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EC number: 413-750-2 | CAS number: 171090-93-0 ANOX 1315; ANOX BF; DURAD AX 38
- 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
- Study period:
- 24 April 2014 to 15 January 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals; Guideline no. 471: "Genetic Toxicology: Bacterial Reverse Mutation Test". (adopted July 21, 1997).
- Deviations:
- yes
- Remarks:
- See "Any other information" for details
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- European Community (EC). Commission regulation (EC) No. 440/2008, Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.13/14: "Mutagenicity: Reverse Mutation Test using Bacteria”. Official Journal of the European Union No. L142, 31 May 2008.
- Deviations:
- yes
- Remarks:
- See "Any other information" for details
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
Method
- Target gene:
- histidine and tryptophan
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Test system Salmonella typhimurium bacteria and Escherichia coli bacteria
Rationale Recommended test system in international guidelines (e.g. OECD, EC and MITI).
Source Trinova Biochem GmbH, Germany (Master culture from Dr. Bruce N. Ames) (TA1535: 2006, TA1537: 2009, TA98: 2006, TA100: 2006) and (Master culture from The National Collections of Industrial and Marine Bacteria, Aberdeen, UK) (WP2uvrA, 2008) - Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- Not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Metabolic activation system
Rat liver microsomal enzymes (S9 homogenate) was obtained from Trinova Biochem GmbH, Giessen, Germany and was prepared from male Sprague Dawley rats that had been injected intraperitoneal with Aroclor 1254 (500 mg/kg).
Preparation of S9-mix
S9-mix was prepared immediately before use and kept on ice. S9-mix components contained per 10 ml: 30 mg NADP (Randox) and 15.2 mg glucose-6-phosphate (Roche Diagnostics, Mannheim, Germany) in 5.5 ml or 5.0 ml Milli-Q water (first or second experiment respectively); 2 ml 0.5 M sodium phosphate buffer pH 7.4; 1 ml 0.08 M MgCl2 solution; 1 ml 0.33 M KCl solution. The above solution was filter (0.22 μm)-sterilized. To 9.5 ml of S9-mix components 0.5 ml S9-fraction was added (5% (v/v) S9-fraction) to complete the S9-mix in the first experiment and to 9.0 ml of S9-mix components 1.0 ml S9-fraction was added (10% (v/v) S9-fraction) to complete the S9-mix in the second experiment. - Test concentrations with justification for top dose:
- Range finding study: 5.4, 17, 52, 164, 512, 1600 & 5000 Source of S9 µg/plate
Main study: 52, 164, 512, 1600 & 5000 µg/plate
No justification detailed in the study report. - Vehicle / solvent:
- Solvent used: Ethanol
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 6-Chloro-9-(3-N-(2-Chloroethyl-amino)propylamino-2-methoxyacridine dichloride [ICR-191]; 2-aminoanthracene [2-AA]
- Details on test system and experimental conditions:
- First experiment
Seven concentrations of the test substance, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate were tested in triplicate in the tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA.
Second experiment
Based on the results of the first mutation assay, five doses (increasing with approximately half-log steps) of the test substance were selected and tested in triplicate in each strain in the second experiment. The highest concentration of ANOX® 1315 used in the second mutation assay was 5 mg/plate.
Experimental procedure
The test substance was tested both in the absence and presence of S9-mix in each strain, in two independent experiments.
The vehicle control and relevant positive controls were concurrently tested in each strain in the presence and absence of S9-mix.
Top agar in top agar tubes was melted by heating to 45°C. The following solutions were successively added to 3 ml molten top agar: 0.1 ml of a fresh bacterial culture (109 cells/ml) of one of the tester strains, 0.1 ml of a dilution of the test substance in ethanol, and either 0.5 ml S9-mix (in case of activation assays) or 0.5 ml 0.1 M phosphate buffer (in case of non-activation assays). The ingredients were mixed on a Vortex and the content of the top agar tube was poured onto a selective agar plate. After solidification of the top agar, the plates were inverted and incubated in the dark at 37.0 ± 1.0 °C for 48 h. After this period revertant colonies (histidine independent for Salmonella typhimurium bacteria and tryptophan independent for Escherichia coli) were counted.
Colony counting
The revertant colonies were counted automatically with the Sorcerer Colony Counter. Plates with sufficient test article precipitate to interfere with automated colony counting were counted manually and evidence of test article precipitate on the plates was recorded. The condition of the bacterial background lawn was evaluated, both macroscopically and microscopically by using a dissecting microscope. - Rationale for test conditions:
- In accordance with test guidelines.
- Evaluation criteria:
- Acceptability of the assay
A Salmonella typhimurium reverse mutation assay and/or Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
a) The negative control data (number of spontaneous revertants per plate) should be within the laboratory historical range for each tester strain.
b) The positive control chemicals should produce responses in all tester strains, which are within the laboratory historical range documented for each positive control substance. Furthermore, the mean plate count should be at least three times the concurrent vehicle control group mean.
c) The selected dose range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate.
Data evaluation and statistical procedures
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent vehicle control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three (3) times the concurrent vehicle control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three (3) times the concurrent vehicle control.
b) In case a positive response will be repeated, the positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision. - Statistics:
- No formal hypothesis testing was done.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium 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 examined
- True negative controls validity:
- not examined
- 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 examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- First mutation experiment
ANOX® 1315 was tested in the tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA with concentrations of 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate in the absence and presence of 5% (v/v) S9-mix.
Precipitate
Precipitation of ANOX® 1315 on the plates was observed at the start and at the end of the incubation period at concentrations of 1600 and 5000 μg/plate in all tester strains, except in tester strain TA1535 where the test substance already precipitated on the plates at 512 μg/plate in the absence of S9-mix.
Toxicity
To determine the toxicity of ANOX® 1315, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined.
No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
Mutagenicity
No biologically increase in the number of revertants was observed upon treatment with ANOX® 1315 under all conditions tested.
In strain TA1535, fluctuations in the number of revertant colonies above the laboratory historical control data range were observed in the absence and presence of S9-mix at several dose levels. However, since the increases were not three-fold (a maximum of 1.4-fold was reached), these increases were not considered to be relevant.
In strain TA100, fluctuations in the number of revertant colonies above the laboratory historical control data range were observed in the presence of S9-mix at several dose levels. However, since the increases were not two-fold (a maximum of 1.1-fold was reached), these increases were not considered to be relevant.
Second mutation assay
To obtain more information about the possible mutagenicity of ANOX® 1315, a second mutation experiment was performed in the absence and presence of 10% (v/v) S9-mix. Based on the results of the first mutation experiment, ANOX® 1315 was tested up to concentrations of 5000 μg/plate.
Precipitate
Precipitation of ANOX® 1315 on the plates was observed at the start of the incubation period at the concentration of 5000 μg/plate and at 1600 and 5000 μg/plate at the end of the incubation period.
Toxicity
The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed.
Mutagenicity
No biologically relevant increase in the number of revertants was observed upon treatment with ANOX® 1315 under all conditions tested.
In strain TA1535, fluctuations in the number of revertant colonies above the laboratory historical control data range were observed in the presence of S9-mix at several dose levels. However, since no increase above the concurrent vehicle control was seen, these increases were not considered to be relevant.
Any other information on results incl. tables
TABLE OF RESULTS
Range Finding Study
Name of test substance: ANOX® 1315
Date of experiment: from 24 April 2014 to 28 April 2014 |
||||||
|
||||||
S9-mix (-) |
Dose level per plate (µg/plate) |
Number of Revertants, (Mean), +/- SD |
||||
|
|
|
|
|
||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
||
Solvent control (ethanol) |
29 (30) 30 0.6 30 |
4 (6) 4 3.5 10 |
20 (18) 19 3.2 14 |
124 (130) 121 12.5 144 |
38 (28) 15 11.8 31 |
|
5.4 |
34 (31) 38 9.5 20 |
12 (6) 3 5.2 3 |
20 (18) 16 2.1 19 |
136 (131) 141 12.7 117 |
23 (30) 23 12.1 44 |
|
17 |
46 (32) 31 13.5 19 |
8 (9) 14 5.0 4 |
27 (23) 26 6.1 16 |
131 (124) 122 6.7 118 |
31 (34) 30 6.1 41 |
|
52 |
23 (24) 26 1.7 23 |
4 (6) 5 3.2 10 |
19 (19) 16 3.0 22 |
131 (125) 131 10.4 113 |
22 (25) 19 8.5 35 |
|
164 |
30 NP (35) 39 NP 4.5 35 NP |
10 (7) 3 3.6 8 |
14 (19) 24 5.0 19 |
148 (139) 147 14.7 122 |
33 (26) 18 7.5 27 |
|
512 |
34 SP (34) 25 SP 1.2 33 SP |
11 NP (8) 7 NP 3.1 5 NP |
20 NP (16) 12 NP 4.0 16 NP |
150 NP (143) 131 NP 10.4 148 NP |
26 NP (36) 48 NP 11.2 33 NP |
|
1600 |
23 SP (31) 37 SP 7.2 33 SP |
7 SP (4) 1 SP 3.1 3 SP |
26 SP (23) 19 SP 3.6 24 SP |
148 SP (134) 137 SP 15.7 117 SP |
24 SP (35) 44 SP 10.1 37 SP |
|
5000 |
31 n SP (35) 41 n SP 5.1 34 n SP |
10 n SP (10) 8 n SP 1.5 11 n SP |
33 n SP (26) 19 n SP 7.0 26 n SP |
150 n SP (137) 140 n SP 14.7 121 n SP |
37 n SP (36) 31 n SP 4.2 39 n SP |
|
S9 mix (-) |
Name Dose level No. of revertants |
SA |
ICR-191 |
NF |
MMS |
4-NQO |
5 |
2.5 |
10 |
650 |
10 |
||
628 (633) 641 7.0 630 |
324 (306) 313 21.8 282 |
905 (883) 887 23.7 858 |
1008 (999) 986 11.5 1003 |
1355 (1294) 1329 84.7 1197 |
MMS methylmethanesulphonate
SA sodium azide
4-NQO 4-nitroquinoline N-oxide
NF 2-nitrofluorene
ICR-191 6-Chloro-9-(3-N-(2-Chloroethyl-amino)propylamino-2-methoxyacridine dihydrochloride
NP No precipitate
SP Slight precipitate
n Normal bacterial background lawn
Date of experiment: from 24 April 2014 to 28 April 2014 |
||||||
|
||||||
S9-mix (+) |
Dose level per plate (µg/plate) |
Number of Revertants, (Mean), +/- SD |
||||
|
|
|
|
|
||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
||
Solvent control (ethanol) |
31 (33) 35 2.1 34 |
7 (9) 7 2.9 12 |
24 (31) 31 7.0 38 |
140 (138) 117 20.6 158 |
46 (38) 30 8.0 38 |
|
5.4 |
26 (29) 30 3.1 32 |
5 (9) 10 3.2 11 |
22 (25) 27 2.6 26 |
125 (125) 124 0.6 125 |
30 (30) 38 8.0 22 |
|
17 |
35 (36) 37 1.2 35 |
4 (8) 12 4.0 7 |
24 (28) 33 4.6 27 |
146 (141) 139 4.7 137 |
30 (30) 34 3.5 27 |
|
52 |
31 (37) 35 6.7 44 |
11 (10) 8 1.7 11 |
34 (35) 41 6.0 29 |
137 (130) 125 6.2 128 |
38 (33) 26 6.1 34 |
|
164 |
42 (41) 33 8.0 49 |
7 (8) 4 4.0 12 |
33 (28) 16 10.4 35 |
140 (133) 121 10.2 137 |
39 (35) 35 4.0 31 |
|
512 |
29 NP (32) 33 NP 2.3 33 NP |
7 NP (11) 12 NP 3.6 14 NP |
27 NP (26) 19 NP 6.1 31 NP |
137 NP (133) 146 NP 26.4 151 NP |
37 NP (37) 39 NP 2.0 35 NP |
|
1600 |
35 SP (43) 48 SP 6.7 45 SP |
7 SP (4) 1 SP 3.1 3 SP |
27 SP (26) 19 SP 6.1 31 SP |
137 SP (150) 161 SP 12.1 152 SP |
31 SP (39) 50 SP 10.0 35 SP |
|
5000 |
39 n SP (47) 50 n SP 7.0 52 n SP |
19 n SP (22) 18 n SP 5.5 28 n SP |
30 n SP (39) 49 n SP 9.5 38 n SP |
133 n SP (141) 144 n SP 7.0 146 n SP |
38 n SP (43) 46 n SP 4.2 44 n SP |
|
S9 mix (+) |
Name Dose level No. of revertants |
2AA |
2AA |
2AA |
2AA |
2AA |
2.5 |
2.5 |
1 |
1 |
15 |
||
256 (256) 265 8.5 248 |
381 (389) 414 22.5 371 |
705 (667) 624 40.7 672 |
1189 (1203) 1262 53.0 1159 |
180 (176) 163 11.9 186 |
2AA 2-aminoanthracene
NP No precipitate
SP Slight precipitate
n Normal bacterial background lawn
TABLE OF RESULTS
Main Study
Name of test substance: ANOX® 1315
Date of experiment: from 01 May 2014 to 05 May 2014 |
||||||
|
||||||
S9-mix (-) |
Dose level per plate (µg/plate) |
Number of Revertants, (Mean), +/- SD |
||||
|
|
|
|
|
||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
||
Solvent control (ethanol) |
30 (32) 29 4.9 38 |
12 (10) 11 2.6 7 |
20 (19) 20 1.2 18 |
129 (119) 109 10.0 118 |
27 (32) 24 10.8 44 |
|
52 |
24 (18) 22 9.3 7 |
19 (11) 1 9.1 12 |
30 (24) 23 5.1 20 |
113 (105) 90 13.0 112 |
33 (40) 39 7.5 48 |
|
164 |
16 (22) 23 5.6 27 |
10 (7) 5 2.9 5 |
29 (21) 26 11.9 7 |
106 (105) 94 10.1 114 |
27 (30) 33 3.1 31 |
|
512 |
22 NP (23) 20 NP 3.6 27 NP |
7 NP (9) 10 NP 1.7 10 NP |
34 NP (25) 22 NP 7.9 19 NP |
118 NP (117) 112 NP 4.2 120 NP |
29 NP (36) 48 NP 10.4 31 NP |
|
1600 |
20 SP (31) 42 SP 11.0 30 SP |
14 SP (9) 10 SP 5.6 3 SP |
16 SP (18) 27 SP 8.6 10 SP |
109 SP (97) 93 SP 11.0 88 SP |
33 SP (38) 48 SP 8.4 34 SP |
|
5000 |
31 n SP (30) 33 n SP 3.1 27 n SP |
18 n SP (13) 12 n SP 5.0 8 n SP |
24 n SP (22) 20 n SP 2.1 23 n SP |
116 n SP (115) 127 n SP 13.1 101 n SP |
42 n SP (36) 29 n SP 6.7 38 n SP |
|
S9 mix (-) |
Name Dose level No. of revertants |
SA |
ICR-191 |
NF |
MMS |
4-NQO |
5 |
2.5 |
10 |
650 |
10 |
||
804 (812) 793 23.5 838 |
517 (553) 584 33.8 558 |
834 (813) 842 43.5 763 |
926 (940) 932 19.3 962 |
1534 (1473) 1291 160.4 1594 |
MMS methylmethanesulphonate
SA sodium azide
4-NQO 4-nitroquinoline N-oxide
NF 2-nitrofluorene
ICR-191 6-Chloro-9-(3-N-(2-Chloroethyl-amino)propylamino-2-methoxyacridine dihydrochloride
NP No precipitate
SP Slight precipitate
n Normal bacterial background lawn
Date of experiment: from 01 May 2014 to 05 May 2014 |
||||||
|
||||||
S9-mix (+) |
Dose level per plate (µg/plate) |
Number of Revertants, (Mean), +/- SD |
||||
|
|
|
|
|
||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
||
Solvent control (ethanol) |
38 (36) 45 10.7 24 |
7 (12) 14 4.4 15 |
23 (28) 33 5.0 27 |
143 (142) 144 2.6 139 |
46 (46) 41 4.5 50 |
|
52 |
30 (22) 18 6.7 19 |
14 (11) 14 5.2 5 |
41 (38) 41 4.6 33 |
103 (107) 103 11.5 116 |
37 (42) 44 4.0 44 |
|
164 |
30 (34) 30 6.9 42 |
3 (6) 10 3.6 5 |
38 (40) 50 9.6 31 |
109 (110) 99 11.5 122 |
34 (38) 34 6.9 46 |
|
512 |
34 NP (27) 16 NP 9.5 30 NP |
10 NP (9) 11 NP 2.1 7 NP |
20 NP (30) 26 NP 12.5 44 NP |
141 NP (122) 116 NP 16.8 109 NP |
44 NP (43) 39 NP 3.6 46 NP |
|
1600 |
24 SP (27) 35 SP 6.7 23 SP |
5 SP (8) 15 SP 5.8 5 SP |
38 SP (35) 31 SP 3.5 35 SP |
98 SP (101) 113 SP 11.2 91 SP |
39 SP (46) 38 SP 12.4 60 SP |
|
5000 |
35 n SP (36) 39 n SP 2.3 35 n SP |
10 n SP (16) 22 n SP 6.0 15 n SP |
44 n SP (32) 22 n SP 11.1 30 n SP |
113 n SP (106) 107 n SP 8.1 97 n SP |
50 n SP (54) 46 n SP 11.2 67 n SP |
|
S9 mix (+) |
Name Dose level No. of revertants |
2AA |
2AA |
2AA |
2AA |
2AA |
2.5 |
5 |
1 |
2 |
15 |
||
220 (194) 192 25.1 170 |
612 (490) 484 118.6 375 |
718 (693) 679 21.7 682 |
1726 (1545) 1490 160.3 1420 |
288 (277) 249 24.4 294 |
2AA 2-aminoanthracene
NP No precipitate
SP Slight precipitate
n Normal bacterial background lawn
Applicant's summary and conclusion
- Conclusions:
- All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments.
The negative control values were within the laboratory historical control data ranges, except for TA1535 in the presence of S9-mix (first and second experiment) and TA100 in the presence of S9-mix (first experiment).
The strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that ANOX® 1315 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
Evaluation of the mutagenic activity of ANOX® 1315 in the Salmonella typhimurium reverse mutation assay and the Escherichia coli reverse mutation assay (with independent repeat).
ANOX® 1315 was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli (WP2uvrA). The test was performed in two independent experiments in the presence and absence of S9-mix (rat liver S9-mix induced by Aroclor 1254).
The study procedures described in this report were based on the most recent OECD, EC and Japanese guidelines.
Batch WBF3F0004 of ANOX® 1315 was a clear yellow viscous liquid with a purity of 93.5% by GC. The test substance was dissolved in ethanol.
In the first mutation assay, ANOX® 1315 was tested up to concentrations of 5000 μg/plate in the absence and presence of 5% (v/v) S9-mix. ANOX® 1315 precipitated on the plates at dose levels of 1600 and 5000 μg/plate in all tester strains, except in tester strain TA1535 where the test substance already precipitated on the plates at 512 μg/plate in the absence of S9-mix. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed.
In the second mutation assay, ANOX® 1315 was tested up to concentrations of 5000 μg/plate in the absence and presence of 10% (v/v) S9-mix. ANOX® 1315 precipitated on the plates at dose levels of 1600 and 5000 μg/plate. The bacterial background lawn was not reduced at any of the concentrations tested and no decrease in the number of revertants was observed.
ANOX® 1315 did not induce a biologically significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.
The negative control values were within the laboratory historical control data ranges, except for TA1535 in the presence of S9-mix (first and second experiment) and TA100 in the presence of S9-mix (first experiment). However, since these values were just outside the limit of the range, the validity of the test was considered to be not affected.
The strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that ANOX® 1315 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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