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EC number: 288-306-2 | CAS number: 85711-46-2
- 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
The potential of a structural analogue to cause skin and eye irritation was determined by application of the undiluted substance onto skin and into eyes of rabbits (OECD guideline 404 and 405, under GLP conditions). Effects on kin or eyes, respectively, were scored up to 72h and observed for 14d. The substance caused opacitiy, iritis as well as chemosis and redness in eyes which was not fully reversible within observation period. Application onto skin caused erythema and edema which were also not fully reversible. The material is therefore considered to be irritating to skin and eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Read across justification
The test item is an UVCB and composes mainly of modified fatty acids from sun flower oil (mSOFA) and, to a minor part, of modiefied fatty acids from tall oil (mTOFA). The fatty acids obtained from tall oil and sun flower oil are of comparable chain lenghth and are modified by the same reaction step. In contrast to mTOFA, mSOFA is also produced solely by the very same reaction as the UVCB and consists therefore of the same reaction products and similar impurities. Furthermore, mSOFA was intentively examined for its toxicological properties. Thus, it is acceptable to derive data on skin and eye irritation from the read across substance mSOFA.
Procedures and observations
The potential of the test item to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL of the test item to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals). 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application and in weekly intervals until day 14. The material caused slight to moderate corneal opacity, moderate iritis, slight to obvious conjunctival redness, slight to severe chemosis, slight to severe discharge and additional findings like small retraction in the eyelid, contracted pupil and injected scleral vessels in a circumscribed or circular area were noted in the animals during observation period. In two animals the ocular reactions were reversible within 14 days, in one animal within 21 days after application.
The potential of the test item to cause acute dermal irritation or corrosion was assessed by a single topical application of an amount of 0.5ml of the material for 4 hours to the intact skin of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and in weekly intervals until day 14. The substance caused very slight to moderate erythema, very slight to severe edema, scaling and a yellowish discoloration of the application site. The cutaneous reactions were not reversible in all animals within 14 days after removal of the patch.
Discussion
Considering the described ocular reactions as well as the average score for irritation, the test item shows a skin and an eye irritating potential under the test conditions chosen.
Justification for selection of skin irritation / corrosion endpoint:
key study, suitable read across substance
Justification for selection of eye irritation endpoint:
key study, suitable read across substance
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified as irritating for skin and eyes under Directive 67/548/EEC, as amended for the 30th time in Directive 2008/58/EC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for irritation under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).
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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