Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 288-509-6 | CAS number: 85736-97-6
- 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
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar physicochemical, ecotoxicological and toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: methacrylate esters
• the metabolism pathway leads to comparable products (methacrylic acid and medium chain alcohol).
Therefore, read-across from the existing physicochemical, ecotoxicity and toxicity studies on the source substances is considered as an appropriate adaptation to the standard information requirements of REACH regulation
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see “Justification for read-across” attached to IUCLID section 13
3. ANALOGUE APPROACH JUSTIFICATION
see “Justification for read-across” attached to IUCLID section 13
4. DATA MATRIX
see “Justification for read-across” attached to IUCLID section 13 - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Radiolabelling:
- no
- Vehicle:
- no
- Test organisms (species):
- other: Danio rerio
- Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Test temperature:
- 24 +/- 1°C
- Type:
- BCF
- Value:
- 37 dimensionless
- Elimination:
- yes
- Parameter:
- DT50
- Depuration time (DT):
- 1.5 h
- Elimination:
- yes
- Parameter:
- other: DT95
- Depuration time (DT):
- 6 h
- Conclusions:
- The BCF was calculated to be 37 for both test concentrations. Therefore the substance has low potential for bioaccumulation and the criteria for classification is not fulfilled.
Reference
Description of key information
An experimental study on the structural analogue 2 -Ethylhexyl methacrylate (log Kow > 4) of bioconcentration of the substance, according to OECD guideline 305 demonstrates that a rapid metabolisation occurs, this depuration prevents any significant accumulation. The measured BCF is 37.
Key value for chemical safety assessment
- BCF (aquatic species):
- 37 dimensionless
Additional information
No experimental data on Isotridecyl methacrylate are available for the assessment of bioaccumulation potential. However, a study isavailable for the source substance 2-Ethylhexyl methacrylate. A detailed justification for read-across is attached to IUCLID section 13.
An experimental study on the structural analogue 2-Ethylhexyl methacrylate (log Kow = 4.95) of bioconcentration of the substance, according to OECD guideline 305 demonstrates that a rapid metabolism occurs, this depuration prevents any significant accumulation. The measured BCF is 37.
This result is representative for the target substance, although there are differences in physicochemical properties (log Kow of the target substance > 6.5, and water solubility < 1 µg/L; log Kow of the source substance 4.95 and water solubility 3.1 mg/L). Rapid metabolism of the target substance by unspecific esterases is expected to occur, thus, bioaccumulation potential is judged to be low.
Hypothesis for the analogue approach
The read-across hypothesis relies on the close structural similarity between the source substance 2-Ethylhexyl methacrylate and the target substance Isotridecyl methacrylate. This read-across hypothesis corresponds to scenario 2 - different compounds have qualitatively similar properties - of the read-across assessment framework i.e. properties of the target substance are predicted to be quantitatively equal to those of the source substance. Namely, the structurally similar source substance 2-Ethylhexyl methacrylate predicts the environmental fate properties of the target substance Isotridecyl methacrylate.
Experimental data are summarised in the data matrix; robust study summaries are included in the Technical Dossier in the respective sections.
Therefore, read-across from the existing studies conducted with the source substance is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
A detailed justification for the proposed read-across approach is attached to Iuclid section 13.
1. Identity and characterisation of the source substance
There is close structural similarity between the source and the target substances and the identity and characterisation of these substances is unambiguous thereby giving a high level of confidence in the validity of the read across.
The target and source substances are manufactured from similar compounds by esterification of methacrylic acid with the corresponding fatty alcohol. Typical trace impurities are water and the corresponding alcohols as well as < 1 % methacrylic acid, which are not of toxicological concern.
The carbon chain length distribution of the resulting mix of long-chain aliphatic methacrylate esters mirrors the chain length distribution of the alcohol(s) used.
2. Link of structural similarities and differences with the proposed prediction
Structural similarities:
The target substance Isotridecyl methacrylate is an ester of Methacrylic acid and branched C12-C18 alcohols. The source substance 2-Ethylhexyl methacrylate contains branched alkyl chains as well, though it contains shorter C-chains (C8).
Structural differences:
There are differences in alkyl chain length between the target and the source substances.
The source substance 2-Ethylhexyl methacrylate can be expected to have a slightly higher bioavailability due to lower molecular weight compared to the target substance.
The physicochemical properties (low water solubility and high log Kow) are, however, quite similar. Thus, no large differences in bioavailability are expected.
Reliability and adequacy of the source data
All available studies have been conducted according to OECD guidelines and have been assigned a reliability of 1 or 2 as documented in the data matrix (see detailed justification for read-across attached to Iuclid section 13).
Overall, the study design of the respective source studies is adequate and reliable for the purpose of this read-across. The results of the study are adequate for classification and labelling and for risk assessment purposes.
Data availability
In a valid guideline study the bioaccumulation factor BCF of 2-Ethylhexyl methacrylate was tested in a bioconcentration study according to OECD Guideline 305 with Danio rerio at nominal concentrations of 0.06 and 0.3 mg/L under flow through conditions. Based on a range finding experiment which indicates fast metabolism, the uptake phase was scheduled for 26 hours, the depuration phase for 30 hours.
The steady state BCF was calculated to be 35 and 34 hours for the low and high test concentration, respectively. From the kinetic rates the BCF of 2-Ethylhexyl methacrylate was calculated to be 37 for both test concentrations.
Therefore, 2-Ethylhexyl methacrylate has low potential for bioaccumulation and the criteria for classification is not fulfilled.
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.