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Diss Factsheets
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EC number: 240-714-1 | CAS number: 16669-27-5
- 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 46.7 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 666.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Please refer to "Additional information"
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration from subchronic to chronic is used.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The default value for interspecies differences is used.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The repeated dose oral toxicity study was conducted according to regulatory standards and was adequately reported.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA, Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose-response for human health (Version: 2.1, November 2012).
Inhalation
Long term and acute, systemic DNEL – exposure via inhalation (workers)
Due to the extremely low vapour pressure of the solid waxen substance Docosyl methacrylate (1.96E-5 Pa), inhalation exposure is not considered as relevant. Docosyl methacrylate is unlikely to be available for inhalation exposure. Therefore, no DNEL was derived.
Long term & acute, local DNEL- exposure via inhalation (workers)
Due to the extremely low vapour pressure of the solid waxen substance Docosyl methacrylate (1.96E-5 Pa), inhalation exposure is not considered as relevant. Docosyl methacrylate is unlikely to be available for inhalation exposure. Therefore, no DNEL was derived.
Dermal
Long term, systemic DNEL- exposure via dermal route (workers)
No repeated dose dermal toxicity study with the target substance is available. Therefore, it will be necessary to obtain a long-term dermal DNEL by route-to-route extrapolation.
Step 1:PoD and most sensitive endpoint: repeated dose toxicity (oral)
The NOAEL of 1000 mg/kg bw/day derived from an OECD TG 422 study performed with the structural analogue substance Dodecyl methacrylate was used as the PoD.
Step 2:Modification into a correct starting point:
Relevant dose descriptor (NOAEL): 1000 mg/kg bw/day
In ECHA guidance R.8 it is stated that “substance specific data on absorption via the different routes are to be preferred.” Therefore, in the present situation experimental data from a dermal toxicokinetic study was used showing up to 0.3 % absorption by rat skin. This is a worst case situation as rat skin is much more permeable than human skin.
Correction for difference between human and experimental exposure conditions: 7 d rat/5 d worker
Corrected NOAEL (dermal) for workers:
= 1000 mg/kg bw/day/ 0.3 ×1.4
= 4666.7 mg/kg bw/day
Step 3:Overall AF= 100
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (worker): 5
Dose-response relationship AF: 1
Exposure duration AF: 2
In conclusion,long term systemic dermal DNEL, workers = 46.7 mg/kg bw/day
Acute, systemic DNEL- dermal exposure (workers)
As there is no evidence for critical effects from acute oral and inhalative toxicity studies, the long-term dermal DNEL will be protective also for acute dermal exposure.
Long term & acute, local DNEL- dermal exposure (workers)
The substance causes skin sensitization in experimental animals.
For these effects, a qualitative assessment was conducted: Therefore the use of gloves and the use of stringent risk management measures as outlined in ECHA guidance document Part E: Risk Characterization (Table E. 3-1) is required in order to prevent any skin contact with the test substance and thus the occurrence of skin sensitization.
Hazard to the eye-local effects (worker)
The test item is not classified for eye damage according to Regulation (EC) No 1272/2008 (CLP).
References
ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8:
Characterisation of dose [concentration]-response for human health. Version 2.1, November 2012
ECHA (2016). Guidance on information requirements and chemical safety assessment. Part E: Risk Characterisation, Version 3.0, May 2016
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:
- 15 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Please refer to "Additional information"
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is use
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration from subchronic to chronic is used.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The default value for interspecies differences is used.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the relatively homogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The repeated dose oral toxicity study was conducted according to regulatory standards and was adequately reported.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- no hazard 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:
- no hazard identified
Additional information - General Population
1. Inhalation
Long termand acute, systemic DNEL – exposure by inhalation (general population)
Docosyl methacrylate is not intended for consumer use.
Due to the extremely low vapour pressure of the solid waxen substance Docosyl methacrylate (1.96E-5 Pa), inhalation exposure is not considered as relevant. Docosyl methacrylate is unlikely to be available for inhalation exposure. Therefore, no DNEL was derived.Long term, local DNEL- exposure via inhalation (general population)
Docosyl methacrylate is not intended for consumer use.
Due to the extremely low vapour pressure of the solid waxen substance Docosyl methacrylate (1.96E-5 Pa), inhalation exposure is not considered as relevant. Docosyl methacrylate is unlikely to be available for inhalation exposure. Therefore, no DNEL was derived.
2. Dermal
Docosyl methacrylate is not intended for consumer use.
No repeated dose dermal toxicity study with the target substance is available. Therefore, it will be necessary to obtain a long-term dermal DNEL by route-to-route extrapolation.Long term, systemic DNEL- exposure via dermal route (general population)
Step 1:PoD and most sensitive endpoint: repeated dose toxicity (oral)
The NOAEL of 1000 mg/kg bw/day derived from an OECD TG 422 study performed with the structural analogue substance Dodecyl methacrylate was used as the PoD.
Step 2:Modification into a correct starting point:
Relevant dose descriptor (NOAEL): 1000 mg/kg bw/day
In ECHA guidance R.8 it is stated that “substance specific data on absorption via the different routes are to be preferred.” Therefore, in the present situation experimental data from a dermal toxicokinetic study was used showing up to 0.3 % absorption by rat skin.
Correction for difference between human and experimental exposure conditions: 7 d rat/7 d general population
Corrected NOAEL (dermal) for workers:
= 1000 mg/kg bw/day/ 0.3 ×1
= 3000 mg/kg bw/day
Step 3:Overall AF= 200
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (worker): 10
Dose-response relationship AF: 1
Exposure duration AF: 2
In conclusion,long term systemic dermal DNEL, workers = 15 mg/kg bw/day
Acute, systemic DNEL- dermal exposure (general population)
Docosyl methacrylate is not intended for consumer use.
As there is no evidence for critical effects from acute oral and inhalative toxicity studies, the long-term dermal DNEL will be protective also for acute dermal exposure.Long term & acute, local DNEL- dermal exposure (general population)
A DNEL long term/acute - local effects is not established because the substance is not classified dangerous for skin/eye irritation/corrosion and skin sensitisation according to Regulation (EC) No 1272/2008.
Long term & acute, systemic DNEL- exposure by oral route (general population)
Since the substance is readily biodegradable and expected to be rapidly metabolized in rodents and humans, secondary poisoning is unlikely to be a relevant route of exposure. Additionally, acute oral toxicity is low.
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