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Diss Factsheets
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EC number: 288-003-5 | CAS number: 85631-54-5
- 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
Key value for chemical safety assessment
Additional information
The data set for the test substance genetic toxicity is robust and provides a thorough evaluation of in vitro gene mutations and clastogenicity/aneugenicity.
The mutagenic effects of the test item were determined in a reverse mutation assay with Salmonella typhimurium. The test was performed in the four salmonella typhimurium tester strains TA98, TA100, TA1535, TA1537 and in E. coli WP2 uvrA in concentrations from 100 to 5000 µL/plate with (+) and without (-) metabolic activation system. Result: not mutagen.
The potential of the test item to induce chromosome aberrations was investigated in human peripheral blood lymphocytes in vitro. For each experiment duplicate cell cultures were used for each concentration. The test compound was tested at concentrations of 125 to 3000 µg/mL including solvent controls with (+) and without (-) metabolic activation system from Aroclor induced Spraque Dawley-rat liver. Result: not clastogenic.
The test item Fluowet AC812 solid was assessed for its potential to induce gene mutations at the HPRT locus using V79 cells of the Chinese hamster. The study was performed in two independent experiments, using identical experimental procedures and concentrations of 312.5 up to 5000 µg/mL. In the first experiment the treatment period was 4 hours with and without metabolic activation. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. No relevant and reproducible increase in mutant colony numbers/106cells was observed in the main experiments up to the maximum concentration with and without metabolic activation. The induction factor did not reach or exceed the threshold of 3 times the mutation frequency of the corresponding solvent control. The mutation frequency did not exceed the historical range of solvent controls. In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells.
Result: non-mutagenic.
Therefore, the overall conclusion, based on the results from the robust data set, is that there is no genotoxic concern associated with the test material.
Short description of key
information:
The test item was tested for its genetic toxicity potential in three
in vitro testing systems (i.e. Ames test , Chromosome Aberration test
and HPRT test).
1. The Ames-test was performed with test item in the four salmonella
typhimurium tester strains TA98, TA100, TA1535, TA1537 and in E. coli
WP2uvrA in concentrations from 100 to 5000 µL/plate with (+) and without
(-) metabolic activation system. Result: negative.
2. The potential of the test item to induce chromosome aberrations was
investigated in human peripheral blood lymphocytes in vitro. For each
experiment duplicate cell cultures were used for each concentration. The
test compound was tested at concentrations of 125 to 3000µg/mL including
solvent controls with (+) and without (-) metabolic activation system
from Aroclor induced Spraque Dawley-rat liver. Result: the test item is
not clastogenic in this test system.
3. The test item was assessed for its potential to induce gene mutations
at the HPRT locus using V79 cells of the Chinese hamster. The study was
performed in two independent experiments, using identical experimental
procedures. In the first experiment the treatment period was 4 hours
with and without metabolic activation. The second experiment was
performed with a treatment time of 4 hours with and 24 hours without
metabolic activation. In conclusion it can be stated that under the
experimental conditions reported the test item did not induce gene
mutations at the HPRT locus in V79 cells. Therefore, the test item is
considered to be non-mutagenic in this HPRT assay.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The test item was examined for its mutagenic/genotoxic potential in three independent in vitro test systems, i.e. Ames test, Chromosome aberration test and HPRT test. Result: all three tests are negative under the test conditions described.
According to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council, 16 December 2008 (CLP or GHS Global Harmonized System for classification, labeling and packaging) Annex 1, the test substance has not to be classified.
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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