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EC number: 434-230-1 | CAS number: 144413-22-9
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- This study was conducted according to Safepharm Standard Method 700.03 and was designed to assess the mutagenic potential of the test material using a bacterial/microsome test system. The study was based on the in vitro technique described by Ames and Garner et al.
The method conforms to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including MITI, MHW, MOL and MAFF. It also meets the requirements of the OECD, EC and USA, EPA (TSCA) guidelines. - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 434-230-1
- EC Name:
- -
- Cas Number:
- 144413-22-9
- Molecular formula:
- Not applicable - the substance is an UVCB
- IUPAC Name:
- 1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylic acid; prop-2-enoic acid
- Test material form:
- other: pale yellow blocks
- Details on test material:
- - Chemical name: Rosin acid reaction products with acrylic acid hydrogenated
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- - Preliminary Toxicity Test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
- Main test, experiment I and II: 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- Dimethyl sulphoxide
Controls
- Untreated negative controls:
- other: Solvent control served as negative control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- 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:
- The Salmonella strains were obtained from the University of California at Berkeley on culture discs on 4 August 1995 whilst the Escherichia coli strain
WP2uvrA- was obtained from the British Industrial Biological Research Association on 17 August 1987. All of the strains were stored at -196°C in a
Statebourne liquid nitrogen freezer, model SXR 34. 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 spontaneous reversion rate.
In this assay, overnight sub-cultures of the appropriate coded stock cultures were prepared in nutrient broth (Oxoid Limited; lot numbers 201416 1/03 and 201417 1/03) and incubated at 37°C for approximately 10 hours. - Evaluation criteria:
- ACCEPTANCE 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 10E9 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 minimum of four non-toxic test material dose levels. There should be no evidence of excessive contamination.
EVALUATION CRITERIA:
The test material may be considered positive in this test system if the following criteria are met:
The test material should have induced a reproducible, dose-related and statistically (Dunnett's method of linear regression) significant increase in the revertant count in at least one strain of bacteria. If a greater than twofold increase in revertant count is observed in two experiments then this is taken as evidence of a positive response. - Statistics:
- Dunnett's method of linear regression
Results and discussion
Test resultsopen allclose all
- Key result
- 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:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- VEHICLE CONTROL
The results for the negative control (solvent control plates) were considered to be acceptable .
POSITIVE CONTROL
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
TEST MATERIAL
No toxicity was exhibited to any of the strains of bacteria used. A precipitate was observed at 5000 µg/plate, this did not prevent the scoring of revertant colonies. No significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria, at any dose level either with or without metabolic activation.
Any other information on results incl. tables
PRELIMINARY TOXICICTY STUDY
The test material was non-toxic to the strains of bacteria used (TA 100 and WP2uvrA).
No. of revertant colonies per dose [µg/plate]
S9 -mix |
strain |
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
+ |
TA100 |
134 |
127 |
126 |
103 |
102 |
111 |
113 |
105 |
91 |
79 |
96* |
- |
TA100 |
116 |
111 |
114 |
95 |
146 |
120 |
93 |
108 |
84 |
84 |
83* |
+ |
WP2uvrA |
27 |
24 |
26 |
24 |
25 |
32 |
37 |
28 |
28 |
28 |
34* |
- |
WP2uvrA |
29 |
18 |
28 |
25 |
22 |
17 |
35 |
20 |
15 |
20 |
21* |
* Precipitation
MAIN STUDY
EXPERIMENT I - Mean no. of revertant colonies
S9 -mix | test item [µg/plate] | TA100 | TA1535 | WP2uvrA | TA98 | TA1537 |
- | 0 | 124 | 20 | 27 | 26 | 12 |
- | 50 | 109 | 20 | 31 | 30 | 9 |
- | 150 | 114 | 25 | 22 | 27 | 6 |
- | 500 | 98 | 10 | 24 | 30 | 9 |
- | 1500 | 101 | 17 | 22 | 18 | 12 |
- | 5000 | 103 | 17 | 23 | 20 | 6 |
- | pos. control | 440 | 250 | 683 | 140 | 1018 |
+ | 0 | 114 | 17 | 32 | 32 | 15 |
+ | 50 | 104 | 15 | 26 | 33 | 12 |
+ | 150 | 99 | 15 | 35 | 35 | 15 |
+ | 500 | 99 | 14 | 20 | 33 | 11 |
+ | 1500 | 83 | 12 | 27 | 31 | 9 |
+ | 5000 | 76 | 11 | 19 | 22 | 6 |
+ | pos. control | 791 | 198 | 706 | 510 | 223 |
EXPERIMENT II - mean no. of revertant colonies
S9 -mix | test item [µg/plate] | TA100 | TA1535 | WP2uvrA | TA98 | TA1537 |
- | 0 | 135 | 31 | 25 | 34 | 17 |
- | 50 | 119 | 29 | 23 | 32 | 13 |
- | 150 | 129 | 22 | 20 | 27 | 6 |
- | 500 | 118 | 20 | 18 | 25 | 7 |
- | 1500 | 99 | 23 | 21 | 31 | 6 |
- | 5000 | 106 | 21 | 27 | 36 | 11 |
- | pos. control | 631 | 165 | 486 | 136 | 1001 |
+ | 0 | 128 | 13 | 26 | 34 | 19 |
+ | 50 | 127 | 18 | 27 | 41 | 14 |
+ | 150 | 123 | 16 | 25 | 34 | 14 |
+ | 500 | 120 | 14 | 30 | 36 | 9 |
+ | 1500 | 113 | 13 | 26 | 27 | 10 |
+ | 5000 | 111 | 14 | 27 | 41 | 6 |
+ | pos. control | 959 | 252 | 1184 | 583 | 492 |
Applicant's summary and conclusion
- Conclusions:
- The test material was considered to be non-mutagenic under the conditions of this test.
- Executive summary:
Salmonella typhimurium strains TA1535, TA1537, TA98, 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). This method conforms to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including MITI, MHW, MOL and MAFF. It also meets the requirements of the OECD, EC and USA, EPA (TSCA) guidelines. The dose range was determined in a preliminary toxicity assay and was 50 to 5000 µg/plate in the first experiment. The experiment was repeated on a separate day using the same dose range as Experiment 1, 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 controI chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and 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 lawn at any dose level. The test material was, therefore, tested up to the maximum recommended dose of 5000 µg/plate. A precipitate was observed at 5000 pg/plate, this did not prevent the scoring of revertant colonies.
No significant increases in the frequeney 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.
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