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EC number: 205-471-8 | CAS number: 141-23-1
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 20 April 2010 to 23 April 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The analogue approach is used for the hazard assessment of toxicological, eco-toxicological and environmental fate endpoints for the registration of 12-hydroxstearate methyl ester (CAS 141-23-1). The hypothesis is that data can be read-across between this ester and its structural analogues, based on structural similarity and which cause the same type of effect(s) in physical and biological systems (Scenario 2 of the Read-Across Assessment Framework (RAAF, ECHA, 2015). The primary fatty acid ester in this read-across for environmental fate and ecotoxicological endpoints is methyl myristate (C14), as this substance is well-studied with high-quality experimental data. Supplemental analogues are used which contribute understanding of the effects of other structural features not contained in the two primary analogues.
The substance and its analogue have not been shown to exhibit toxicity to aquatic organisms (based on short-term studies on all three trophic levels) or be inhibitory to degradative micro-organisms. Both the substance and its analogue have been shown to be readily biodegradable and are not expected to be highly persistent in the environment. And, although both substances exhibit low solubility and a high octanol-water partition coefficient, neither substance is expected to bioaccumulate and pose a concern for food chain exposures, due to the metabolism by carboxylesterases and lipases in vertebrate and invertebrate systems.
There are no GHS classifications for 12-hydroxstearate methyl ester for endpoints which are reliant on read-across. There is a high degree of confidence that hazards for these endpoints are not underestimated, based on a strong weight of evidence from multiple data sources.
Read-across data, all evaluated as reliable according to Klimisch scores of 1 or 2, were used to estimate the toxicity of the registered substance for fulfilling the data requirements of the REACH registration and classifying potential hazards. This read-across approach is adequate for the purposes of risk assessment and classification and labeling. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- yes
- Remarks:
- Test vessels with a volume of 60 ml (filled with 50 ml) were used in the final test. Size and volume of the test vessels are not critical as long as a minimum volume of 2 ml per organism is available; did not adversely affect study integrity.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 2008
- Deviations:
- yes
- Remarks:
- Test vessels with a volume of 60 ml (filled with 50 ml) were used in the final test. Size and volume of the test vessels are not critical as long as a minimum volume of 2 ml per organism is available; did not adversely affect study integrity.
- Qualifier:
- according to guideline
- Guideline:
- ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
- Version / remarks:
- 1996
- Deviations:
- yes
- Remarks:
- Test vessels with a volume of 60 ml (filled with 50 ml) were used in the final test. Size and volume of the test vessels are not critical as long as a minimum volume of 2 ml per organism is available; did not adversely affect study integrity.
- GLP compliance:
- yes
- Test organisms (species):
- Daphnia magna
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- 48 hr EC50 exceeded 100 mg/L for a glass fibre solution prepared using a WSF with a loading rate of 100 mg/L corresponding to an initial measured concentration of 0.02 mg/L or lower (i.e., the maximum solubility in test medium).
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mol/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Conclusions:
- The test substance did not induce acute immobilisation of Daphnia magna exposed to a Water Soluble Fraction (WSF) solution prepared using a glass fibre filtered solution with a loading rate of 100 mg/L and dilutions containing 10%, 18%, 32% and 56% of the filtrate. The 48-h NOEC was 100 mg/L, the 48-h LOEC was > 100 mg/L and the 48-hr EC50 was > 100 mg/L.
Reference
Description of key information
The key study was a semi-static acute invertebrate toxicity test on the effects of the substance on the freshwater invertebrate Daphnia magna following OECD Guideline 202. Acute immobilisation of Daphnia magna was not observed after 48 h exposure to the substance at a series of test concentrations. The initial test solution was prepared as the Water Soluble Fraction (WSF) at a loading rate of 100 mg/L using a glass fibre filter; subsequent dilutions established test solutions containing 10%, 18%, 32% and 56% of the initial WSF solution. The 48-h NOELR was 100 mg/L, the 48-h LOELR was > 100 mg/L and the 48-hr EC50 was > 100 mg/L.
Key value for chemical safety assessment
Additional information
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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