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EC number: 246-625-4 | CAS number: 25111-05-1
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Justification for grouping of substances and read-across
There are no data available for the skin sensitisation potential of 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1). In order to fulfil the standard information requirements set out in Annex VII, 8.3 in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted. In accordance with Article 13 (1) of Regulation (EC) No 1907/2006 “information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set put in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity, the substance listed below are selected as reference substances for hazard assessment.
Overview of skin sensitisation
CAS
Skin sensitisation
25111-05-1
Target substance
RA: CAS 68002-79-9
RA: CAS 403507-18-6
68002-79-9
not sensitising
403507-18-6
not sensitising
The above mentioned substances are considered to be similar on the basis of structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
CAS 68002-79-9
A Buehler test was performed with Fatty acids, C16-18 (even numbered) and C16-18 unsatd. (even numbered), triesters with trimethylolpropane (CAS 68002-79-9) according to OECD Guideline 406 (Pittermann, 1994) and under GLP conditions. 20 female Pirbright white guinea pigs were treated with the test substance and compared with 10 negative female control animals. Data for a positive control substance are not reported. A range finding test was conducted for dose selection. Three epidermal inductions were performed with 100% test substance in weekly intervals for 6 h under occlusive conditions. 14 days after the last induction treatment, all animals were challenged for 6 h epicutaneously with 100% test under occlusive conditions. Animals were evaluated for skin reactions 24, 48 and 72 h after challenge. In the test group, no reactions were seen at the first reading time point, while at the second and third reading time point 5 and 1 animal showed a slight skin erythema on the right flank, respectively. Slight dermal effects on the right flank were seen in one animal of the control group at the first and second reading. Thus, the test substance was found not to be skin sensitizing.
CAS 403507-18-6
The skin sensitisation potential of Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) was evaluated in guinea pigs with a Guinea pig maximisation test for skin sensitisation performed according to OECD 406 under GLP conditions (Sanders A, 2002). 10 male Dunkin-Hartley guinea pigs were treated with the test substance and compared to 5 male control animals. A 5% dilution of the test substance in arachis oil was used for intradermal induction in the shoulder region on Day 0. 100% of the test item was used for topical induction in the shoulder region on Day 7. 21 days after the last induction treatment, all animals were challenged epicutaneously with the undiluted and 75% test substance. 48 and 72 h after challenge, none of the test animals showed any skin reaction Thus, the test substance is not considered to have skin sensitizing potential.
Conclusions
As the GPMT conducted with source substance Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) and the Buehler performed with structural similar substance Fatty acids, C16-18 (even numbered) and C16-18 unsatd. (even numbered), triesters with trimethylolpropane (CAS 68002-79-9) show no evidence for a skin sensitising potential, there is no evidence for skin sensitisation properties of 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate as well.
Migrated from Short description of key information:
Skin sensitisation: not sensitising (OECD 406, and analogue approach)
Justification for selection of skin sensitisation endpoint:
Hazard assessment is conducted by means of read-across from structural analogues. The available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment (refer to the endpoint discussion for further details).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Migrated from Short description of key information:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.
Justification for classification or non-classification
The available data on skin sensitisation of structurally related substances do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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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