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EC number: - | 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
Genetic toxicity in vitro
Description of key information
Not mutagenic
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro gene mutation in bacteria (Ames)
The mutagenic effect of the test item was assessed according to the method descibed in the OECD guideline 471.A preliminary toxicity test was performed to define the dose levels of the test item, dissolved in water for injections, to be used for the mutagenicity experiments. The test item was then tested in two independent experiments, both with and without a metabolic activation system, the S9 mix, prepared from a liver post-mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
Treatments were performed according to the direct plate incorporation method, except for the second experiment with S9 mix, which was performed according to the pre-incubation method (60 minutes, 37°C).
Four strains of bacteria Salmonella typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and one strain of Escherichia coli (WP2 uvrA) were used. Each strain was exposed to at least five dose levels of the test item (three plates/dose level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored.
The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
The test item was freely dissolved in the vehicle (water for injections) at 50 mg/mL, after a minimum of 30 minutes of magnetic stirring. Since the test item was toxic in the preliminary test, the selection of the highest dose level to be used in the main experiments was based on the level of toxicity, according to the criteria specified in the international guidelines.
The mean number of revertants for the vehicle and positive controls met the acceptance criteria. Also, there were at least five analysable dose levels (i.e.including at least three non-cytotoxic dose levels) for each strain and test condition. The study was therefore considered to be valid.
Experiments without S9 mix
The selected dose levels were:
- 2.06, 6.17, 18.5, 55.6, 167 and 500µg/plate for the TA 1535 and TA 100 strains in the first experiment,
- 0.686, 2.06, 6.17, 18.5, 55.6 and 167µg/plate for the TA 1537 and TA 98 strains in the first experiment,
- 6.25, 12.5, 25, 50, 100 and 200 µg/plate for the TA 100 strain in the second experiment,
- 3.13, 6.25, 12.5, 25, 50 and 100µg/plate for the TA 1535, TA 1537 and TA 98 strains in the second experiment,
- 312.5, 625, 1250, 2500 and 5000 µg/plate for the WP2 uvrA strain in both experiments.
No precipitate was observed in the Petri plates when scoring the revertants at any of the tested dose levels.
A strong toxicity was noted at dose levels >= 50 µg/plate in the TA 1537 and TA 98 strains, >= 55.6 µg/plate in the TA 1535 strain and >= 167 µg/plate in the TA 100 strain.
No noteworthy toxicity was noted in the WP2 uvrA strainat any of the tested dose levels.
The test item did not induce any noteworthy increase in the number of revertants, in any of the five tested strains, in either experiment. These results met the criteria of a negative response.
Experiments with S9 mix
The selected dose levels were:
- 2.06, 6.17, 18.5, 55.6, 167 and 500µg/plate for the TA 1535 and TA 100 strains in the first experiment,
- 0.686, 2.06, 6.17, 18.5, 55.6 and 167µg/plate for the TA 1537 and TA 98 strains in the first experiment,
- 2.57, 7.72, 23.1, 69.4, 208 and 625µg/plate for the TA1535, TA1537, TA 98 and TA 100 strains in the second experiment,
- 312.5, 625, 1250, 2500 and 5000 µg/plate for the WP2 uvrA strain in both experiments.
No precipitate was observed in the Petri plates when scoring the revertants at any of the tested dose levels.
A strong toxicity was noted at dose levels >= 69.4 µg/plate in the TA 1537 strain, >= 167 µg/plate in the TA 98 strain, >= 208 µg/plate in the TA 1535 strain and >= 500 µg/plate in the TA 100 strain.
No noteworthy toxicity was noted in the WP2 uvrA strainat any of the tested dose levels.
The test item did not induce any noteworthy increase in the number of revertants, in any of the five tested strains, in either experiment. These results met the criteria of a negative response.
Under the experimental conditions of this study, the test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli strains, either in the presence or absence of a rat liver metabolizing system.
Justification for classification or non-classification
GERM CELL MUTAGENICITY
This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class.
Category 1: Substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. Substances known to induce heritable mutations in the germ cells of humans.
Categoty 2: Substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.
Classification for heritable effects in human germ cells is made on the basis of well conducted, sufficiently validated tests as In vitro mutagenicity tests such as these indicated in 3.5.2.3.8:
- in vitro mammalian chromosome aberration test;
- in vitro mammalian cell gene mutation test;
- bacterial reverse mutation tests
The substance to be registered shows negative results on the strains of Salmonella typhimurium and E. Coli under the performed test, therefore data available are conclusive but not sufficient for the classification, according to the 3.5. of the CLP Regulation n.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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