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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- Sensitization of guinea pigs was determined by a technique consisting of 8 intracuaneous injections (3 per week on alternate days) of 0.1 mL of the diluted epoxymaterial. A 3-week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- No. of animals per dose:
- 20
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Test material was negative in the guinea pig sensitisation test.
- Executive summary:
Epoxidized Soybean Oil (ESBO) was applied in guinea pigs by a technique consisting of 8 intracutaneous injections (3 per week on alternate days) of 0.1 mL of the diluted epoxymaterial. A 3 -week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter. No animals were sensitised of the 20 animals tested.
Reference
0 animals were sensitized; 20 animals were tested.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Weight-of-Evidence for skin sensitisation 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:
- Epoxidized Soybean Oil (ESBO) was applied in guinea-pigs by a technique consisting of 8 intracutaneous injections (3 per week on alternate days) of 0.1 mL of the diluted epoxymaterial. A 3-week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter. No animals were sensitised of the 20 animals tested.
- 2-Ethylhexyl stearate mono-epoxidized (ESM) was applied in guinea-pigs by a technique consisting of 8 intracutaneous injections (3 per week on alternate days) of 0.1 mL of the diluted epoxymaterial. A 3-week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter. No animals were sensitised of the 20 animals tested.
In conclusion, both studies wiht read-across substances indicate that also for PLSG-5 there is no potential for skin sensitisation after repeated intracutaneous induction followed by challenge.
Migrated from Short description of key information:
Weight-of-Evidence for skin sensitisation was obtained from read-across substances Epoxidized Soybean Oil (ESBO) and 2-Ethylhexyl 9,10-epoxystearate (EMS). Both substances were negative for sensitisation when applied in guinea-pigs by a technique consisting of 8 intracutaneous injections (3 per week on alternate days) of 0.1 mL of the diluted epoxymaterial followed by a 3-week incubation period and challenge. Therefore, 'fatty acids, C16 -18 and C18-unsaturated isopentyl esters, epoxidized' was also considered to have no skin sensitisation potential.
Justification for selection of skin sensitisation endpoint:
Weight-of-Evidence from read-across substances, with similar values.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 sensitisation potential.
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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