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EC number: 701-057-0 | CAS number: 2156595-41-2
- 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
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in a GLP facility according to OECD guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- The Salmonella typhimurium strains were obtained from the University of California at Berkele in culture discs on 4 August 1995 whilst Escherichia coli strain WP2uvrA" was obtained from the British Industrial Biological Research Association on 17 August 1987. All of the strains were
stored at -196C. Prior to the master strains being used, characterisation checks were carried out to confirm the amino-acid requirement, presence of rfa, R factors, uvrB or uvrA mutation and the sontaneous reversion rate. - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- The Salmonella typhimurium strains were obtained from the University of California at Berkele in culture discs on 4 August 1995 whilst Escherichia coli strain WP2uvrA" was obtained from the British Industrial Biological Research Association on 17 August 1987. All of the strains were
stored at -196C. Prior to the master strains being used, characterisation checks
were carried out to confirm the amino-acid requirement, presence of rfa, R factors, uvrB or uvrA mutation and the sontaneous reversion rate. - Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver (induced) S9
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500 and 5000 ug/plate
- Vehicle / solvent:
- Dimethyl sulfoxide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- Preliminary Toxicity Test
In order to select appropriate dose levels for use in the main test, a preliminary assay was
carried out to determine the toxicity of the test material. The concentrations tested were 0,
0.15, 0.5, 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 ug/plate. The assay was performed by mixing 0.1 ml of
bacterial culture (TA100 or WP2uvrA), 0.1 ml of test material formulation, 0.5 ml of S9-mix or
phosphate buffer and 2 ml of molten, trace histidine or tryptophan supplemented, top agar and
overlaying onto sterile plates of Vogel-Bonner Minimal agar (30 ml/plate). Ten concentrations
of the test material and a vehicle control (dimethyl sulphoxide) were tested. In addition, 0.1 ml
of the maximum concentration of the test material and 2 ml of molten, trace histidine or tryptophan
supplemented, top agar was overlaid onto a sterile Nutrient agar plate in order to
assess the sterility of the test material. After approximately 48 hours incubation at 37°C
the plates were assessed for numbers of revertant colonies using a Domino colony counter
and examined for effects on the growth of the bacterial bacterial background lawn.
Mutation Test- Experiment 1 (Range-finding Test)
Five concentrations of the test material (50, 150, 500, 1500 and 5000 ug/plate) were assayed in
triplicate against each tester strain, using the direct plate incorporation method.
Measured aliquots (0.1 ml) of one of the bacterial cultures were dispensed into sets of test
tubes followed by 2.0 ml of molten, trace histidine or tryptophan supplemented, top agar, 0.1 ml
of the test material formulation, vehicle or positive control and either 0.5 ml of S9-mix or
phosphat buffer. The contents of each test tube were mixed and equally distributed onto
the surface of Vogel-Bonner Minimal agar plates (one tube per plate). This procedure
was repeated, in triplicate, for each bacterial strain and for each concentration of test
material both with and without S9-mix.
All of the plates were incubated at 37°C for approximately 48 hours and the frequency of revertant
colonies assessed using a Domino colony counter.
Mutation Test-Experiment 2 (Main Test)
The second experiment was performed using methodology as described for the range-finding test
using fresh bacterial cultures, test material and control solutions. The test material dose range
was the same as the range-finding test (50 to 5000 ug/plate). - Evaluation criteria:
- The reverse mutation assay may be considered valid if the following criteria are met:
All tester strain cultures exhibit a characteristic number of spontaneous revertants per plate
in the vehicle and untreated controls.
The appropriate characteristics for each tester strain have been confirmed, eg rfa
cell-wall mutation and pKM101 plasmid R-factor etc.
All tester strain cultures should be in the approximate range of 1 to 9.9 x 10^9 bacteria per ml.
Each mean positive control value should be at least two times the respective vehicle control value
for each strain, thus demonstrating both the intrinsic sensitivity of the tester strains to mutagenic exposure
and the integrity of the S9 mix
There should be a minumum of 4 non-toxic test material dose levels
There should not be an excessive loss of plates due to contamination. - Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- The test material was considered to be non-mutagenic under the conditions of this test.
- Executive summary:
Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were treated with the test material using the Ames plate incorporation method at five dose levels, in triplicate, both with and without the addition of a
rat liver homogenate metabolising system (10% liver S9 in standard co-factors). The dose range for the range-finding test was determined in a preliminary toxicity assay and was 50 to 5000 ug/plate. The experiment was repeated on a separate day using the same dose range as the range-finding test, fresh cultures of the bacterial strains and fresh test material formulations.
The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic
activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material was, therefore, tested up to the maximum recommended dose level of 5000 ug/plate. A greasy film was observed at and above 1500 ug/plate, this did not prevent the scoring of revertant colonies. No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.
The test material was considered to be non-mutagenic under the conditions of this test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Ames Assay:
Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were treated with the test material using the Ames plate incorporation method at five dose levels, in triplicate, both with and without the addition of a
rat liver homogenate metabolising system (10% liver S9 in standard co-factors). The dose range for the range-finding test was determined in a preliminary toxicity assay and was 50 to 5000 ug/plate. The experiment was repeated on a separate day using the same dose range as the range-finding test, fresh cultures of the bacterial strains and fresh test material formulations.The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material was, therefore, tested up to the maximum recommended dose level of 5000 ug/plate. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation. The test material was considered to be non-mutagenic under the conditions of this test.
In vitro Chromosomal Aberration:
This report describes the results of an in vitro study for the detection of structural chromosomal aberrations in cultured mammalian cells. Duplicate cultures of human lymphocytes, treated with the test item, were evaluated for chromosome aberrations at up to four dose levels, together with vehicle and positive controls. Four treatment conditions were used for the study, i.e. In Experiment 1, 4 hours in the presence of an induced rat liver homogenate metabolising system (S9), at a 2% final concentration with cell harvest after a 20-hour expression period and a 4 hours exposure in the absence of metabolic activation (S9) with a 20-hour expression period. In Experiment 2, the 4 hours exposure with addition of S9 was repeated (using a 1% final S9 concentration); whilst in the absence of metabolic activation the exposure time was increased to 24 hours. The dose levels used in the main experiments were selected using data from the preliminary toxicity test and were as follows:
Group Final concentration of test item (μg/ml)
4(20)-hour without S9: 8, 16, 24, 32, 48, 64
4(20)-hour with S9 (2%): 8, 16, 24, 32, 48, 64
24-hour without S9: 4, 8, 16, 24, 32, 48
4(20)-hour with S9 (1%): 8, 16, 24, 32, 48, 64
The test item did not induce any statistically significant increases in the frequency of cells with aberrations in the exposure groups dosed in the presence or absence of S9, which included a dose level that was generally within the optimal 50% mitotic inhibition. The test item, Technical Hydroabietyl Alcohol, was considered not to induce any statistically significant increases in the frequency of cells with aberrations and, therefore was considered to be non-clastogenic.
In vitro Mammaliam Mutagenicity
The study was conducted according to a method that was designed to assess the potential mutagenicity of the test item on the thymidine kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line. Two independent experiments were performed. In Experiment 1, L5178Y TK +/- 3.7.2c mouse lymphoma cells (heterozygous at the thymidine kinase locus) were treated with the test item at eight dose levels, in duplicate, together with vehicle (solvent) and positive controls using 4-hour exposure groups both in the absence and presence of metabolic activation (2% 89 final concentration). In Experiment 2, the cells were treated with the test item at eight dose levels using a 4 -hour exposure group in the presence of metabolic activation (2% S9 final concentration) and a 24-hour exposure group in the absence of metabolic activation. The dose range of test item was selected following the results of a preliminary toxicity test and was 1.25 to 50 ug/ml in the absence of metabolic activation, and 3.13 to 100 ug/ml in the presence of metabolic activation for Experiment 1. In Experiment 2 the dose range was 1.25 to 50 ug/ml in the absence of metabolic activation, and 10 to 80 ug/ml in the presence of metabolic activation. The maximum dose levels used in the Mutagenicity Test were limited by test item-induced toxicity. Precipitate of test item was not observed at any of the dose levels in the Mutagenicity Test. The vehicle (solvent) controls had mutant frequency values that were considered acceptable for the L5178Y cell line at the TK +/- locus. The positive control items induced marked increases in the mutant frequency indicating the satisfactory performance of the test and of the activity of the metabolising system.The test item did not induce any reproducible toxicologically significant dose-related increases in the mutant frequency at any dose level, either with or without metabolic activation, in either the first or second experiment. The test item was considered to be non-mutagenic to L5178Y cells under the conditions of the test.
Justification for selection of genetic toxicity endpoint
Negative effects were found in all 3 studies, but only one "endpoint selection" is allowed
Justification for classification or non-classification
As only negative effects were observed, no classification is justified
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