Registration Dossier
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EC number: 941-174-6 | 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:
- no hazard 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:
- 56.25 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 400
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 22 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long term dermal studies are not available. The long term systemic dermal DNEL has been derived from the oral 91 day repeated dose toxicity study. Based on toxicokinetic data, an assessment factor for the route to route extrapolation (oral to dermal) of 45 has been applied (for details see section "Additional information").
- AF for dose response relationship:
- 1
- Justification:
- In a reliable, adequate and relevant subchronic study in rats there were no toxicological effects relevant to humans up to and including the highest administered dose of 500 mg/kg bw/d. The NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default assessment factor for extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default allometric scaling factor for rat to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The key study was conducted according to modern regulatory standards and was adequately reported. The tested dose range included the highest administered dose of 500 mg/kg bw/day. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
- AF for remaining uncertainties:
- 4
- Justification:
- To account for a lower sensitivity and the limited scope of the repeated dose toxicity studies for detecting effects on reproductive organs an additional assessment factor of 2 was applied. A further factor of 2 has been applied for read-across: no RDT/reprotox studies are available for the registered substance.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- low hazard (no threshold derived)
Additional information - workers
Selection of the relevant dose descriptors:
Oral:
NOAEL 500 mg/kg bw/day: 90-day study, rat, oral (gavage); highest dose tested, read-across from MDEA-Esterquat C16 -18 and C18 unsatd.
NOAEL 1000 mg/kg bw/day: Developmental toxicity study, rat, oral (gavage); highest dose tested, read-across from MDEA-Esterquat C16 -18 and C18 unsatd.
Modification of the relevant dose descriptors to the correct starting point:
Oral absorption
No data exist on differences in bioavailability following oral or dermal exposure between experimental animals and humans, and a similar bioavailability is assumed by default.
Oral to dermal
For systemic effects available toxicokinetic data will be taken into account for the route to route extrapolation.
Absorption after oral application: 48 ± 4 % (read-across from MDEA-Esterquat C16 -18 and C18 unsatd.)
Absorption after dermal application: 0.3 % (2 ± 0.8 µg/cm²) for paste formulation (101 g/L); 0.9 % (0.03 ± 0.02 µg/cm²) for aqueous dilution (0.311 g/L)
Proposed assessment factor for the route to route extrapolation (oral to dermal): 45
A factor of 48 would have suggested a higher accuracy than the data actually provide; the use of a factor of 40 would result in an overly conservative DNEL, especially as already very conservative assessment factors are used. Thus, a factor of 45 is considered appropriate for route to route extrapolation oral to dermal.
DERIVATION OF DNELs
DNELs long term systemic effects (including effects on fertility)
Uncertainties | AF
| Justification |
Allometric scaling (dermal) | 4 | Allometric scaling rat to humans AF 4 (ECHA 2008). |
Remaining interspecies differences | 2.5 | Default AF for remaining interspecies differences |
Intraspecies differences | 5 | Default AF for workers |
Differences in duration of exposure | 2 | Default assessment factor for extrapolation from subchronic to chronic |
Dose response and endpoint specific/severity
| 1 | In a reliable, adequate and relevant subchronic study in rats there were no toxicological effects relevant to humans up to and including the highest administered dose of 500 mg/kg bw/d. The NOAEL is reliable. No adjustment is required.
|
Quality of whole database | 1 | The key study was conducted according to modern regulatory standards and was adequately reported. The tested dose range included the highest administered dose of 500 mg/kg bw/day. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
|
Remaining uncertainties | 4 | To account for a lower sensitivity and the limited scope of the repeated dose toxicity studies for detecting effects on reproductive organs an additional assessment factor of 2 was applied. A further factor of 2 has been applied for read-across: no repeated dose toxicity studies/reproductive toxicity studies are available for the registered substance. |
No DNEL for the inhalation route was derived as inhalation is not a relevant route of exposure to MDIPA-Esterquat C16-18 and C18 unsatd. due to the physicochemical properties of the substance and the nature of its uses.MDIPA-Esterquat C16-18 and C18 unsatd. is a waxy solid paste. Generation of inhalable particles such as dust or aerosols is therefore not to be expected. Vaporization needs not to be considered due to the substance’s very low vapour pressure of < 8.4E-07 Pa at 20°C. The generation of dusts and aerosols is prevented by appropriate RMMs, and the substance is not used in spray applications.
Worker-DNEL long-term for dermal route (systemic): 56.25 mg/kg bw/d
Start value: 500 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 22500 mg/kg bw/d
Overall AF 4*2.5*5*2*1*1*4 = 400
This DNEL does not address the potential for local irritation. The risk characterisation will consider whether specific risk management measures are necessary to protect against local effects.
Modification of the relevant dose descriptors to the correct starting point (NOAEL from oral developmental toxicity study, OECD 414):
Uncertainties | AF
| Justification |
Allometric scaling (dermal) | 4 | Allometric scaling rat to humans AF 4 (ECHA 2008). |
Remaining interspecies differences | 2.5 | Default AF for remaining interspecies differences |
Intraspecies differences | 5 | Default AF for workers |
Differences in duration of exposure | 1 | No assessment factor for time extrapolation is applied as the susceptible window is fully covered |
Dose response and endpoint specific/severity
| 1 | In a reliable, adequate and relevant OECD 414 study in rats there were no toxicological effects relevant to humans up to and including the highest administered dose of 1000 mg/kg bw/d. The NOAEL is reliable. No adjustment is required.
|
Quality of whole database | 1 | The key study was conducted according to modern regulatory standards and was adequately reported. The tested dose range included thehighest administereddose of 1000 mg/kg bw/day. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
|
Remaining uncertainties | 2 | A factor of 2 has been applied for read-across: no repeated dose toxicity studies/reproductive toxicity studies are available for the registered substance. |
Worker-DNEL long-term for dermal route (systemic): 450 mg/kg bw/d
Start value: 1000 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 45000 mg/kg bw/d
Overall AF 4*2.5*5*1*1*1*2 = 100
This DNEL does not address the potential for local irritation. The risk characterisation will consider whether specific risk management measures are necessary to protect against local effects.
The DNELs for developmental toxicity are higher than those for fertility.Thus, the fertility-DNELs are also protective for development.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard 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:
- 28.13 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 800
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 22 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long term dermal studies are not available. The long term systemic dermal DNEL has been derived from the oral 91 day repeated dose toxicity study. Based on toxicokinetic data, an assessment factor for the route to route extrapolation (oral to dermal) of 45 has been applied (for details see section "Additional information"
- AF for dose response relationship:
- 1
- Justification:
- In a reliable, adequate and relevant subchronic study in rats there were no toxicological effects relevant to humans up to and including the highest administered dose of 500 mg/kg bw/d. The NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default assessment factor for extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default allometric scaling factor for rat to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The key study was conducted according to modern regulatory standards and was adequately reported.
The tested dose range included the highest administered dose of 500 mg/kg bw/day. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor. - AF for remaining uncertainties:
- 4
- Justification:
- To account for a lower sensitivity and the limited scope of the repeated dose toxicity studies for detecting effects on reproductive organs an additional assessment factor of 2 was applied. A further factor of 2 has been applied for read-across: no RDT/reprotox studies are available for the registered substance.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.63 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 800
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- In a reliable, adequate and relevant subchronic study in rats there were no toxicological effects relevant to humans up to and including the highest administered dose of 500 mg/kg bw/d. The NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default assessment factor for extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default allometric scaling factor for rat to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The key study was conducted according to modern regulatory standards and was adequately reported. The tested dose range included the highest administered dose of 500 mg/kg bw/day. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
- AF for remaining uncertainties:
- 4
- Justification:
- To account for a lower sensitivity and the limited scope of the repeated dose toxicity studies for detecting effects on reproductive organs an additional assessment factor of 2 was applied. A further factor of 2 has been applied for read-across: no RDT/reprotox studies are available for the registered substance.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Selection of the relevant dose descriptors:
Oral:
NOAEL 500 mg/kg bw/day: 90-day gavage study rat; highest dose tested
NOAEL 1000 mg/kg bw/day: Developmental toxicity study rat gavage
Modificationof the relevant dose descriptors to the correct starting point:
Oral absorption
No data exist on differences in bioavailability following oral or dermal exposure between experimental animals and humans, and a similar bioavailability is assumed by default.
Oral to dermal
For systemic effects available toxicokinetic data will be taken into account for the route to route extrapolation.
Absorption after oral application: 48 ± 4 % (read-across from MDEA-Esterquat C16 -18 and C18 unsatd.)
Absorption after dermal application: 0.3 % (2 ± 0.8μg/cm²) for paste formulation (101 g/L); 0.9 % (0.03 ± 0.02μg/cm²) for aqueous dilution (0.311 g/L)
Proposed assessment factor for the route to route extrapolation (oral to dermal): 45
A factor of 48 would have suggested a higher accuracy than the data actually provide; the use of a factor of 40 would result in an overly conservative DNEL, especially as already very conservative assessment factors are used. Thus, a factor of 45 is considered appropriate for route to route extrapolation oral to dermal.
DERIVATION OF DNELs
DNELs long term systemic effects (including effects on fertility)
Uncertainties | AF | Justification |
Allometric scaling (dermal, oral)
| 4 | Allometric scaling rat to humans AF 4 (ECHA 2008). |
Remaining interspecies differences
| 2.5 | Default AF for remaining interspecies differences
|
Intraspecies differences
| 10 | Default AF for general population
|
Differences in duration of exposure
| 2 | Default assessment factor for extrapolation from subchronic to chronic
|
Dose response and endpoint specific/severity
| 1 | In a reliable, adequate and relevant subchronic study in rats there were no toxicological effects relevant to humans up to and including the highest administered dose of 500 mg/kg bw/d. The NOAEL is reliable. No adjustment is required.
|
Quality of whole database
| 1 | The key study was conducted according to modern regulatory standards and was adequately reported. The tested dose range included the highest administered dose of 500 mg/kg bw/day. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
|
Remaining uncertainties
| 4 | To account for a lower sensitivity and the limited scope of the repeated dose toxicity studies for detecting effects on reproductive organs an additional assessment factor of 2 was applied. A further factor of 2 has been applied for read-across: no repeated dose toxicity studies/reproductive toxicity studies are available for the registered substance. |
General population-DNEL long-term for dermal route (systemic): 28.13 mg/kg bw/d
Start value: 500 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 22500 mg/kg bw/d
Overall AF 4*2.5*10*2*1*1*4 = 800
This DNEL does not address the potential for local irritation. The risk characterisation will consider whether specific risk management measures are necessary to protect against local effects.
General population-DNEL long-term for oral route (systemic): 0.63 mg/kg bw/d
Start value: 500 mg/kg bw/d
Route of original study: oral
Overall AF 4*2.5*10*2*1*1*4 = 800
Modification of the relevant dose descriptors to the correct starting point (NOAEL from oral developmental toxicity study, OECD 414):
Uncertainties | AF | Justification |
Allometric scaling (dermal, oral)
| 4 | Allometric scaling rat to humans AF 4 (ECHA 2008). |
Remaining interspecies differences
| 2.5 | Default AF for remaining interspecies differences
|
Intraspecies differences
| 10 | Default AF for general population
|
Differences in duration of exposure
| 1 | No assessment factor for time extrapolation is applied as the susceptible window is fully covered |
Dose response and endpoint specific/severity
| 1 | In a reliable, adequate and relevant OECD 414 study in rats there were no toxicological effects relevant to humans up to and including the highest administered dose of 1000 mg/kg bw/d. The NOAEL is reliable. No adjustment is required. |
Quality of whole database
| 1 | The key study was conducted according to modern regulatory standards and was adequately reported. The tested dose range included the highest administered dose of 1000 mg/kg bw/day. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor. |
Remaining uncertainties | 1 | No uncertainties remaining |
General population-DNEL long-term for dermal route (systemic): 450 mg/kg bw/d
Start value: 1000 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 45000 mg/kg bw/d
Overall AF 4*2.5*10*1*1*1*1 = 100
General population-DNEL long-term for oral route (systemic): 10 mg/kg bw/d
Start value: 1000 mg/kg bw/d
Route of original study: oral
Overall AF 4*2.5*10*1*1*1*1 = 100
The DNELs for developmental toxicity are higher than those for fertility. Thus, the fertility-DNELs are also protective for development.
The critical long term DNELs for general population are:
DNELgeneral population fertility for dermal route systemic of 28.13 mg/kg bw/day
DNELgeneral population fertility for oral route systemic of 0.63 mg/kg bw/day
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