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Diss Factsheets
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EC number: 268-452-3 | CAS number: 68092-28-4
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Not skin sensitising
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Tall oil and diethanolamine (DEA) are the two primary metabolites of the target substance. This was confirmed with both the TIMES rat liver S9 metabolism model and the TIMES skin metabolism simulator. Therefore, the skin sensitization potential of the target substance should be fully satisified using these two source substances. For further information on the read across substances and metabolism of the target substance, see the Read Across Justification document in Section 13.
The potential of the read across substance distilled tall oil to cause skin sensitisation (delayed contact hypersensitivity) was investigated in a guinea-pig maximisation test conducted in accordance with the standardised guideline OECD 406 under GLP conditions. It was assigned a reliability score of 2 in accordance with the criteria detailed by Klimisch (1997).
Twenty albino Dunkin-Hartley guinea-pigs were exposed to the test material. The concentrations used in the induction phase of the study were 7.5 % v/v in Alembicol D for the intradermal application and undiluted test material for the topical application.
In the challenge application, the animals were exposed to the test material as supplied and 50 % v/v in Alembicol D.
No signs of ill health or toxicity were observed throughout the study. The test material elicited dermal reactions similar to those seen in the control animals.
Under the conditions of this study, the test material did not produce evidence of skin sensitisation and therefore requires no classification in accordance with EU criteria.
The potential of the second read across test material, diethanolamine, to cause skin sensitisation was also investigated in a guinea-pig maximisation test conducted in accordance with the standardised guideline OECD 406 under GLP conditions. It was assigned a reliability score of 2 in accordance with the criteria detailed by Klimisch (1997).
Twenty female Himalayan guinea-pigs were exposed to the test material. The concentrations used in the induction phase of the study were 5 % in saline and 5 % in saline/FCA for the intradermal and 25, 50, 75 and 100 % in physiological saline for the topical application.
In the challenge application, the animals were exposed to the test material at 25 % v/v in physiological saline.
No signs of ill health or toxicity were observed throughout the study. The test material elicited dermal reactions similar to those seen in the control animals.
Under the conditions of this study, the test material did not produce evidence of skin sensitisation and therefore requires no classification in accordance with EU criteria.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for skin or respiratory sensitisation.
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.
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