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EC number: 254-099-2 | CAS number: 38714-47-5
- 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:
- 27 January 2017 - 10 February 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- Aug 1998,
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tetraamminezinc(2+) carbonate
- EC Number:
- 254-099-2
- EC Name:
- Tetraamminezinc(2+) carbonate
- Cas Number:
- 38714-47-5
- Molecular formula:
- Zn(NH3)4 CO3
- IUPAC Name:
- Tetraamminezinc(2+) carbonate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kampagne 02/2014
- Expiration date of the lot/batch: February 18, 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from phenobarbital (i.p.) and β-naphthoflavone (p.o) induced rat liver
- Test concentrations with justification for top dose:
- 0; 100; 333; 1000; 3333; 10000 and 30000 μg/plate (Standard Plate Assay)
0; 100; 333; 1000; 3333; 10000 and 30000 μg/plate (Preincubation Test)
In this study, due to the purity of the test substance 30 mg/plate was used as top dose in all experiments. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:
ultrapure water
- Justification for choice of solvent/vehicle:
Due to the good solubility of the test substance in water, water was used as vehicle.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- ultrapure water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ultrapure water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Untreated negative controls:
- yes
- Remarks:
- ultrapure water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ultrapure water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)
- Untreated negative controls:
- yes
- Remarks:
- ultrapure water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ultrapure water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine (NOPD)
- Untreated negative controls:
- yes
- Remarks:
- ultrapure water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ultrapure water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- yes
- Remarks:
- ultrapure water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ultrapure water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: about 20 minutes
- Exposure duration: 48 – 72 hours
NUMBER OF REPLICATIONS: 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
Toxicity detected by a
- decrease in the number of revertants (factor ≤ 0.6)
- clearing or diminution of the background lawn (= reduced his- or trp- background growth) was recorded for all test groups both with and without S9 mix in all experiments. - Evaluation criteria:
- The test substance was considered positive in this assay if the following criteria were met:
- A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
- The number of revertants for all tester strains were within the range of the historical negative control data under all experimental conditions in at least two experiments carried out independently of each other.
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:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ or trp+ revertants) was occasionally observed depending on the strain and test conditions from about 10000 μg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ or trp+ revertants) was occasionally observed depending on the strain and test conditions from about 10000 μg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ or trp+ revertants) was occasionally observed depending on the strain and test conditions from about 10000 μg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ or trp+ revertants) was occasionally observed depending on the strain and test conditions from about 10000 μg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ or trp+ revertants) was occasionally observed depending on the strain and test conditions from about 10000 μg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test substance precipitation was found with and without S9 mix.
HISTORICAL CONTROL DATA: Please refer to tables 5 and 6.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ or trp+revertants) was occasionally observed depending on the strain and test conditions from about
10000 μg/plate onward. Please refer to table 7.
Any other information on results incl. tables
Table 1: Without metabolic activation (Standard Plate Test)
Strain |
Test group |
Dose [µg/mL] |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
Water |
- |
12.3 |
2.3 |
- |
11,11,15 |
|
Test item |
100 |
11.3 |
3.5 |
0.9 |
15, 8, 11 |
|
|
333 |
13.3 |
4.2 |
1.1 |
18, 12, 10 |
|
|
1000 |
12.0 |
1.0 |
1.0 |
13, 11, 12 |
|
|
3333 |
11.3 |
3.5 |
0.9 |
8,11,15 |
|
|
10000 |
11.7 |
0.6 |
0.9 |
11, 12, 12 |
|
|
30000 |
10.7 |
1.2 |
0.9 |
10, 10,12 |
|
MNNG |
5.0 |
3644.0 |
519.9 |
295.5 |
4241, 3400, 3291 |
|
||||||
TA 100 |
Water |
- |
110.0 |
10.6 |
- |
122, 102, 106 |
|
Test item |
100 |
124.7 |
8.1 |
1.1 |
134, 119, 121 |
|
|
333 |
120.3 |
13.6 |
1.1 |
125, 105, 131 |
|
|
1000 |
109.0 |
6.6 |
1.0 |
110, 115, 102 |
|
|
3333 |
100.7 |
13.1 |
0.9 |
105, 111, 86 |
|
|
10000 |
106.0 |
9.0 |
1.0 |
97, 115, 106 |
|
|
30000 |
120.3 |
10.5 |
1.1 |
131, 110, 120 |
|
MNNG |
5.0 |
4493.0 |
23.9 |
40.8 |
4488, 4472, 4519 |
|
||||||
TA 1537 |
Water |
_ |
6.7 |
2.5 |
- |
9, 7, 4 |
|
Test item |
100 |
9.3 |
3.2 |
1.4 |
13, 7, 8 |
|
|
333 |
10.7 |
2.1 |
1.6 |
10, 9, 13 |
|
|
1000 |
6.3 |
3.2 |
1.0 |
4, 5,10 |
|
|
3333 |
6.7 |
2.5 |
1.0 |
9, 7, 4 |
|
|
10000 |
7.3 |
2.5 |
1.1 |
10, 7, 5 |
|
|
30000 |
9.0 |
0.0 |
1.4 |
9, 9, 9 |
|
AAC |
100 |
763.7 |
72.6 |
114.6 |
680, 801, 810 |
|
||||||
TA 98 |
Water |
- |
19.3 |
4.6 |
- |
22, 14, 22 |
|
Test item |
100 |
18.0 |
1.7 |
0.9 |
17, 20, 17 |
|
|
333 |
18.7 |
6.7 |
1.0 |
17, 26, 13 |
|
|
1000 |
22.3 |
3.5 |
1.2 |
22, 26, 19 |
|
|
3333 |
18.0 |
6.2 |
0.9 |
20, 11,23 |
|
|
10000 |
24.0 |
2.6 |
1.2 |
26, 21,25 |
|
|
30000 |
21.0 |
4.0 |
1.1 |
21, 25, 17 |
|
NOPD |
10 |
575.7 |
10.0 |
29.8 |
575, 566, 586 |
|
||||||
E. coli |
Water |
- |
28.7 |
3.5 |
- |
25, 32, 29 |
|
Test item |
100 |
35.7 |
1.5 |
1.2 |
37, 34, 36 |
|
|
333 |
25.7 |
5.9 |
0.9 |
19, 30, 28 |
|
|
1000 |
29.3 |
15.0 |
1.0 |
15, 28, 45 |
|
|
3333 |
23.7 |
3.1 |
0.8 |
23, 27, 21 |
|
|
10000 |
19.0 |
1.0 |
0.7 |
20, 18, 19 |
|
|
30000 |
21.3 |
6.7 |
0.7 |
29, 17, 18 |
|
4-NQO |
5 |
1079.0 |
47.0 |
37.6 |
1077, 1127, 1033 |
Table 2: With metabolic activation (Standard Plate Test)
Strain |
Test group |
Dose |
Mean |
Standard |
Factor |
Individual revertant colony |
|
|
(µg/plate) |
revertants |
deviation |
|
counts |
|
||||||
TA 1535 |
Water |
- |
13.3 |
1.5 |
- |
15, 13, 12 |
|
Test item |
100 |
7.3 |
2.5 |
0.6 |
10, 7, 5 |
|
|
333 |
10.3 |
4.2 |
0.8 |
7, 15, 9 |
|
|
1000 |
7.7 |
1.2 |
0.6 |
7, 7, 9 |
|
|
3333 |
9.0 |
1.7 |
0.7 |
11, 8, 8 |
|
|
10000 |
7.7 |
2.1 |
0.6 |
7, 10 ,6 |
|
|
30000 |
10.3 |
2.9 |
0.8 |
12, 12, 7 |
|
2-AA |
2.5 |
207.7 |
9.0 |
15.6 |
207, 199, 217 |
|
||||||
TA 100 |
Water |
- |
125.3 |
10.5 |
- |
115, 125, 136 |
|
Test item |
100 |
112.3 |
14.7 |
0.9 |
107, 129, 101 |
|
|
333 |
130.7 |
11.9 |
1.0 |
127, 144, 121 |
|
|
1000 |
122.7 |
9.6 |
1.0 |
133, 121, 114 |
|
|
3333 |
112.3 |
15.0 |
0.9 |
121, 95, 121 |
|
|
10000 |
123.3 |
9.7 |
1.0 |
121, 115,134 |
|
|
30000 |
126.7 |
16.1 |
1.0 |
115, 145,120 |
|
2-AA |
2.5 |
2560.3 |
279.1 |
20.4 |
2499, 2865, 2317 |
|
||||||
TA 1537 |
Water |
- |
9.7 |
4.2 |
- |
5, 11,13 |
|
Test item |
100 |
7.0 |
1.7 |
0.7 |
8, 8, 5 |
|
|
333 |
8.7 |
1.5 |
0.9 |
9, 7, 10 |
|
|
1000 |
7.0 |
1.7 |
0.7 |
6, 9, 6 |
|
|
3333 |
10.0 |
2.6 |
1.0 |
11,7,12 |
|
|
10000 |
10.3 |
3.1 |
1.1 |
11,13, 7 |
|
|
30000 |
9.0 |
1.0 |
0.9 |
8, 10, 9 |
|
2-AA |
2.5 |
206.7 |
31.7 |
21.4 |
243, 192,185 |
|
||||||
TA98 |
Water |
_ |
23.3 |
3.8 |
- |
19, 25, 26 |
|
Test item |
100 |
31.0 |
1.0 |
1.3 |
32, 30, 31 |
|
|
333 |
25.3 |
5.0 |
1.1 |
30, 26, 20 |
|
|
1000 |
26.7 |
3.5 |
1.1 |
27, 23, 30 |
|
|
3333 |
26.7 |
4.2 |
1.1 |
30, 22, 28 |
|
|
10000 |
27.0 |
8.7 |
1.2 |
23, 21, 37 |
|
|
30000 |
21.7 |
4.7 |
0.9 |
27, 18, 20 |
|
2-AA |
2.5 |
1579.7 |
106.4 |
67.7 |
1596,1466, 1677 |
|
||||||
E. Coli |
Water |
- |
23.7 |
5.5 |
- |
30, 21, 20 |
|
Test item |
100 |
30.3 |
6.7 |
1.3 |
36, 23, 32 |
|
|
333 |
22.7 |
5.9 |
1.0 |
27, 25, 16 |
|
|
1000 |
22.0 |
2.6 |
0.9 |
21, 25, 20 |
|
|
3333 |
19.7 |
4.7 |
0.8 |
25, 16, 18 |
|
|
10000 |
26.0 |
8.5 |
1.1 |
18, 25, 35 |
|
|
30000 |
24.7 |
4.9 |
1.0 |
27, 19, 28 |
|
2-AA |
60 |
131.7 |
2.5 |
5.6 |
134, 132,129 |
Table 3: Without metabolic activation (Preincubation Test)
Strain |
Test group |
Dose (µg/mL) |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
Water |
- |
9.3 |
2.3 |
- |
8, 8, 12 |
|
Test item |
100 |
9.7 |
2.1 |
1.0 |
9, 12, 8 |
|
|
333 |
10.0 |
5.3 |
1.1 |
8, 6, 16 |
|
|
1000 |
9.7 |
1.5 |
1.0 |
8, 10, 11 |
|
|
3333 |
11.0 |
5.2 |
1.2 |
14, 5, 14 |
|
|
10000 |
13.3 |
3.2 |
1.4 |
12,11,17 |
|
|
30000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|
MNNG |
5.0 |
2935.7 |
92.8 |
314.5 |
2830, 3004, 2973 |
|
||||||
TA 100 |
Water |
- |
104.7 |
6.7 |
- |
99, 103, 112 |
|
Test item |
100 |
110.7 |
9.9 |
1.1 |
104, 122, 106 |
|
|
333 |
127.0 |
8.7 |
1.2 |
122. 137, 122 |
|
|
1000 |
121.7 |
8.1 |
1.2 |
123, 113, 129 |
|
|
3333 |
112.7 |
2.1 |
1.1 |
112, 115, 111 |
|
|
10000 |
103.3 |
6.7 |
1.0 |
99, 111, 100 |
|
|
30000 |
108.7 |
22.2 |
1.0 |
129 B, 112 B, 85 B |
|
MNNG |
5.0 |
2313.0 |
134.0 |
22.1 |
2271, 2205, 2463 |
|
||||||
TA 1537 |
Water |
_ |
8.0 |
3.6 |
- |
12, 5, 7 |
|
Test item |
100 |
9.3 |
0.6 |
1.2 |
9, 10, 9 |
|
|
333 |
10.7 |
1.5 |
1.3 |
12, 11,9 |
|
|
1000 |
6.3 |
4.0 |
0.8 |
4, 4,11 |
|
|
3333 |
9.7 |
0.6 |
1.2 |
9, 10, 10 |
|
|
10000 |
8.0 |
1.0 |
1.0 |
8, 7, 9 |
|
|
30000 |
4.7 |
3.1 |
0.6 |
4B, 2B, 8B |
|
AAC |
100 |
500.0 |
151.7 |
62.5 |
675, 405, 420 |
|
||||||
TA 98 |
Water |
- |
15.3 |
1.5 |
- |
14, 17, 15 |
|
Test item |
100 |
21.7 |
3.8 |
1.4 |
20, 19, 26 |
|
|
333 |
13.3 |
3.1 |
0.9 |
10, 14, 16 |
|
|
1000 |
14.7 |
1.5 |
1.0 |
13, 15, 16 |
|
|
3333 |
14.3 |
2.1 |
0.9 |
16, 15, 12 |
|
|
10000 |
19.0 |
4.4 |
1.2 |
22, 21, 14 |
|
|
30000 |
13.3 |
3.1 |
0.9 |
16 B, 10 B, 14 B |
|
NOPD |
10 |
604.3 |
41.1 |
39.4 |
649, 596, 568 |
|
||||||
E. coli |
Water |
- |
34.0 |
7.0 |
- |
27, 34, 41 |
|
Test item |
100 |
26.7 |
9.7 |
0.8 |
29, 16, 35 |
|
|
333 |
28.7 |
14.8 |
0.8 |
25, 45, 16 |
|
|
1000 |
30.7 |
10.0 |
0.9 |
27, 23, 42 |
|
|
3333 |
29.3 |
10.2 |
0.9 |
25, 41,22 |
|
|
10000 |
19.7 |
5.0 |
0.6 |
25, 15, 19 |
|
|
30000 |
18.7 |
7.8 |
0.5 |
21 B, 10 B, 25 B |
|
4-NQO |
5 |
187.0 |
41.1 |
5.5 |
230, 148, 183 |
B = Reduced background growth
Table 4: Without metabolic activation (Preincubation Test)
Strain |
Test group |
Dose |
Mean |
Standard |
Factor |
Individual revertant colony |
|
|
(µg/plate) |
revertants |
deviation |
|
counts |
|
||||||
TA 1535 |
Water |
- |
10.0 |
1.0 |
- |
9,11,10 |
|
Test item |
100 |
10.3 |
4.5 |
1.0 |
10, 6,15 |
|
|
333 |
6.7 |
1.2 |
0.7 |
6, 8,6 |
|
|
1000 |
7.7 |
3.2 |
0.8 |
10,4,9 |
|
|
3333 |
10.7 |
0.6 |
1.1 |
11,11,10 |
|
|
10000 |
11.3 |
2.1 |
1.1 |
13, 9,12 |
|
|
30000 |
9.7 |
1.5 |
1.0 |
10B, 11 B, 8B |
|
2-AA |
2.5 |
216.7 |
31.1 |
21.7 |
242,182, 226 |
|
||||||
TA 100 |
Water |
- |
114.0 |
13.5 |
- |
129, 103, 110 |
|
Test item |
100 |
116.7 |
25.4 |
1.0 |
122, 139, 89 |
|
|
333 |
107.7 |
22.0 |
0.9 |
129, 109, 85 |
|
|
1000 |
112.0 |
11.4 |
1.0 |
107, 104, 125 |
|
|
3333 |
112.7 |
9.3 |
1.0 |
117, 102, 119 |
|
|
10000 |
104.3 |
9.5 |
0.9 |
95, 114, 104 |
|
|
30000 |
159.7 |
8.1 |
1.4 |
169 B, 155 B, 155 B |
|
2-AA |
2.5 |
2553.3 |
116.4 |
22.4 |
2647, 2423, 2590 |
|
||||||
TA 1537 |
Water |
- |
10.0 |
2.0 |
- |
8, 10, 12 |
|
Test item |
100 |
11.7 |
4.2 |
1.2 |
15, 7,13 |
|
|
333 |
16.0 |
3.5 |
1.6 |
18, 12, 18 |
|
|
1000 |
15.3 |
3.8 |
1.5 |
18, 11, 17 |
|
|
3333 |
15.0 |
3.0 |
1.5 |
15, 18, 12 |
|
|
10000 |
14.0 |
2.6 |
1.4 |
17, 13, 12 |
|
|
30000 |
3.7 |
4.0 |
0.4 |
8 B, 0B, 3B |
|
2-AA |
2.5 |
168.3 |
22.3 |
16.8 |
185, 143, 177 |
|
||||||
TA98 |
Water |
_ |
25.3 |
8.1 |
- |
30, 30, 16 |
|
Test item |
100 |
32.7 |
5.0 |
1.3 |
32, 38, 28 |
|
|
333 |
31.0 |
0.0 |
1.2 |
31,31, 31 |
|
|
1000 |
29.3 |
6.4 |
1.2 |
34, 32, 22 |
|
|
3333 |
36.7 |
5.8 |
1.4 |
40, 30,40 |
|
|
10000 |
25.3 |
3.5 |
1.0 |
22, 25, 29 |
|
|
30000 |
21.7 |
7.6 |
0.9 |
20, 30, 15 |
|
2-AA |
2.5 |
1884.7 |
148.4 |
74.4 |
1797,1801,2056 |
|
||||||
E. coli |
Water |
- |
26.7 |
8.0 |
- |
26, 35. 19 |
|
Test item |
100 |
24.3 |
7.5 |
0.9 |
20, 20, 33 |
|
|
333 |
19.7 |
2.1 |
0.7 |
22, 18, 19 |
|
|
1000 |
23.3 |
7.6 |
0.9 |
30, 15, 25 |
|
|
3333 |
29.3 |
2.1 |
1.1 |
30, 31, 27 |
|
|
10000 |
15.7 |
1.2 |
0.6 |
15, 17, 15 |
|
|
30000 |
33.0 |
3.0 |
1.2 |
33, 30, 36 |
|
2-AA |
60 |
125.7 |
51.1 |
4.7 |
109, 85, 183 |
B = Reduced background growth
Table 5: Historical Negative Controls (based on Sorcerer Counter / Ames Study Manager System (Apr 15 - Apr 16))
Strain |
S9 Mix |
Vehicle |
No. of Plates |
No. of Values |
Min |
Max |
Mean |
SD |
TA 1535 |
Without |
(All) |
495 |
178 |
6 |
17 |
10 |
2.2 |
|
With |
(All) |
483 |
177 |
6 |
18 |
10 |
2.1 |
|
||||||||
TA 100 |
Without |
(All) |
501 |
179 |
69 |
140 |
95 |
9.9 |
|
With |
(All) |
492 |
179 |
76 |
150 |
100 |
12.3 |
|
||||||||
TA 1537 |
Without |
(All) |
501 |
178 |
5 |
12 |
7 |
1.5 |
|
With |
(All) |
504 |
178 |
5 |
16 |
8 |
2.2 |
|
||||||||
TA98 |
Without |
(All) |
501 |
178 |
12 |
30 |
18 |
3.1 |
|
With |
(All) |
495 |
178 |
13 |
38 |
24 |
4.7 |
|
||||||||
E. coli |
Without |
(All) |
468 |
177 |
12 |
33 |
22 |
4.0 |
|
With |
(All) |
468 |
178 |
13 |
35 |
23 |
4.0 |
Table 6: Historical Positive Controls (based on Sorcerer Counter / Ames Study Manager System (Apr 15 - Apr 16))
Strain |
S9 Mix |
Positive |
No. of |
No. of |
Min |
Max |
Mean |
SD |
|
||||||||
TA 1535 |
Without |
MNNG |
342 |
116 |
1174 |
6612 |
4063 |
1308.8 |
|
||||||||
TA 100 |
Without |
MNNG |
351 |
118 |
1125 |
5557 |
3331 |
1021.5 |
|
||||||||
TA 1537 |
Without |
AAC |
345 |
117 |
253 |
1858 |
975 |
339.9 |
|
||||||||
TA98 |
Without |
NOPD |
348 |
117 |
271 |
1119 |
486 |
183.3 |
|
||||||||
E. coli |
Without |
4-NQO |
333 |
115 |
133 |
1552 |
884 |
442.4 |
Table 7: Toxicity: Decreased revertant numbers were observed at following concentrations (μg/plate)
Experiment |
S9 |
TA1535 |
TA100 |
TA 1537 |
TA 98 |
E.coli |
1st-SPT |
Without |
- |
||||
|
With |
10000 |
- |
- |
- |
- |
2nd-PIT |
Without |
30000 |
- |
30000 |
- |
10000-30000 |
|
With |
- |
- |
30000 |
- |
10000 |
|
|
|
|
|
||
Reduced background growth was observed at following concentrations (μg/plate):
|
||||||
Experiment |
S9 |
TA1535 |
TA100 |
TA 1537 |
TA 98 |
E.coli |
1st-SPT |
Without |
- |
||||
|
With |
- |
||||
2nd-PIT |
Without |
30000 |
||||
|
With |
30000 |
30000 |
30000 |
- |
- |
- = no adverse effect observed
Applicant's summary and conclusion
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