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Diss Factsheets
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EC number: 272-789-1 | CAS number: 68911-83-1
- 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 corrosion / irritation:
No reliable study is available for the skin irritation endpoint. Based on the reliable data for the eye irritation tests, no additional skin irritation should be performed and a waiver based on expert judgement is added to this dossier.
Gabriel (1974) performed an in vivo skin and in vivo eye irritation test in New Zealand White rabbits. Skin and eye irritation was observed in this old study that had some deficiencies. A new in vitro and in vivo eye irritation test has been performed with this substance. The latter tests didn't reveal eye irritation. As the eye is generally more vulnerable for irritation/corrosion, it is considered unnecessary to perform a new in vivo skin irritation test and it is considered that the substance should not be classified for irritation to the skin.
Eye corrosion / irritation:
Two K1 studies are available for this endpoint (one in vitro and one in vivo study). The in vivo test is selected as key study as in vivo studies are more reliable than in vitro studies. Based on the outcome of the study, the substance do not need to be classified for eye irritation.
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
Skin irritation / corrosion:
No study need to be performed for this endpoint. Therefore following waiver statement is added to the dossier based on the data of the reliable eye irritation tests and expert judgement:
Gabriel (1974) performed an in vivo skin and in vivo eye irritation test in New Zealand White rabbits (K3 study). Skin and eye irritation was observed in this old study that had some deficiencies. A new in vitro and in vivo eye irritation test has been performed with this substance. The latter tests didn't reveal eye irritation. As the eye is generally more vulnerable for irritation/corrosion, it is considered unnecessary to perform a new in vivo skin irritation test and it is considered that the substance should not be classified for irritation to the skin.
Eye irritation:
An in vivo study was performed in New Zealand White rabbits (Stitzinger, 2013). Based on the results of this test, reaction product of oleic acid, N1-(9Z)-9-octadecen-1-yl-1,3-propanediamine and paraformaldehyde does not have to be classified and has no obligatory labelling requirements for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and Regulation (EC) No 1272/2008 of the European Parliament and the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures including all amendments.
In addition, a reliable in vitro study was performed with corneas of bovine eyes from young cattle (Verspeek-Rip, 2013). The purpose of this study was to determine the eye irritation potential of the test material after a treatment period of 10 minutes. The Reaction Product of Oleic acid, N1-(9Z)-9-octadecen-1 -yl-1,3 -propanediamine and paraformaldehyde is not severe irritant or corrosive in the bovine corneal opacity and permeability test under the experimental conditions of this test.
A non reliable K3 study (Gabriel, 1974) observed conjunctival redness and chemosis but no final conclusion could be made related to classification based on the available data and criteria of the CLP Regulation. In addition, observations were stopped 7 days after the exposure period. No conclusion could be made on overall reversibility of effects and therefore, an in vitro and in vivo eye irritation test were performed which revealed no eye irritation (Verspeek-Rip, 2013; Stitzinger, 2013, respectively).
Justification for selection of skin irritation / corrosion endpoint:
Study waived
Justification for selection of eye irritation endpoint:
In vivo test is more reliable than an in vitro test
Justification for classification or non-classification
Based on the available data and according to DSD/CLP criteria, the substance should not be classified for skin irritation / corrosion nor eye irritation / corrosion.
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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