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Diss Factsheets
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EC number: 944-405-9 | CAS number: -
- 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
Ames test:
The mutagenic activity of the substance IFF TM FRET 13 -0156 was evaluated in accordance with OECD 471 (1997) and according to GLP principles. The test was performed in two independent experiments, both in the absence and presence of S9-mix. The dose levels were selected based on observed cytotoxicity in all strains, except in strain WP2uvrA. Adequate negative and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in strain WP2uvrA , both in the absence and presence of S9-metabolic activation. These results were confirmed in independently repeated experiments. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Micronucleu assay:
In a micronucleus assay, cultured peripheral human lymphocytes were exposed to different concentrations of the substance (dissolved in DMSO), in the presence and absence of S9-mix according to OECD 487 guideline and GLP principles.
The percentage of cells with micronuclei in the test article-treated group was not significantly increased relative to vehicle control at any dose level (p > 0.05, Fisher's Exact test) in the S9-activated 4-hour exposure group or the non-activated 24-hour exposure group. statistically increased but no dose-response relationship in three differetn treatment conditions.The percentage of cells with micronucleated binucleated cells in the non-activated 4-hour exposure group was statistically significantly increased relative to vehicle control at 800 μg/mL (p ≤ 0.05, Fisher’s Exact test) (the highest dose analyzed for mucronucleus was 1200 ug/ml). However, the Cochran-armitage test was negative for a dose response. In addition, the percentage of micronucleated binucleated cells in the test article-treated group (0.4%) was within the historical solvent control range of 0.1% to 1.6%. Therefore, the statistically significant increase was not considered to be biologically relevant.
The results for the positive and vehicle controls indicate that all criteria for a valid assay were met. Based on these criteria, the results are justified and do not require a repeat of any portions of the study.
Therefore FRET 13-0156 was concluded to be negative for the induction of micronuclei in the non-activated and S9-activated test systems in the in vitro mammalian micronucleus test using human peripheral blood lymphocytes.
Justification for selection of genetic toxicity endpoint
The results of the bacterial and micronucleus assays are reliable
and adequate for covering this endpoint.
Short description of key information:
Ames test (OECD TG 471): negative
In vitro chromosome aberration test (OECD TG 487): negative
Endpoint Conclusion:No adverse effect observed (negative)
Justification for classification or non-classification
Based on the results of the genotixicity assays, IFF TM 13 -0156 does not have to be classified for genotoxicity in accordance with Regulation (EC) No. 1272/2008.
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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