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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 221-657-1 | CAS number: 3179-47-3
- 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
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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:
- 2.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC 2010
- Overall assessment factor (AF):
- 47.1
- Dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 15.28 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Factor 2 forOral to inhalation route-to-route extrapolation (ECHA R8, 2012)
Factor 0.38 m3/kg as Correction for rat standard breathing volume (ECHA R8, 2012)
Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (10 m3/6.7 m3;ECHA R8, 2012).
- AF for dose response relationship:
- 1
- Justification:
- The NOAEC is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- The NOAEC is based on a 13-week study. AF for extrapolation from Sub-chronic to chronic (ECHA R8, 2012).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling rat to humans as intraspecies adjustment is accounted for in relative breathing volumes (ECHA R8, 2012).
- AF for other interspecies differences:
- 1
- Justification:
- Not justified due to known mode of action involving ubiquitous and non-specific enzyme systems (carboxylesterases, tricarboxylic acid cycle).
- AF for intraspecies differences:
- 3
- Justification:
- Known mode of action involving ubiquitous and non-specific enzyme systems (carboxylesterases, tricarboxylic acid cycle) makes a lower variability likely, hence the AF of 5 by ECETOC (2010) is sufficiently conservative for workers.)
- AF for the quality of the whole database:
- 1
- Justification:
- The key studies were of high quality, being rated K1. No adjustment is required.
- AF for remaining uncertainties:
- 1
- Justification:
- Default value of 2.5 for remaining differences not justified (ECETOC, 2010).
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:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC 2010
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The NOEL is reliable. No adjustment required.
- AF for differences in duration of exposure:
- 2
- Justification:
- The NOAEC is based on a 13-week study. AF for extrapolation from Sub-chronic to chronic (ECHA 2008).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to humans AF 4 (ECHA 2008).
- AF for other interspecies differences:
- 1
- Justification:
- The substances are metabolised via general metabolic pathways that are common and very similar to rodents and humans and the absence of any specific target organs indicating a specific MOA at high concentrations there is no reason to believe that an additional AF of 2.5 for remaining diferences is justified.
- AF for intraspecies differences:
- 3
- Justification:
- Known mode of action involving ubiquitous and non-specific enzyme systems (carboxylesterases, tricarboxylic acid cycle) makes a lower variability likely, hence the AF of 5 by ECETOC (2010) is sufficiently conservative 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. 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:
- 1
- Justification:
- No remaining uncertainties.
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The derivation of the DNEL for Isodecyl methacrylate is based on the analogue substance 2 -Ethylhexyl methacrylate. The repeated dose toxicity of the latter is considered as the worst case. Increasing molecular weight of the alkyl methacrylate esters with an alcohol moiety chain length of C8 and above is leading to lower toxicity due to decreasing volatility, bioavailability and slower metabolism.
Long-term exposure (inhalation) - local effects
Based on phys.-chem- properties and toxicokinetic information, the inhalation pathway is not considered a relevant route of exposure for Isodecyl methacrylate.
Long-term exposure (inhalation) -systemic effects
In a subchronic 90-day gavage study in rats with 2-Ethylhexyl methacrylate the lead effects observed were signs of non-specific, general systemic toxicity at 360 mg/kg body weight/day in both males and females.
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEC: 120 mg/kg bw/d |
NOAEC for rats,for 13 weeks |
Step 2) Modification of starting point |
1 |
No adjustment is necessary. |
Step 3) Assessment factors |
|
|
Interspecies |
4 |
Allometric scaling rat to humans AF 4 (ECHA 2008). |
Intraspecies |
3 |
Known mode of action involving ubiquitous and non-specific enzyme systems (carboxylesterases, tricarboxylic acid cycle) makes a lower variability likely, hence the AF of 5 by ECETOC (2010) is sufficiently conservative for workers.) |
Exposure duration |
2 |
The NOAEC is based on a 13-week study. AF for extrapolation fromSub-chronic to chronic (ECHA 2008). |
Dose response |
1 |
The NOAEC is reliable. No adjustment is required. |
Quality of database |
1 |
The key study was conducted according to modern regulatory standards and was adequately reported. 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. |
DNEL |
Value |
|
NOAEC: 120 mg/kg bw/d |
Using a total factor (POD modifier and AF) of 24 (1 x 1 x 4 x 3 x 2 x 1 x 1)a DNELlong-term,workerof 5.0mg/kg bw/d is derived. |
Long-term exposure (oral/dermal exposure) - systemic effects
In a subchronic 90-day gavage study in rats with 2-EHMA the lead effects observed were signs of non-specific, general systemic toxicity at 360 mg/kg body weight/day in both males and females.
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEC: 120 mg/kg bw/d |
NOAEC for rats,for 13 weeks |
Step 2) Modification of starting point |
1 |
No adjustment is necessary. |
Step 3) Assessment factors |
|
|
Interspecies |
4 |
Allometric scaling rat to humans AF 4(ECHA R8, 2012) . 2.5 for remaining differences not justified (ECETOC, 2010). |
Intraspecies |
3 |
Default AF (ECETOC, 2010) |
Exposure duration |
2 |
The NOAEC is based on a 13-week study. AF for extrapolation fromSub-chronic to chronic (ECHA R8, 2012) . |
Dose response |
1 |
The NOAEC is reliable. No adjustment is required. |
Quality of database |
1 |
The key studies were of high quality, being rated K1. No adjustment is required. |
DNEL |
Value |
|
NOAEC: 120 mg/kg bw/d |
Using a total factor (POD modifier and AF) of 24 (1 x 1 x 4 x 3 x 2 x 1 x 1)a DNELlong-term,workerof 5.0mg/kg bw/d is derived. |
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:
- 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
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
There are only professional and industrial uses of the monomer. For the general population the only known uses are all with (co-)polymers only.
The substance is not added to food. Additionally, since the analogue substance 2 -Ethylhexyl methacrylate exhibits a low BCF(37) in fish, is readily biodegradable (failing 10-day window) and rapidly metabolised in rodents and humans, secondary poisoning by the oral route is unlikely to be a relevant route of exposure.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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