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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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 07 January 1991 to 11 January 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- analytical monitoring not conducted
- 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: supporting information
- Qualifier:
- according to guideline
- Guideline:
- ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)
- Version / remarks:
- listed as ISO-guideline 7346/2 which conforms to OECD guideline 203
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- Study followed ISO-guideline 4346/2 which conforms to OECD 203, 1984.
- Deviations:
- not specified
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1 700 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- Based on the insoluble test material mixed using ultrasound and ultraturrax methods.
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 3 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- Based on the insoluble test material mixed using ultrasound and ultraturrax methods.
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- Based on the insoluble test material mixed using ultrasound and ultraturrax methods.
- Conclusions:
- Exposure of test organisms (zebra fish) to concentrations ranged from 1,000 mg/L to 10,000 mg/L of the test substance. The study reported a 96-h NOEC = 1,000 mg/L, above the threshold of concern of 100 mg/L in short-term aquatic studies. Additionally, the study reported values for the 96-h LC50 = 1,700 mg/L and the 96-h LC100 = 3,000 mg/L, although these values are not indicative of short-term toxicity to fish.
Reference
Description of key information
The key study was a semi-static acute fish toxicity test on the effects of an analogue substance on the freshwater zebra fish Danio rerio (previously Brachydanio rerio) following ISO-guideline 7346/2 which conforms to OECD Guideline 203. Exposure of test organisms (zebra fish) to test concentrations ranged from 1,000 mg/L to 10,000 mg/L. The study reported a 96-h NOEC = 1,000 mg/L, above the threshold of concern of 100 mg/L in hort-term aquatic toxicity studies. Additionally, the study reported values for the 96-h LC50 = 1,700 mg/L and the 96 -h LC100 = 3,000 mg/L, although these values are not indicative of short-term toxicity to fish.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 1 700 mg/L
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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