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EC number: 700-878-1 | CAS number: 1395069-30-3
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Feb 2012 - 02 Mar 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted according to GLP (2-AA was the only positive control used with metabolic activation).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- yes
- Remarks:
- 2-AA was the only positive control used for metabolic activation
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- GSID 3056-1
- IUPAC Name:
- GSID 3056-1
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): GSID 3056-1
- Physical state: solid, brownish
- Analytical purity: 98% (Analytical Report 11L00523)
- Lot/batch No.: 1470 VB04
- Storage condition of test material: room temperature
- Storage stability: The stability of the test substance under storage conditions throughout the study period was guaranteed until 06 Oct 2013 (as indicated by the sponsor, and the sponsor holds this responsibility).
Constituent 1
Method
- Target gene:
- his operon for S. typhimurium strains
trp operon for the E. coli strain
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: TA 98: rfa-, uvrB-, R-factor; TA 100: rfa-, uvrB-, R-factor; TA 1535: rfa-, uvrB-; TA 1537: rfa-, uvrB; WP2: trp-; uvr A-
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver mix prepared from Wistar rats treated with 80 mg/kg bw phenobarbital i.p. and β-naphthoflavone orally each on three consecutive days.
- Test concentrations with justification for top dose:
- First experiment (standard plate test, with and without metabolic activation, triplicate): 0, 33, 100, 333, 1000, 2500 and 5000 µg/plate
Second experiment (preincubation test with and without metabolic activation, triplicate): 0, 10, 33, 100, 333, 1000 and 2500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Due to the limited solubility of the test substance in ultrapure water, acetone was used as vehicle.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- (sterility control)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with S9-mix
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- 2.5 µg/plate, in DMSO, for TA 1535, TA 1537, TA 100, TA 98; 60 µg/plate, in DMSO, for E. coli WP2 uvrA
- Positive controls:
- yes
- Remarks:
- without S9-mix
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)
- Remarks:
- 5 µg/plate, in DMSO, for TA 1535 and TA 100
- Positive controls:
- yes
- Remarks:
- without S9-mix
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 100 µg/plate, in DMSO, for TA 1537
Migrated to IUCLID6: (AAC)
- Positive controls:
- yes
- Remarks:
- without S9-mix
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- 5 µg/plate, in DMSO, for E. coli WP2 uvrA
Migrated to IUCLID6: (4-NQO)
- Positive controls:
- yes
- Remarks:
- (without S9-mix)
- Positive control substance:
- other: 4-nitro-o-phenylendiamine (NOPD)
- Remarks:
- 10 µg/plate, in DMSO, for TA 98
- Details on test system and experimental conditions:
- In the standard plate test, tubes were filled with 2mL portions of soft agar and kept in a water bath at 42-45°C. This soft agar consisted of 100 mL agar and 10 mL amino acid solution. As amino acid solution for the soft agar was used 0.5 mM histidine and 0.5 mM biotin for TA strains and 0.5 mM tryptophan for the E. coli strain.
Then following components are added:
0.1 mL test solution or vehicle
0.1 mL fresh bacterial culture
0.5 mL S9 -mix or phosphate buffer
After mixing samples with S. typhimurium strains were were poured onto Vogel-Bonner (minimal glucose agar plates) plate and incubated for 48 - 72 hrs in the dark at 37°C.
After mixing samples with the E.coli train were poured onto SA1 selective agar plates ( minimal agar prepared according to Green and Muriel, Mut Res 38: 3-32, 1976) and incubated for 48 - 72 hrs in the dark at 37°C.
For the preincubation test 0.1 mL test solution or vehicle, 0.1 mL bacterial suspension and 0.5 mL of the S9 mix were incubated at 37°C for 20 minutes (Yahagi et al., Mut Res 48: 121-129,1977; Matsushima et al. In: Norpoth, K.H. and R.C. Garner, Short-Term Test Systems for Detecting Carcinogens. Springer Verlag Berlin, Heidelberg, New York,1980). After addition of 2 mL soft agar samples were poured onto agar plates and incubated again at 37°C for 48 to 72 hrs.
For the E. coli strain, plate test differed again in mixture of amino acid solution of the soft agar, the histidine component used for the TA strains being replaced by tryptophan.
Triplicate testing was done. - Evaluation criteria:
- An assay is accepted when the following criteria are met:
1.) number of colonies in the negative control is in the historical control range
2.) no indication of bacterial contamination (checked by sterility control)
3.) number of colonies in the positive controls are in the range of historical control data
4.) titer of viable bacteria is ≥ 10 E+9/mL
Toxicity is detected by:
1.) decrease in the number of revertants
2.) titer reduction
3.) clearing or diminution of the background lawn
Precipitation:
As long as no interference between precipitation and colony counting occurs is 5 mg/plate set as maximum dose even for relatively insoluble compounds.
A test chemical is to be considered as mutagenic when:
1.) increase of number of revertant colonies is reproducible and dose-related.
2.) in at least 1 tester strain doubling of colony counts with or without S-9 mix or after adding a metabolizing system is seen.
A test chemical is to be considered as non-mutagenic when:
1.) the number of revertants is inside the range of historical negative control data in 2 experiments performed independently from each other.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- No increase in number of revertants was observed.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Decrease in the number of his+ or trp+ revertants, slight reduction in the titer observed depending on the strain and test conditions from about 2 500 μg/plate onward.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- No increase in number of revertants was observed.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, slight reduction in the titer, observed depending on the strain and test conditions from about 1 000 μg/plate onward.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation:
Precipitation of the test substance was observed in the standard plate test from 333 μg/plate onward (without S9 mix) and from 1000 μg/plate onward (with S9 mix).
Precipitation of the test substance was observed in the preincubation test from 1000 μg/plate onward with and without S9 mix. - Remarks on result:
- other: other: Standard Plate Test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table1: Results of Experiment I, Standard Plate Test
With or | Test substance | Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) | ||||
without | concentration | Base-pair substitution type | Frameshift type | |||
S9 mix | (µg/plate) | TA100 | TA1535 | E.coli WP2 | TA98 | TA1537 |
- | acetone | 68 ± 7 | 12 ± 2 | 44 ± 3 | 19 ± 3 | 6 ± 1 |
- | 33 | 78 ± 8 | 11 ± 2 | 43 ± 3 | 20 ± 3 | 6 ± 1 |
- | 100 | 79 ± 6 | 12 ± 1 | 42 ± 11 | 17 ± 2 | 7 ± 2 |
- | 333 | 75 ± 10 | 12 ± 2 | 41 ± 4 | 19 ± 2 | 6 ± 1 |
- | 1000 | 69 ± 6 | 11 ± 2 | 40 ± 7 | 17 ± 2 | 5 ± 2 |
- | 2500 | 40 ± 12 | 7 ± 1 | 28 ± 2 | 12 ± 4 | 3 ± 2 |
- | 5000 | 6 ± 1 | 4 ± 2 | 21 ± 6 | 3 ± 1 | 1 ± 0 |
positive controls, -S9 | Name | MNNG | MNNG | 4 -NQO | NOPD | AAC |
Concentration [µg/plate] | 5.0 | 5.0 | 5.0 | 10 | 2.5 | |
Mean No. of colonies/plate (average of 3 ± SD) | 672 ± 93 | 637 ± 23 | 650 ± 44 | 846 ± 79 | 410 ± 20 | |
TA100 | TA1535 | E.coli WP2 | TA98 | TA1537 | ||
+ | acetone | 79 ± 7 | 13 ± 1 | 48 ± 3 | 22 ± 3 | 7 ± 1 |
+ | 33 | 81 ± 7 | 13 ± 3 | 44 ± 10 | 28 ± 4 | 7 ± 1 |
+ | 100 | 77 ± 2 | 12 ± 1 | 48 ± 2 | 22 ± 2 | 9 ± 0 |
+ | 333 | 78 ± 10 | 13 ± 2 | 47 ± 7 | 25 ± 4 | 6 ± 1 |
+ | 1000 | 81 ± 4 | 12 ± 2 | 45 ± 6 | 21 ± 5 | 7 ± 1 |
+ | 2500 | 58 ± 21 | 5 ± 2 | 35 ± 7 | 16 ± 2 | 3 ± 1 |
+ | 5000 | 15 ± 7 | 2 ± 2 | 29 ± 3 | 7 ± 2 | 1 ± 1 |
positive controls, +S9 | Name | 2 -AA | 2 -AA | 2 -AA | 2 -AA | 2 -AA |
Concentration [µg/plate] | 2.5 | 2.5 | 60 | 2.5 | 100 | |
Mean No. of colonies/plate (average ± SD) | 757 ± 43 | 126 ± 18 | 261 ± 28 | 651 ± 63 | 105 ± 5 |
Table2: Results of Experiment II, Preincubation Test
With or | Test substance | Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) | ||||
without | concentration | Base-pair substitution type | Frameshift type | |||
S9 mix | (µg/plate) | TA100 | TA1535 | E.coli WP2 | TA98 | TA1537 |
- | acetone | 74 ± 6 | 12 ± 2 | 44 ± 4 | 18 ± 3 | 7 ± 1 |
- | 10 | 79 ± 8 | 11 ± 2 | 42 ± 8 | 18 ± 4 | 7 ± 2 |
- | 33 | 72 ± 1 | 12 ± 4 | 38 ± 5 | 18 ± 7 | 8 ± 2 |
- | 100 | 73 ± 3 | 12 ± 1 | 42 ± 6 | 17 ± 3 | 6 ± 2 |
- | 333 | 72 ± 10 | 13 ± 2 | 43 ± 6 | 16 ± 2 | 7 ± 1 |
- | 1000 | 61 ± 11 | 9 ± 2 | 34 ± 6 | 11 ± 3 | 5 ± 3 |
- | 2500 | B/P | B/P | 13 ± 3 | B/P | B/P |
positive controls, -S9 | Name | MNNG | MNNG | 4 -NQO | NOPD | AAC |
Concentration [µg/plate] | 5.0 | 5.0 | 5.0 | 10 | 100 | |
Mean No. of colonies/plate (average of 3 ± SD) | 672 ± 93 | 721 ± 48 | 591 ± 39 | 566 ± 33 | 359 ± 34 | |
TA100 | TA1535 | E.coli WP2 | TA98 | TA1537 | ||
+ | acetone | 82 ± 10 | 13 ± 3 | 44 ± 9 | 27 ± 6 | 9 ± 1 |
+ | 10 | 88 ± 14 | 11 ± 1 | 44 ± 12 | 28 ± 8 | 9 ± 1 |
+ | 33 | 88 ± 7 | 13 ± 4 | 47 ± 8 | 28 ± 12 | 8 ± 3 |
+ | 100 | 81 ± 8 | 14 ± 2 | 44 ± 7 | 29 ± 7 | 9 ± 3 |
+ | 333 | 82 ± 11 | 12 ± 3 | 50 ± 4 | 29 ± 6 | 8 ± 1 |
+ | 1000 | 70 ± 6 | 13 ± 2 | 31 ± 9 | 25 ± 4 | 8 ± 4 |
+ | 2500 | 52 ± 6 | 8 ± 2 | 18 ± 4 | 19 ± 3 | 6 ± 1 |
positive controls, +S9 | Name | 2 -AA | 2 -AA | 2 -AA | 2 -AA | 2 -AA |
Concentration [µg/plate] | 2.5 | 2.5 | 60 | 2.5 | 2.5 | |
Mean No. of colonies/plate (average ± SD) | 860 ± 67 | 136 ± 19 | 258 ± 17 | 599 ± 47 | 120 ± 13 |
P = Precipitation; B = Reduced Background growth
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
CLP: not classified
DSD: not classified
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