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Diss Factsheets
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EC number: 810-760-2 | CAS number: 149855-64-1
- 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:
- 17.6 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 Technical Rport No. 110
- Overall assessment factor (AF):
- 12
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 211 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There are no relvant experimantl data on repeated exposure by inhalation. The recommended approach using oral data and assuming the same absorption for inhalation and oral route ist used.
- 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 ist based on a 13-week study. AF for extrapolation from subchronic to chronic (ECHA)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully coverd by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- There is no evidende for species differences in the general mode of action or kinetics.
- AF for intraspecies differences:
- 3
- Justification:
- Known mode of action involving ubiquious and non-specific enzyme systems (carboxylesterases, tricarboxylic acid cycle) makes a lower variability likely (ECETOC Technical Report No. 110)
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 2
- Justification:
- Data based on the read-across substance.
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:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC Technical Report No.110
- Overall assessment factor (AF):
- 48
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on rpeated dermal exposure.
- AF for dose response relationship:
- 1
- Justification:
- The NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- The NOAEC ist based on a 13-week study. AF for extrapolation from subchronic to chronic (ECHA)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to humas AF 4 (ECHA)
- AF for other interspecies differences:
- 1
- Justification:
- There is no evidende for species differences in the general mode of action or kinetics.
- AF for intraspecies differences:
- 3
- Justification:
- Known mode of action involving ubiquious and non-specific enzyme systems (carboxylesterases, tricarboxylic acid cycle) makes a lower variability likely (ECETOC Technical Report No. 110)
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 2
- Justification:
- Data based on the read-across substance.
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
General
DNEL derivation for the substance is performed under consideration of the recommendations of ECHA REACH Guidance (2010) and ECETOC (2003). In view of the data used for evaluation, the "quality of whole database factors" is considered to amount to a value of 1, and is thus not shown in the calculations presented below.
Acute- systemic effects
A short-term DNEL oral is not required as the acute oral toxicity of 2-propylheptyl methacrylate is considered low. It was not classified and labelled for acute systemic toxicity, according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
Acute/short-term and long-term exposure - local effects
Skin irritation/corrosion, eye irritation and sensitization:
The test item is not classified and labelled for skin irritation/corrosion, eye irritation or sensitization according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
However, the monoalkyl or monoaryl or monoalkylaryl esters of methacrylic acid are classified as irritating to eyes, respiratory tract and skin with R36/37/38 according to Directive 67/548/EEC (DSD) and with H315, H319 and H335 according to Regulation (EC) No 1272/2008 (CLP).
A quantitative risk assessment is done.
Long-term exposure-systemic effects
Inhalation exposure
In order to derive the worker DNEL (long-term dermal exposure), the NOAEL assessed in a subchronic 90-day study gavage in rats with 2-ethylhexyl methacrylate (BASF SE, 2008) is identified as the relevant dose descriptor (NOAEL = 120 mg/kg bw).The oral NOAEL was converted to an inhalation NOAEC, assuming 100 % absorption via the lung and 100 % absorption via the oral route.
Inhalation NOAEC = oral NOAEL x 1/sRV(rat) x ABSoral(rat)/ABSinhalation(human) x sRV(human)/wRV(human)
With
Oral NOAEL: 120 mg/kg bw/day
sRV(rat): 0.38 m³/kg bw (8 hours) [standard respiratory volume of the rat]
ABSoral(rat)/ABSinhalation(human): 1 [ratio of oral absorption in the rat to inhalative absorption in the human]
sRV(human)/wRV(human): 6.7 m3/10 m³ [ratio of human standard respiratory volume to worker respiratory volume]
Accordingly, the oral NOAEL of 120 mg/kg bw/day is converted in an inhalation NOAEC of 211 mg/m³.
Taking the above mentioned assessment factors into account, the following worker DNEL is:
Worker DNEL (inhalation exposure)
= 211 mg/m3 / (1 x 2 x 1 x 1 x 3 x 1 x 2) = 211 mg/m3 / 12 =17,6 mg/m³
Dermal exposure
In order to derive the worker DNEL (long-term dermal exposure), the NOAEL assessed in an subchronic 90-day gavage study in rats with 2-ethylhexyl methacrylate (BASF SE, 2008) is identified as the relevant dose descriptor (NOAEL = 120 mg/kg bw). The lead effects observed were signs of non-specific, general systemic toxicity at 360 mg/kg body weight/day in both males and females. Bases on the log Pow only a low dermal uptake can be expected.
The worker DNEL (long-term dermal exposure) is calculated as follows:
Taking the above mentioned assessment factors into account, the following worker DNEL is:
Worker DNEL (dermal exposure) = 120 mg/kg bw/d / (1 x 2 x 4 x 1 x 3 x 1 x 2) = 120 mg/kg bw/d / 48 =2,5 mg/kg bw/d
References
- ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health.Version 2. ECHA-2010 -G-19 –EN.
- ECETOC (2010). Technical Report 110.Guidance on assessment factors to derive a DNEL.
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
The test substance was not classified and labelled regarding oral, dermal and inhalative toxicity.
Further no consumer use is intended.
Therefore no DNEL`s were derived for the general population risk assessment for 2 -propylheptyl methacrylate.
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.
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