5) with NOAEL 1000 mg/kg bw.
A substance-specific adjustment of the NOAEL is not performed since the obtained value of 1000 mg/kg bw/day reflects the “worst case” among the available key studies for repeated dose toxicity and for toxicity on reproduction of fatty acids within the category.
Inhalation
For calculation of the DNEL for long-term inhalative systemic effects, the dose descriptor has to be converted into a corrected starting point by route-to-route extrapolation. The absorption difference for inhalation compared to the oral route is reflected by the factor 2 as suggested by the R.8. Besides this, the interspecies difference between rat and human has to be taken into account. Therefore, the no observed effect level has to be corrected by the risk assessor 1/1.15 regarding breathing volume and frequency. Thus, the corrected starting point for the general population is 434.8 mg/m³/day for inhalation.
Subsequently assessment factors are listed, which have to be taken into account for the final DNEL calculation: remaining interspecies-differences (2.5), intraspecies differences (10), exposure duration (4). An assessment factor of (4) for duration extrapolation was choosen, since in the combined repeated dose and reproductive/developmental toxicity screening test (Nagao et al., 2002) from which the NOAEL was taken as starting point, the exposure duration exceeds a subacate exposure duration of 28 days. Thus a mean value of the default assessment factor (6) for an extrapolation subacute - chronic and the default assessment factor (2) for an extrapolation subchronic – chronic was taken.
The DNEL is calculated according to the formula DNEL = (corrected starting point)/(overall AF). Thus, the resulting DNEL for long-term inhalative systemic effects is 4.348 mg/m³ for the general population.
Oral
For the DNEL of systemic oral effects a correction of the starting point is not required, since the observed effect level was derived in oral repeated dose toxicity study (Nagao et al., 2002).
Subsequently, following assessment factors are taken into account for the final DNEL calculation: interspecies differences (4), remaining interspecies-differences (2.5), intraspecies differences (10), exposure duration (4). The resulting DNEL for long-term oral systemic effects is 2.5 mg/kg bw/day for the general population.
Dermal
For calculation of the DNEL for long-term dermal systemic effects, the dose descriptor has to be converted into a corrected starting point by route-to-route extrapolation. The absorption difference for the dermal route compared to the oral route is adjusted by the factor 0.5 due to the skin absorption classification as moderate based on the QSAR result for hexanoic acid (Danish EPA Database, 2004). This fatty acid has the highest absorption rate among all members of the category with 0.021 mg/cm² reflecting the worst case for all category members. Thus the corrected starting point for workers was 2000 mg/kg bw for the dermal route.
Subsequently, following assessment factors are taken into account for the final DNEL calculation: interspecies differences (4), remaining interspecies-differences (2.5), intraspecies differences (10), exposure duration (4). The resulting DNEL for long-term dermal systemic effects is 5.0 mg/kg bw/day for the general population.
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