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EC number: 208-753-9 | CAS number: 540-69-2
- 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
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:
- 2019-07-02 to 2019-11-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- 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)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ammonium formate
- EC Number:
- 208-753-9
- EC Name:
- Ammonium formate
- Cas Number:
- 540-69-2
- Molecular formula:
- CH2O2.H3N
- IUPAC Name:
- ammonium formate
- Test material form:
- solid: crystalline
Constituent 1
Method
- Target gene:
- his locus
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:
- DNA polymerase A deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
S9 Liver Mix
- source of S9 : rat; the S9 fraction of Phenobarbital (PB) and β-naphthoflavone (BNF)-induced rat liver was provided by Trinova Biochem GmbH (Rathenau Str. 2; D-35394 Giessen, Germany; Manufacturer: MOLTOX INC., P.O. BOX 1189; BOONE, NC 28607 USA).
- concentration or volume of S9 mix and S9 in the final culture medium 10% S9 Mix
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability) The Quality Control & Production Certificate of each lot of S9 was obtained from the supplier. - Test concentrations with justification for top dose:
- Selection of the concentration range for the initial mutation test was done on the basis of solubility test and concentration range finding test (informatory toxicity test). The chosen, already investigated concentration levels were not modified for the confirmatory mutation test. Based on the information about the solubility properties of the test item, a stock solution with a nominal concentration of 50 mg/mL was prepared in ultrapure water (ASTM Type I), and further diluted in 6 steps by factor of approximately √10.
The revertant colony numbers and the inhibition of the background lawn of auxotrophic cells of two of the tester strains (Salmonella typhimurium TA98, TA100) was determined at the concentrations of 5000; 1600; 500; 160; 50; 16 and 5 µg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO; aqueous solvents (water)
- Justification for choice of solvent/vehicle: In the study two types of vehicle control were used depending on the solubility of the test item and the solubility of positive control reference items.
Controls
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-Nitro-1,2-phenylenediamine, NPD for TA98 (without metabolic activation; 4µg/plate in DMSO); with metabolic activation 2-aminoanthracene for all strains (2µg/plat for S. typhimurium, 50µg/plate for E.coli)
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: Triplicate
- Number of independent experiments : Two
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): about 1 to 3E+09 cells/mL
- Test substance added in medium; in agar (plate incorporation); preincubation
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 min at 37°C
- Exposure duration/duration of treatment: 48h
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: Background growth inhibition
- Any supplementary information relevant to cytotoxicity: No
- Rationale for test conditions:
- As recommended by OECD guideline 471.
- Evaluation criteria:
- A test item is considered non-mutagenic if it produces neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation.
A test item is considered mutagenic if:
-a dose–related increase in the number of revertants occurs and/or;
-a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.
An increase is considered biologically relevant if:
-in strain Salmonella typhimurium TA100 the number of reversions is at least twice as high as the reversion rate of the vehicle control (water),
-in strain Salmonella typhimurium TA98, TA1535, TA1537 and Escherichia coli WP2 uvrA the number of reversions is at least three times higher than the reversion rate of the vehicle control (water).
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Data on pH: Not reported
- Data on osmolality: Not reported
- Possibility of evaporation from medium: No
- Water solubility: No effects observed
- Precipitation and time of the determination: No precipitation observed
RANGE-FINDING/SCREENING STUDIES (if applicable): A range-finding study was conducted in tester strains TA98 and TA100.
STUDY RESULTS
- Concurrent vehicle negative and positive control data : The revertant colonies per plate were within the range of the acceptance criteria
Ames test:
- Signs of toxicity : No
- Individual plate counts : see 'Any other information on results incl. tables'
- Mean number of revertant colonies per plate and standard deviation . see 'Any other information on results incl. tables'
HISTORICAL CONTROL DATA (with ranges, means and standard deviation, and 95% control limits for the distribution as well as the number of data)
- Positive historical control data: see 'Any other information on results incl. tables'
- Negative (solvent/vehicle) historical control data: see 'Any other information on results incl. tables'
Any other information on results incl. tables
Summary Table of the Results of the Concentration Range Finding Test
Concentration Range Finding Test (Informatory Toxicity Test) |
|
||||||||
Concentrations (mg/plate) |
Salmonella typhimuriumtester strains |
||||||||
TA 98 |
TA 100 |
||||||||
-S9 |
+S9 |
-S9 |
+S9 |
||||||
Mean values of revertants per plate and |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
|
Untreated Control |
13.3 |
0.85 |
35.7 |
0.84 |
82.0 |
1.02 |
100.0 |
1.20 |
|
DMSO Control |
19.0 |
1.00 |
35.3 |
1.00 |
– |
– |
99.7 |
1.00 |
|
Ultrapure Water Control |
15.7 |
1.00 |
42.7 |
1.00 |
80.3 |
1.00 |
83.0 |
1.00 |
|
5000 |
18.3 |
1.17 |
35.0 |
0.82 |
87.3 |
1.09 |
111.3 |
1.34 |
|
1600 |
19.0 |
1.21 |
35.0 |
0.82 |
89.0 |
1.11 |
113.7 |
1.37 |
|
500 |
23.0 |
1.47 |
32.7 |
0.77 |
84.3 |
1.05 |
111.0 |
1.34 |
|
160 |
20.0 |
1.28 |
28.3 |
0.66 |
89.7 |
1.12 |
105.7 |
1.27 |
|
50 |
15.3 |
0.98 |
34.0 |
0.80 |
78.7 |
0.98 |
106.0 |
1.28 |
|
16 |
19.3 |
1.23 |
34.3 |
0.80 |
81.7 |
1.02 |
107.0 |
1.29 |
|
5 |
22.7 |
1.45 |
34.3 |
0.80 |
80.3 |
1.00 |
103.7 |
1.25 |
|
NPD (4mg/plate) |
574.7 |
30.25 |
– |
– |
– |
– |
– |
– |
|
SAZ (2mg/plate) |
– |
– |
– |
– |
817.3 |
10.17 |
– |
– |
|
2AA (2mg/plate) |
– |
– |
797.3 |
22.57 |
– |
– |
928.0 |
9.31 |
|
Summary Table of the Results of the Initial Mutation Test
Initial Mutation Test (Plate Incorporation Test) |
||||||||||||||||||||
Concentrations (mg/plate) |
Salmonella typhimuriumtester strains |
Escherichiacoli |
||||||||||||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2uvrA |
||||||||||||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|||||||||||
Mean values of revertants per plate Mutation rate (MR) |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Untreated Control |
14.7 |
0.98 |
23.3 |
0.82 |
62.7 |
0.99 |
73.0 |
0.96 |
11.7 |
1.30 |
13.7 |
1.14 |
6.3 |
0.90 |
9.3 |
1.17 |
32.0 |
1.17 |
37.3 |
0.85 |
DMSO Control |
12.7 |
1.00 |
22.3 |
1.00 |
– |
– |
66.3 |
1.00 |
– |
– |
11.0 |
1.00 |
5.3 |
1.00 |
8.0 |
1.00 |
– |
– |
37.3 |
1.00 |
Ultrapure Water Control |
15.0 |
1.00 |
28.3 |
1.00 |
63.0 |
1.00 |
76.0 |
1.00 |
9.0 |
1.00 |
12.0 |
1.00 |
7.0 |
1.00 |
8.0 |
1.00 |
27.3 |
1.00 |
44.0 |
1.00 |
5000 |
21.3 |
1.42 |
22.3 |
0.79 |
83.0 |
1.32 |
93.3 |
1.23 |
8.7 |
0.96 |
10.7 |
0.89 |
7.0 |
1.00 |
7.0 |
0.88 |
40.0 |
1.46 |
47.3 |
1.08 |
1600 |
20.7 |
1.38 |
20.7 |
0.73 |
76.0 |
1.21 |
91.3 |
1.20 |
10.7 |
1.19 |
11.0 |
0.92 |
6.3 |
0.90 |
6.3 |
0.79 |
38.0 |
1.39 |
39.3 |
0.89 |
500 |
23.7 |
1.58 |
18.3 |
0.65 |
65.3 |
1.04 |
91.7 |
1.21 |
9.0 |
1.00 |
11.7 |
0.97 |
6.0 |
0.86 |
7.7 |
0.96 |
32.0 |
1.17 |
35.0 |
0.80 |
160 |
18.7 |
1.24 |
17.0 |
0.60 |
63.7 |
1.01 |
91.3 |
1.20 |
12.7 |
1.41 |
12.3 |
1.03 |
4.7 |
0.67 |
7.3 |
0.92 |
30.0 |
1.10 |
28.0 |
0.64 |
50 |
15.3 |
1.02 |
25.3 |
0.89 |
74.3 |
1.18 |
83.0 |
1.09 |
13.3 |
1.48 |
11.3 |
0.94 |
6.0 |
0.86 |
7.3 |
0.92 |
28.7 |
1.05 |
29.3 |
0.67 |
16 |
21.0 |
1.40 |
24.7 |
0.87 |
69.3 |
1.10 |
103.7 |
1.36 |
12.0 |
1.33 |
10.3 |
0.86 |
4.3 |
0.62 |
10.3 |
1.29 |
28.3 |
1.04 |
34.3 |
0.78 |
NPD (4mg/plate) |
417.3 |
32.95 |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
SAZ (2mg/plate) |
– |
– |
– |
– |
837.3 |
13.29 |
– |
– |
992.0 |
110.22 |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
9AA (50mg/plate) |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
569.3 |
106.75 |
– |
– |
– |
– |
– |
– |
MMS (2mL/plate) |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
688.0 |
25.17 |
– |
– |
2AA (2mg/plate) |
– |
– |
1936.0 |
86.69 |
– |
– |
770.7 |
11.62 |
– |
– |
194.7 |
17.70 |
– |
– |
112.3 |
14.04 |
– |
– |
– |
– |
2AA (50mg/plate) |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
180.7 |
4.84 |
Summary Table of the Results of the Confirmatory Mutation Test
Confirmatory Mutation Test (Pre-Incubation Test) |
||||||||||||||||||||
Concentrations (mg/plate) |
Salmonella typhimuriumtester strains |
Escherichiacoli |
||||||||||||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2uvrA |
||||||||||||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|||||||||||
Mean values of revertants per plate Mutation rate (MR) |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Untreated Control |
12.7 |
0.83 |
23.0 |
0.91 |
80.7 |
1.19 |
90.3 |
1.10 |
13.3 |
1.25 |
13.3 |
1.11 |
5.7 |
0.94 |
8.0 |
0.89 |
25.0 |
0.94 |
35.3 |
0.86 |
DMSO Control |
14.0 |
1.00 |
18.0 |
1.00 |
– |
– |
87.0 |
1.00 |
– |
– |
13.3 |
1.00 |
6.0 |
1.00 |
7.0 |
1.00 |
– |
– |
38.7 |
1.00 |
Ultrapure Water Control |
15.3 |
1.00 |
25.3 |
1.00 |
68.0 |
1.00 |
82.3 |
1.00 |
10.7 |
1.00 |
12.0 |
1.00 |
6.0 |
1.00 |
9.0 |
1.00 |
26.7 |
1.00 |
41.0 |
1.00 |
5000 |
16.0 |
1.04 |
14.0 |
0.55 |
62.7 |
0.92 |
130.7 |
1.59 |
14.3 |
1.34 |
11.7 |
0.97 |
5.3 |
0.89 |
8.7 |
0.96 |
32.7 |
1.23 |
43.3 |
1.06 |
1600 |
21.7 |
1.41 |
23.7 |
0.93 |
69.7 |
1.02 |
116.7 |
1.42 |
10.0 |
0.94 |
10.7 |
0.89 |
4.3 |
0.72 |
7.0 |
0.78 |
39.7 |
1.49 |
57.0 |
1.39 |
500 |
21.0 |
1.37 |
16.7 |
0.66 |
73.3 |
1.08 |
112.3 |
1.36 |
8.3 |
0.78 |
9.7 |
0.81 |
7.7 |
1.28 |
8.0 |
0.89 |
31.3 |
1.18 |
39.0 |
0.95 |
160 |
19.3 |
1.26 |
20.0 |
0.79 |
67.0 |
0.99 |
97.0 |
1.18 |
10.3 |
0.97 |
9.7 |
0.81 |
4.7 |
0.78 |
7.3 |
0.81 |
31.7 |
1.19 |
39.3 |
0.96 |
50 |
14.0 |
0.91 |
20.0 |
0.79 |
68.7 |
1.01 |
107.3 |
1.30 |
10.3 |
0.97 |
10.0 |
0.83 |
7.0 |
1.17 |
7.3 |
0.81 |
27.0 |
1.01 |
39.3 |
0.96 |
16 |
17.7 |
1.15 |
20.3 |
0.80 |
69.3 |
1.02 |
95.3 |
1.16 |
8.0 |
0.75 |
9.3 |
0.78 |
7.0 |
1.17 |
9.0 |
1.00 |
25.0 |
0.94 |
39.3 |
0.96 |
NPD (4mg/plate) |
460.0 |
32.86 |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
SAZ (2mg/plate) |
– |
– |
– |
– |
1072.0 |
15.76 |
– |
– |
1064.0 |
99.75 |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
9AA (50mg/plate) |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
355.3 |
59.22 |
– |
– |
– |
– |
– |
– |
MMS (2mL/plate) |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
893.3 |
33.50 |
– |
– |
2AA (2mg/plate) |
– |
– |
1056.0 |
58.67 |
– |
– |
770.7 |
8.86 |
– |
– |
190.3 |
14.28 |
– |
– |
87.7 |
12.52 |
– |
– |
– |
– |
2AA (50mg/plate) |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
197.0 |
5.09 |
Historical Control Values for Revertants/Plate (for the Period of 2016-2018)
|
Bacterial strains |
||||||
Historical control data of untreated control |
‑S9 |
|
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli |
Average |
18.9 |
88.7 |
10.7 |
7.9 |
28.0 |
||
SD |
2.0 |
10.5 |
0.6 |
0.7 |
3.7 |
||
Minimum |
8 |
62 |
4 |
2 |
12 |
||
Maximum |
36 |
128 |
21 |
18 |
50 |
||
+S9 |
|
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli |
|
Average |
24.0 |
106.5 |
11.2 |
8.3 |
35.1 |
||
SD |
1.7 |
10.5 |
0.3 |
0.7 |
3.9 |
||
Minimum |
11 |
71 |
3 |
2 |
16 |
||
Maximum |
40 |
152 |
20 |
17 |
59 |
||
|
Bacterial strains |
||||||
Historical control data of DMSO control |
‑S9 |
|
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli |
Average |
17.5 |
80.6 |
10.7 |
7.5 |
25.9 |
||
SD |
1.2 |
10.6 |
0.8 |
0.7 |
2.6 |
||
Minimum |
9 |
58 |
4 |
2 |
12 |
||
Maximum |
35 |
124 |
21 |
18 |
52 |
||
+S9 |
|
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli |
|
Average |
22.3 |
95.6 |
10.9 |
8.1 |
34.5 |
||
SD |
1.1 |
10.3 |
0.6 |
0.7 |
4.2 |
||
Minimum |
10 |
65 |
3 |
2 |
16 |
||
Maximum |
37 |
146 |
24 |
19 |
58 |
||
|
Bacterial strains |
||||||
Historical control data of Water control |
‑S9 |
|
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli |
Average |
18.6 |
87.0 |
11.1 |
7.9 |
29.8 |
||
SD |
1.9 |
11.5 |
0.8 |
0.5 |
4.7 |
||
Minimum |
10 |
60 |
3 |
2 |
13 |
||
Maximum |
31 |
120 |
24 |
17 |
55 |
||
+S9 |
|
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli |
|
Average |
23.6 |
105.0 |
11.3 |
8.1 |
36.8 |
||
SD |
1.8 |
11.7 |
0.7 |
0.6 |
4.0 |
||
Minimum |
13 |
76 |
5 |
3 |
18 |
||
Maximum |
41 |
148 |
19 |
17 |
63 |
||
|
Bacterial strains |
||||||
Historical control data of positive controls |
‑S9 |
|
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli |
Average |
364.6 |
1095.3 |
987.7 |
564.4 |
911.6 |
||
SD |
111.2 |
197.3 |
119.3 |
73.8 |
112.8 |
||
Minimum |
182 |
543 |
409 |
137 |
361 |
||
Maximum |
844 |
2200 |
2123 |
2265 |
1995 |
||
+S9 |
|
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli |
|
Average |
1419.2 |
1580.8 |
168.2 |
148.2 |
203.3 |
||
SD |
249.7 |
337.3 |
22.0 |
16.3 |
5.3 |
||
Minimum |
281 |
688 |
93 |
71 |
132 |
||
Maximum |
3421 |
3333 |
349 |
367 |
364 |
Applicant's summary and conclusion
- Conclusions:
- The test item Ammonium formate was tested with regard to its potential mutagenic activity using the Bacterial Reverse Mutation Assay. No biologically relevant increases were observed in the number of revertant colonies in any of the five tester strains following treatment with Ammonium Formate at any concentration levels, either in the presence or absence of S9 Mix in the performed experiments.
Based on the results obtained under the experimental conditions applied, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
In conclusion, the test item Ammonium formate has no mutagenic activity in the bacterial tester strains under the test conditions used in this study. - Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (adopted 21 July 1997), Salmonella typhimurium strains TA97a, TA98, TA100, TA102, TA1535 and the Escherichia coli strain WP2 uvrA were exposed to Ammonium Formate dissolved in ultrapure water in concentrations of 0 (control), 5.0, 16, 50, 160, 500, 1600, and 5000 µg/plate in all strains in the absence and presence of mammalian metabolic activation (rat liver S9 mix). The assay was performed using the plate incorporation method for the initial mutation test and the pre-incubation method for the confirmatory mutation test.
The test substance was tested up to the maximum concentration of 5000 µg/plate as recommended by the guideline. No cytotoxic effects were noted in all strains in the presence and absence of metabolic activation. The positive controls induced the appropriate responses (more than 3-fold increase of revertants) in the corresponding strains. The mean numbers of revertant colonies in the negative controls were within the ranges of the historical control data.
No biologically relevant increases were observed in the number of revertant colonies in any of the five tester strains following treatment with Ammonium Formate at any concentration levels, either in the presence or absence of S9 Mix in the performed experiments. Based on the results obtained under the experimental conditions applied, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
In conclusion, the test item Ammonium Formate has no mutagenic activity in the bacterial tester strains under the test conditions used in this study.
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