Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin irritation: not irritating, (OECD 404, analogue approach)
Eye irritation: not irritating, (OECD 405, analogue approach)
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for grouping of substances and read-across
There are no data available for the irritation/corrosion 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 VIII, 8.1 and VIII, 8.2 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 irritation/corrosion
CAS |
Skin irritation |
Eye irritation |
25111-05-1 Target substance |
RA: CAS 403507-18-6 RA: CAS 91050-90-7 |
RA: CAS 403507-18-6 RA: CAS 91050-90-7 |
403507-18-6 |
Not irritating |
Not irritating |
91050-90-7 |
Not irritating |
Not irritating |
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).
Skin irritation
CAS 403507-18-6
A primary dermal irritation study was performed with Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) comparable to OECD Guideline 404 and GLP (Sanders, 2002). The clipped skin of three male New Zealand White rabbits was exposed to 0.5 mL unchanged test material for 4 hours under semiocclusive conditions. The rabbits were observed for 3 days following exposure. Skin reactions were assessed 1, 24, 48 and 72 hours after removal of the test substance. Very slight to well-defined erythema was noted in all animals one hour after patch removal and at the 24 h observation time point. Very slight erythema was seen for 2/3 animals at the 48 and 72 h observations. The mean erythema score over 24, 48 and 72 hours were 1.33 for animal #1 and #3 and 0.33 for animal #2. The mean edema scores were 0.33, 0, and 1.33 for animals#1, #2 and #3 respectively. All effects were at the latest reversible within 7 days. Thus, the test material is not considered irritating to the skin in this study.
CAS 91050-90-7
A primary dermal irritation study performed with Fatty acids, C16-18, triesters with trimethylolpropane (CAS 91050-90-7) comparable to OECD Guideline 404 and GLP (Steiling, 1989). The clipped skin of three male Kleinrussen Chbb:HM rabbits was exposed to 0.5 g unchanged test material for 4 hours under semiocclusive conditions. The rabbits were observed for 3 days following exposure. Skin reactions were assessed 1, 24, 48 and 72 hours after removal of the test substance. All 3 animals displayed very slight erythema at the 24 h reading time point. In one animal, erythema remained up to 48 h. The finding was fully reversible for all 3 animals within 48 to 72 h. No edema was observed in any animal. The mean erythema scores over 24, 48 and 72 hours were 0.7 for animal #1 and 0.3 for animals #2 and #3. Thus, the test material is not considered irritating to the skin in this study.
Eye Irritation
CAS 403507-18-6
Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) was tested for its acute eye irritation potential in a study performed comparable to OECD Guideline 405 (Sanders, 2002). The undiluted test material (0.1 mL) was applied into the conjunctival sac of two male and one female New Zealand White rabbits. The animals were observed for 72 hours and reactions were assessed 1, 24, 48, and 72 hours after instillation according to the Draize scoring system. No corneal or iridal effects occurred during the study. Moderate conjuctival irritation was observed in all treated eyes one hour after application. Minimal conjuctival irritation was noted in two treated eyes (2/3 animals) at the 24 h observation time point. The mean conjunctivae scores over 24, 48 and 72 hours were 0.33 and 0 for animal #1 and #2 and 0.33 for animal ##3. Thus, the test material is not considered irritating to the eyes in this study.
CAS 91050 -90 -7
Fatty acids, C16-18, triesters with trimethylolpropane (CAS 91050-90-7) was tested for its acute eye irritation potential in a study performed comparable to OECD Guideline 405 under GLP conditions (Steiling, 1989). The undiluted test material (0.1 mL) was applied into the conjunctival sac of three male Kleinrussen, Chbb rabbits each. The animals were observed for 72 hours and reactions were assessed 1, 24, 48, and 72 hours after instillation according to the Draize scoring system. No effects were observed except redness of the conjuctivae of grade 1 in all 3 animals at reading time point 1 h only. In 2 cases this was accompanied by exudation. These effects disappeared within 24 h. Thus, the test material is not considered irritating to the eyes in this study.
Conclusions
In conclusion, the two skin irritation studies conducted with source substances Fatty acids, C16-18, triesters with trimethylolpropane (CAS 91050-90-7) and Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) indicate no skin irritating properties. Therefore, 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate is considered not to be skin irritating.
The two eye irritation studies conducted with source substances Fatty acids, C16-18, triesters with trimethylolpropane (CAS 91050-90-7) and Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) indicated no eye irritating properties. Therefore 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl oleate is not considered to be eye irritating.
Justification for selection of skin irritation / corrosion endpoint:
Hazard assessment is conducted by means of read-across from structural analogues. All 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).
Justification for selection of eye irritation endpoint:
Hazard assessment is conducted by means of read-across from structural analogues. All 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).
Justification for classification or non-classification
The available data on skin/eye irritation potential of structural 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.
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.