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Diss Factsheets
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EC number: 307-037-4 | CAS number: 97488-98-7
- 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
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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:
- Migrated from Short description of key information:
Skin sensitization in vivo was tested using the local lymph node assay in the mouse for FLL Samples 3 and 4. According to the test results, both samples would be considered weak sensitizers with a Stimulation Index (SI) > 3 at 50% and 100% test concentrations. However, based on the following discussion, it is expected that these results were likely to have been “false-positives”.
Briefly, FLL Samples 3 and 4 produced maximum SI values of 4.81 and 3.85, respectively. While these are both ≥ 3 and could warrant a label of skin sensitization, guidance from OECD (2002) and EC (2008) state that a weight-of-evidence approach is warranted. The fatty acid components of FLL Samples 3 and 4 are naturally occurring compounds, and linoleic acid is an essential human fatty acid (Burr et al. 1932). FLL Sample 4 showed a weak dose-response relationship, where the 100% concentration produced less of a response than the 50% concentration. Several of the raw (unreacted) oils for both of these compounds have been shown to produce a positive result with LLNA and a negative result with GPMT (Kreiling et al. 2008). Given the addition of a sulfonate group is not a chemical predictor for skin sensitization (Barratt et al. 1994), the false positive findings of the oils tested by Kreiling et al. (2008) are applicable to the sulfonated components of the FLL Substances.
Therefore, the weakly positive responses for these tests should not result in a classification as a skin sensitizer for the FLL Substances.
Justification for classification or non-classification
Skin sensitizationin vivowas tested using the local lymph node assay in the mouse for FLL Samples 3 and 4. According to the test results, both samples would be considered weak sensitizers with a Stimulation Index (SI) > 3 at 50% and 100% test concentrations. However, based on the following discussion, it is expected that these results were likely to have been “false-positives”.
Briefly, FLL Samples 3 and 4 produced maximum SI values of 4.81 and 3.85, respectively. While these are both≥3 and could warrant a label of skin sensitization, guidance from OECD (2002) and EC (2008) state that a weight-of-evidence approach is warranted. The fatty acid components of FLL Samples 3 and 4 are naturally occurring compounds, and linoleic acid is an essential human fatty acid (Burret al. 1932). FLL Sample 4 showed a weak dose-response relationship, where the 100% concentration produced less of a response than the 50% concentration. Several of the raw (unreacted) oils for both of these compounds have been shown to produce a positive result with LLNA and a negative result with GPMT (Kreilinget al.2008). Given the addition of a sulfonate group is not a chemical predictor for skin sensitization (Barrattet al.1994), the false positive findings of the oils tested by Kreilinget al.(2008) are applicable to the sulfonated components of the FLL Substances.
Therefore, the weakly positive responses for these tests should not result in a classification as a skin sensitizer for the FLL Substances.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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