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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
Endpoint summary
Administrative data
Description of key information
Additional information
A short-term toxicity study in fish and a study on microorganisms conducted with Isotridecyl methacrylate are available as well as a long-term toxicity to aquatic invertebrates and a toxicity study to aquatic algae which were conducted with the closely related source substance Dodecyl methacrylate. A detailed justification for read-across is attached to IUCLID section 13.
Summary
Water solubility of Isotridecyl methacrylate is extremely low (< 1 µg/L). No toxicity to aquatic organisms was observed in the range of water solubility in short-term and long-term tests. Therefore, the derivation of a meaningful PNEC is not feasible.
Hypothesis for the analogue approach
The read-across hypothesis relies on the close structural similarity between the source substances 2-Ethylhexyl methacrylate and Dodecyl methacrylate and the target substance Isotridecyl methacrylate. his 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 Dodecyl methacrylate predicts the ecotoxicological properties of the target substance Isotridecyl methacrylate.
Based on the available data, including physicochemical data (water solubility and log Kow), the read-across strategy is supported by close structural analogy of the substances.
Ecotoxicological 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 ecotoxicity 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 Dodecyl methacrylate is comparable to the target substance with respect to chain length, but contains only linear C-chains.
Structural differences:
There are differences in alkyl chain length between the target and the source substances as well as differences in the presence of branched alkyl chains.
Dodecyl methacrylate is very similar to the target substance Isotridecyl methacrylate with respect to physicochemical properties (both substances have a log Kow > 6.5 and a water solubility < 1 µg/L), but the target substance Isotridecyl methacrylate contains branched alkyl chains in contrast to the source substance Dodecyl methacrylate, which contains only linear alkyl chains.
The presence of branches in close proximity to the ester function is likely to have a negative influence on hydrolysis rates due to steric hindrance. Branching in more remote positions did not have a pronounced effect on hydrolysis rates (Jones, 2002). Therefore, is can be concluded, that the presence of branched alkyl chains in the target substance is not likely to influence ester cleavage.
In general, branched fatty alcohols are not expected to exhibit higher toxicity than linear fatty alcohols, as branched fatty alcohols are abundant in the diet and are metabolised via the fatty acid α-oxidation and β-oxidation pathways.
Consistency of properties in the data matrix
The results of the acute oral toxicity studies demonstrate a low acute toxicity for the target and the source substances.
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 selected key studies are adequate for classification and labelling and for risk assessment purposes.
Data availability
Short-term toxicity to fish
An OECD 203 guideline GLP study with nominal test concentrations above 10000 mg/L showed no toxicity to Danio rerio. Therefore, it appears that saturated solutions of Isotridecyl methacrylate are non-toxic to fish.
Long-term toxicity to aquatic invertebrates
The 21-day-chronic toxicity of dodecyl methacrylate to Daphnia magna STRAUS was studied under semi static conditions according to OECD guideline 211. Daphnids were exposed to dodecyl methacrylate at a limit concentration of 10 µg/L (nominal).
This concentration is higher than the solubility in water (< 1 µg/L) but has, nevertheless, been chosen with regard to the feasibility of
attaining appropriate and detectable test concentrations at 10 µg/L.
10 test organisms, individually held were used for the limit concentration and control. At test start they were 2 to 24 hours old. The test method was semi-static. Test solutions were renewed daily.
Concentrations of dodecyl methacrylate in the stock solution, limit concentration and control of fresh (0 h) and old (24 h) media were determined via HPLC. Samples were taken and analysed on days 0, 7, 16, 20 (fresh media) and on days 1, 8, 17, 21 (old media). The test item concentrations decreased within 24 h. All effect values were given based on the time weighted mean measured concentration for the limit concentration of 5.73 µg/L.
The average number of juveniles per parent in the control group was 85 after 21 days. The reproductive output at the limit concentration was not statistically significant reduced compared to the control (One Way Analysis of Variance, p < 0.05).
The coefficient of variation around the mean number of living offspring produced per parent in the control group was 5.02 % and shows very small variances between the control replicates.
No winter eggs, males, ephippia, stillborn juveniles and aborted eggs occurred in control or test groups.
The mean day of release of first brood was 9 in the control group and the limit concentration. There was no difference between the two groups. At the limit concentration and the control group 4 broods were released during the test period.
The intrinsic rates of natural increase (IR) of the surviving parent animals accounting for generation time and offspring numbers were used for calculation of population growth. The mean IR of the surviving daphnids of the limit concentration was compared to the control by One Way Analysis of Variances (p < 0.05). There was no statistically significant difference. The intrinsic rate was comparable for the control and limit concentration.
The no observed effect concentration (NOEC) after 21 days based on reproduction capacity is the tested limit concentration of 5.73
µg/L. No statistically significant test item related effects were observed at the limit concentration when compared to the control
group. No immobilisation of parent animals occurred in the control or test group.
Water quality parameters as pH-value, dissolved oxygen, water hardness and temperature were determined to be within the acceptable limits.
In order to prove the validity of the test system and test conditions at the testing facility, an acute immobilisation test according to DIN 38412 L11 was carried out with potassium dichromate as reference item once per month. The EC50 of the reference item at 1.84 mg/L after 24 hours was within the validity range of 1.0 to 2.5 mg/L according to DIN 38412 L30.
The 21 day LC50/EC50based on reproduction/immobilisation was greater than 5.73 µg/L (mean measured concentration). The 21-day NOEC based on reproduction/immobilisation was 5.73µg/L (mean measured concentration). Production of offspring in the treated groups indicated that Dodecyl methacrylate did not have an effect on the reproduction at concentrations greater than 5.73 µg/L.
Toxicity to aquatic algae
There is one study available with acceptable reliability: Dodecyl methacrylate did not cause any inhibiting effects to Desmodesmus subspicatus after 72 h when tested at a concentration of 10 µg/l. The test concentration was approx. 10-fold higher than the water solubility (technical reasons) setting some limitation to the validity of the study.
The test concentration was chosen because it was sufficiently high above the LoQ (1 µg/l) to be measurable, with the consequence that it had to be approx. 10 fold higher than the limit of solubility.
Toxicity to microorganisms
Isotridecyl methacrylate was tested for toxicity to bacteria relevant for the biodegradation of the substance. In concentrations up to 10000 mg/l, which are far exceeding the water solubility of the substance, no inhibition of the oxygen consumption of the bacteria was observed within 180 min.
Therefore, it can be concluded that Isotridecyl methacrylate is non-toxic to bacteria.
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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