Registration Dossier
Registration Dossier
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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In vitro mutagenicity has been studied for two or more of the FLL Substances tested using a combination of three tests. Briefly, the results of the mutagenicity tests include :
- In vitro gene mutation study in bacteria (FLL Samples 2, 3, 4 and 6) – not mutagenic in bacteria (AMES test with S. typhirium and E. coli)
- In vitro cytogenicity study in mammalian cells (FLL Samples 3 and 4) – not clastogenic in human lymphocytes
- In vitro gene mutation study in mammalian cells (FLL Samples 3 and 4) - not mutagenic to L5178Y cells
These studies provide consistent results indicating a general lack of mutagenicity potential for the FLL Substances. A further line of evidence is that decision-tree modelling according to the Begnini-Boss Rulebase (ToxTree v.1.6; IdeaConsult) did not identify any alert for mutagenicity for a fish oil derivative and a vegetable oil derivative representing the FLL Substances .
Thus, the weight of evidence provided by the in vitro data indicates that the FLL Substances should not be classified as germ cell mutagens.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
- In vitro gene mutation study in bacteria (FLL Samples 2, 3, 4 and 6) – not mutagenic in bacteria (AMES test with S. typhirium and E. coli)
- In vitro cytogenicity study in mammalian cells (FLL Samples 3 and 4) – not clastogenic in human lymphocytes
- In vitro gene mutation study in mammalian cells (FLL Samples 3 and 4) - not mutagenic to L5178Y cells
In vitro mutagenicity has been studied for two or more of the FLL Substances tested using a combination of three tests. Briefly, the results of the mutagenicity tests include :
These studies provide consistent results indicating a general lack of mutagenicity potential for the FLL Substances. A further line of evidence is that decision-tree modelling according to the Begnini-Boss Rulebase (ToxTree v.1.6; IdeaConsult) did not identify any alert for mutagenicity for a fish oil derivative and a vegetable oil derivative representing the FLL Substances . Thus, the weight of evidence provided by the in vitro data indicates that the FLL Substances should not be classified as germ cell mutagens.
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