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EC number: 607-384-4 | CAS number: 244768-32-9
- 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
- Bacterial reverse mutation assay
In a K2 bacterial reverse mutation assay in Salmonella typhimurium strains TA1535, TA1537, TA102, TA98 and TA100, performed according to OECD Guideline 471 (Vanparys et al., 2004), it was concluded that T002488 has no mutagenic properties towards the Salmonella typhimurium strains tested in the absence and in the presence of Aroclor 1254 induced rat liver enzymes. This well-documented study is used as key study for in vitro gene mutation in bacteria.
- Chromosome aberration study
In a K2 in vitro chromosome aberration study in human lymphocytes, performed according to a method equivalent to OECD Guideline 473 (Wright, 2005), T002488 was considered to be non-clastogenic to human lymphocytes in vitro in the absence and presence of rat liver enzyme metabolising system.
- Gene mutation study in mammalian cells
In a K1 well-documented and GLP compliant mouse lymphoma assay, performed according to the OECD Guideline 490 (Verspeek-Rip, 2016), it was concluded that T002488 is not mutagenic in the mouse lymphoma L5178Y test system in the presence and absence of rat liver metabolic activation system under the experimental conditions described in the report.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Bacterial reverse mutation assay
A
key study (K2, Vanparys et al, 2004) was performed according to OECD
Guideline 471 (Bacterial Reverse Mutation Assay). Five strains of Salmonella
typhimurium, TA1535,
TA1537, TA102, TA98 and TA100, were treated with solutions of the test
item using the Ames plate incorporation method at 7 dose levels, in
triplicate, in the absence and in the presence of a rat liver metabolic
activation system. The dose range was 9.77 to 625 µg/plate in the main
experiment. DMSO was selected as vehicle.
In the absence and in the presence (20 and 50μl
S9 homogenate/plate) of a metabolic activation system, T002488 did not
cause any biologically significant increase in the number of revertant
colonies above the vehicle control incidence with all of the strains.
No toxic effects were observed. At concentrations of 39.07 or 78.13 or 156.25 onwards, a dose related increase in precipitation was observed. At the top dose level of 625μg/plate, no bacterial background could be observed due to heavy precipitation.
The vehicle (DMSO) and positive control counts of all strains fell within the required norms and the genotypes could be confirmed for all the strains validating the results from this study.
It can be concluded that T002488 has no mutagenic properties towards the various S. typhimurium strains under the test conditions.
Chromosome aberration:
Wright (K2, 2005) performed an in vitro chromosome aberration study in human lymphocytes (method equivalent/similar to OECD Guideline 473: In Vitro Mammalian Chromosome Aberration Test). The test item, dissolved in ethanol, was assessed for its potential to induce chromosomal aberrations in human lymphocytes in vitro in the absence and the presence of metabolic activation by S9 mix.
Duplicate cultures of human lymphocytes were exposed to a series of concentrations of the test item, ranging from 18.03 to 576.75 µg/mL. A minimum of three concentration levels and the concurrent vehicle and positive controls were evaluated for chromosome aberrations for each exposure group. Except where there was the need to clarify an equivocal response only one of the duplicate cultures was assessed for the presence chromosome aberrations. Two independent experiments were performed. In the first experiment (Groups 1 and 2) the exposure periods were 4 hours with and without S9 mix, with a 20 hour recovery period. In the second experiment the exposure period was 24 hours without S9 mix. 100 metaphases were scored per concentration for the chromosome aberrations.
The data for the 4-hour exposure groups show some modest reductions in mitotic index but no clear dose-response relationship. They were therefore considered not to be toxicity-related. In all exposures there were scorable metaphases cells up to 576.75 μg/ml but solubility was used as the criteria for the selection of the upper dose level for analysis.
All of the vehicle control cultures had frequencies of cells with chromosome aberrations within the expected range. The positive control materials induced statistically significant increases in the frequency of cells with aberrations. It was therefore considered that the metabolic activation system was shown to be functional and the test method itself was operating as expected.
The test material did not
induce statistically significant increases in the frequency of cells
with aberrations in any of the exposure groups.
The test material did not induce a statistically significant increase in
the numbers of polyploid cells in any of the exposure groups.
In conclusion, T002488 is considered to be non-clastogenic to human lymphocytes in vitro.
In vitro gene mutation study in mammalian cells:
Verspeek - Rip (K1, 2016)
investigated the mutagenic activity of the test item in an in
vitro mammalian cell gene mutation test with L5178Y mouse lymphoma
cells according to the OECD Guideline 490 (In Vitro Mammalian Cell Gene
Mutation Tests Using the Thymidine Kinase Gene).
The test item, dissolved in dimethyl sulfoxide, was assessed for its
potential to induce forward mutations at the thymidine-kinase locus
(TK-locus) in L5178Y mouse lymphoma cells. The test was performed in the
presence of S9-mix with a 3-hour treatment period and in the absence of
S9-mix with a 3 and 24-hour treatment period.
In the first mutation experiment, the test item was tested up to
concentrations of 52 μg/ml in the absence and presence of S9-mix. The
treatment period was 3 hours. No toxicity was observed up to the
concentration of 52 μg/ml in the absence and presence of S9-mix. The
test item precipitated in the culture medium at the concentrations of 26
μg/ml and onwards.
In the second mutation experiment, the test item was tested up to
concentrations of 20 μg/ml in the absence of S9-mix. The treatment
period was 24 hours. No significant toxicity was observed up to the
concentration of 20 μg/ml. The test item precipitated in the culture
medium at the concentration of 20 μg/ml.
The mutation frequency found in the solvent control cultures was within the acceptability criteria of this assay and within the 95% control limits of the distribution of the historical solvent control database. Positive control chemicals, methyl methanesulfonate and cyclophosphamide, both produced significant increases in the mutation frequency. In addition, the mutation frequency found in the positive control cultures was within the 95% control limits of the distribution of the historical positive control database. It was therefore concluded that the test conditions were adequate and that the metabolic activation system (S9-mix) functioned properly.
In the absence of S9-mix,
the test item did not induce a significant increase in the mutation
frequency after a 3-hour treatment period. This result was confirmed in
an independent experiment with a treatment duration of 24 hours.
In the presence of S9-mix, the test item did not induce a significant
increase in the mutation frequency.
It is concluded that the test item is not mutagenic in the mouse
lymphoma L5178Y test system under the experimental conditions described
in this report.
Justification for classification or non-classification
Based on negative results in all available in vitro genetic toxicity tests with T002488 and the criteria of the CLP Regulation (EC) 1272/2008, the test item should not be classified for mutagenicity.
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