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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: - | CAS number: -
- 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
Weight-of-Evidence for acute oral toxicity was obtained from read-across substances. Epoxidized Soybean Oil (ESBO), Epoxidized 2 -Ethylhexyl ester of tall oil fatty acid (ETP) and 2-Ethylhexyl 9,10-epoxystearate (EMS). The value of 22500 mg/kg bw was obtained as conservative value for oral toxicity. The value of 20000 mg/kg bw was obtained as conservative value for dermal toxicity. Both values exceed the limit dose.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to valid methods and considered reliable, adequate and relevant.
- Principles of method if other than guideline:
- No data
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 22.5 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- > 14 - < 36
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 of Epoxidized Soybean Oil in rats was reported to be 22.5 mL/kg bw.
- Executive summary:
The oral LD50 of Epoxidized Soybean Oil (ESBO) in rats was reported to be 22.5 mL/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 22 500 mg/kg bw
- Quality of whole database:
- Reliable
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to valid methods and considered reliable, adequate and relevant.
- Principles of method if other than guideline:
- No data
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 20 mL/kg bw
- Based on:
- test mat.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 of Epoxidized soybean oil in rabbits indicates a low order of toxicity.
The dermal LD50 is >20 mL/kg. - Executive summary:
The dermal LD50 of Epoxidized soybean oil (ESBO) in rabbits is >20 mL/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 20 000 mg/kg bw
- Quality of whole database:
- Reliable
Additional information
Weight-of-Evidence for acute oral toxicity was obtained from read-across substances. A read-across justification based on molecular, physicochemical and toxicological properties was written as a separate document provided under Section 13 (Assessment reports). The following data were used:
- The oral LD50 of Epoxidized Soybean Oil (ESBO) in rats was 22.5 mL/kg bw.
- The oral LD50 of Epoxidized 2 -Ethylhexyl ester of tall oil fatty acid (ETP) in rats was 22.6 mL/kg bw.
- The oral LD50 of 2-Ethylhexyl 9,10-epoxystearate (EMS) in rats was 30.8 mL/kg bw.
All read-across studies indicate that there is no acute toxicity after oral administration in rats. The lowest LD50 value of 22.5 mL/kg bw is used for further evaluation. Taking into account a relative density of 1.01 g/mL (ECHA Registered Database), this corresponds with 22.73 mg/kg bw. This exceeds the limit dose for acute oral toxicity (2000 mg/kg bw).
Weight-of-Evidence for acute dermal toxicity was also obtained from read-across substances. A read-across justification based on molecular, physicochemical and toxicological properties was written as a separate document provided under Section 13 (Assessment reports). The following data were used:
- The oral LD50 of Epoxidized Soybean Oil (ESBO) in rats was >20 mL/kg bw.
- The oral LD50 of Epoxidized 2 -Ethylhexyl ester of tall oil fatty acid (ETP) in rats was >20 mL/kg bw.
- The oral LD50 of 2-Ethylhexyl 9,10-epoxystearate (EMS) in rats was >20 mL/kg bw.
All read-across studies indicate that there is no acute toxicity after dermal administration in rats. The LD50 value >20 mL/kg bw is used for further evaluation. Taking into account a relative density of 1.01 g/mL (ECHA Registered Database), this corresponds with >20.2 g/kg bw. This exceeds the limit dose for acute dermal toxicity (2000 mg/kg bw).
The oral route was considered most appropriate for the hazard characterization of PLSG-5. Inhalation of the substance is unlikely as the vapour pressure is very low. Skin contact may be likely, however skin absorption is considered to be very low (see Toxicokinetics).
Justification for selection of acute toxicity – oral endpoint
Weight-of-Evidence from read-across substances; this endpoint has the lowest LD50 value.
Justification for selection of acute toxicity – dermal endpoint
Weight-of-Evidence from other read-across substances., with similar LD50 values.
Justification for classification or non-classification
Based on the results and according to the EC criteria for classification and labelling according to CLP regulation (EC No. 1272/2008 of 16 December 2008), 'fatty acids, C16 -18 and C18-unsaturated isopentyl esters, epoxidized' does not have to be classified and has no obligatory labelling requirement for acute oral and dermal toxicity.
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.