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EC number: 226-214-6 | CAS number: 5328-37-0
- 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 β 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- August 19, 2017 - October 19, 2018
- 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:
- 1997-07-21
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008-05-30
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- 1998-08
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guideline S2 (R1): Genotoxicity testing and data interpretation for pharmaceuticals intended for human use
- Version / remarks:
- 2012-06
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- L-arabinose
- EC Number:
- 226-214-6
- EC Name:
- L-arabinose
- Cas Number:
- 5328-37-0
- Molecular formula:
- C5H10O5
- IUPAC Name:
- L-arabinose
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: AD16081001
- Expiration date of the batch: 2019-08-09
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: Stable under ambient conditions
Method
- Target gene:
- his/trp
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- WP2 uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix of Phenobarbital (PB) and Ξ²-naphthoflavone (BNF) induced rat liver
- Test concentrations with justification for top dose:
- Selection of the concentrations was done on the basis of a solubility test and a concentration range finding test (Informatory Toxicity Test). The highest dose was 5000 ΞΌg test item/plate in absence and in the presence of exogenous metabolic activation (Β±S9 Mix) in the final treatment mixture under the actual conditions of the test at the start of the experiment for all test strains used. Six concentrations of the test item were tested each separated by approximately β10 factor in the main studies. The test concentrations were: Β±S9 Mix: 5000; 1600; 500; 160; 50 and 16 ΞΌg/plate.
- Vehicle / solvent:
- - Solvent used: ultrapure water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-1,2-phenylene-diamine (NPD) [
- Remarks:
- TA98: 4 Β΅g/plate, without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100, TA1535: 2 Β΅g/plate, without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537: 50 Β΅g/plate, without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- E.coli WP2 uvrA: 2 Β΅L/plate, without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- all Salmonella strains: 2 Β΅g/plate, with S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- E.coli strain: 50 Β΅g/plate, with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
DURATION
- Preincubation period: 20 min at 37 Β°C
- Exposure duration: 48 h at 37 Β°C
SELECTION AGENT : Biotin overlay agar (for Salmonella typhimurium strains), Tryptophan overlay agar (for Escherichia coli strain)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method,other: The viability of each testing culture was determined by plating 0.1 mL of the 10E-5, 10E-6, 10E-7 and 10E-8 dilutions of cultures on nutrient agar plates. The viable cell number of the cultures was determined by plating experiments and manual counting. - Evaluation criteria:
- The colony numbers on the untreated, vehicle and positive controls and the test item treated plates were determined (counted manually, evaluated by unaided eye), the mean values, standard deviations and the mutation rates were calculated.
Mutation Rate = Mean revertants at the test item (or control*) treatments / mean revertants of vehicle control
* untreated, vehicle or positive control
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
- 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.
According to the guidelines, the biological relevance of the results was the criterion for the interpretation of results, a statistical evaluation of the results was not regarded as necessary.
Criteria for a Negative Response:
A test item is considered non-mutagenic in this bacterial reverse mutation assay 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.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- 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 nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Summary Table of the Results of the Initial Mutation Test
Concentrations (ΞΌg/plate)
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
Escherichia coli WP2 uvrA |
|||||||||||||||
-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 |
19.7 |
1.09 |
26.0 |
1.26 |
87.7 |
1.00 |
91.7 |
1.01 |
9.0 |
0.79 |
13.3 |
0.95 |
8.3 |
0.93 |
9.0 |
1.13 |
32.7 |
0.91 |
46.7 |
0.85 |
DMSO Control |
16.0 |
1.00 |
21.3 |
1.00 |
β |
β |
94.3 |
1.00 |
β |
β |
14.7 |
1.00 |
6.0 |
1.00 |
7.3 |
1.00 |
β |
β |
43.7 |
1.00 |
Ultrapure Water Control |
18.0 |
1.00 |
20.7 |
1.00 |
87.3 |
1.00 |
90.7 |
1.00 |
11.3 |
1.00 |
14.0 |
1.00 |
9.0 |
1.00 |
8.0 |
1.00 |
36.0 |
1.00 |
54.7 |
1.00 |
5000 |
28.0 |
1.56 |
28.3 |
1.37 |
90.0 |
1.03 |
110.3 |
1.22 |
13.3 |
1.18 |
12.0 |
0.86 |
6.3 |
0.70 |
7.0 |
0.88 |
47.0 |
1.31 |
54.3 |
0.99 |
1600 |
30.0 |
1.67 |
29.3 |
1.42 |
79.0 |
0.90 |
104.3 |
1.15 |
13.0 |
1.15 |
11.0 |
0.79 |
7.7 |
0.85 |
9.0 |
1.13 |
46.7 |
1.30 |
57.3 |
1.05 |
500 |
21.3 |
1.19 |
19.3 |
0.94 |
90.0 |
1.03 |
108.7 |
1.20 |
16.0 |
1.41 |
14.0 |
1.00 |
10.0 |
1.11 |
9.3 |
1.17 |
50.0 |
1.39 |
55.3 |
1.01 |
160 |
28.3 |
1.57 |
23.0 |
1.11 |
77.7 |
0.89 |
101.3 |
1.12 |
13.7 |
1.21 |
11.7 |
0.83 |
8.0 |
0.89 |
7.0 |
0.88 |
41.0 |
1.14 |
42.0 |
0.77 |
50 |
24.3 |
1.35 |
20.0 |
0.97 |
73.7 |
0.84 |
92.7 |
1.02 |
8.7 |
0.76 |
13.3 |
0.95 |
8.3 |
0.93 |
8.0 |
1.00 |
40.0 |
1.11 |
49.0 |
0.90 |
16 |
23.3 |
1.30 |
24.0 |
1.16 |
86.3 |
0.99 |
96.0 |
1.06 |
10.3 |
0.91 |
12.0 |
0.86 |
10.0 |
1.11 |
8.0 |
1.00 |
44.3 |
1.23 |
43.3 |
0.79 |
NPD (4 ΞΌg) |
357.3 |
22.33 |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
SAZ (2 ΞΌg) |
β |
β |
β |
β |
933.3 |
10.69 |
β |
β |
533.3 |
47.06 |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
9AA (50 ΞΌg) |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
758.0 |
126.33 |
β |
β |
β |
β |
β |
β |
MMS (2 ΞΌL) |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
821.3 |
22.81 |
β |
β |
2AA (2 ΞΌg) |
β |
β |
1828.0 |
85.69 |
β |
β |
1493.3 |
15.83 |
β |
β |
237.3 |
16.18 |
β |
β |
153.3 |
20.91 |
β |
β |
β |
β |
2AA (50 ΞΌg) |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
193.7 |
4.44 |
MR: Mutation Rate; NPD: 4-Nitro-1,2-phenylenediamine; SAZ: Sodium azide; 9AA: 9-Aminoacridine; MMS: Methyl methanesulfonate; 2AA: 2-aminoanthracene
Remarks: Ultrapure water was applied as vehicle of the test item and the positive control substances: SAZ and MMS; and the DMSO was applied as vehicle for positive control substances: NPD, 9AA and 2AA. The mutation rate of the test item, SAZ, MMS and untreated control is given referring to the ultrapure water; the mutation rate of NPD, 9AA and 2AA is given referring to DMSO.
Table 2: Summary Table of the Results of the Confirmatory Mutation Test
Concentrations (ΞΌg/plate)
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
Escherichia coli WP2 uvrA |
|||||||||||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|||||||||||
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 |
27.3 |
1.08 |
29.0 |
1.19 |
92.7 |
1.06 |
92.0 |
0.88 |
11.0 |
1.00 |
11.0 |
0.92 |
10.3 |
1.19 |
9.0 |
1.13 |
17.0 |
0.46 |
39.3 |
0.84 |
DMSO Control |
23.0 |
1.00 |
22.7 |
1.00 |
β |
β |
94.3 |
1.00 |
β |
β |
13.0 |
1.00 |
7.3 |
1.00 |
6.3 |
1.00 |
β |
β |
38.7 |
1.00 |
Ultrapure Water Control |
25.3 |
1.00 |
24.3 |
1.00 |
87.3 |
1.00 |
104.0 |
1.00 |
11.0 |
1.00 |
12.0 |
1.00 |
8.7 |
1.00 |
8.0 |
1.00 |
36.7 |
1.00 |
46.7 |
1.00 |
5000 |
29.0 |
1.14 |
19.3 |
0.79 |
83.7 |
0.96 |
94.3 |
0.91 |
12.3 |
1.12 |
9.0 |
0.75 |
6.7 |
0.77 |
9.0 |
1.13 |
39.7 |
1.08 |
46.7 |
1.00 |
1600 |
28.3 |
1.12 |
22.3 |
0.92 |
82.3 |
0.94 |
101.0 |
0.97 |
9.3 |
0.85 |
10.0 |
0.83 |
6.7 |
0.77 |
9.7 |
1.21 |
42.7 |
1.16 |
39.3 |
0.84 |
500 |
31.0 |
1.22 |
23.0 |
0.95 |
81.7 |
0.94 |
110.3 |
1.06 |
10.7 |
0.97 |
8.7 |
0.72 |
9.0 |
1.04 |
9.7 |
1.21 |
39.0 |
1.06 |
41.0 |
0.88 |
160 |
25.0 |
0.99 |
27.7 |
1.14 |
84.3 |
0.97 |
98.0 |
0.94 |
9.3 |
0.85 |
11.0 |
0.92 |
7.7 |
0.88 |
9.0 |
1.13 |
39.3 |
1.07 |
41.7 |
0.89 |
50 |
27.3 |
1.08 |
17.0 |
0.70 |
84.3 |
0.97 |
108.0 |
1.04 |
8.7 |
0.79 |
11.0 |
0.92 |
10.0 |
1.15 |
7.3 |
0.92 |
45.0 |
1.23 |
44.0 |
0.94 |
16 |
24.7 |
0.97 |
22.7 |
0.93 |
87.0 |
1.00 |
110.3 |
1.06 |
10.7 |
0.97 |
9.7 |
0.81 |
6.0 |
0.69 |
8.7 |
1.08 |
36.0 |
0.98 |
33.3 |
0.71 |
NPD (4 ΞΌg) |
253.3 |
11.01 |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
SAZ (2 ΞΌg) |
β |
β |
β |
β |
797.3 |
9.13 |
β |
β |
509.3 |
46.30 |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
9AA (50 ΞΌg) |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
528.0 |
72.00 |
β |
β |
β |
β |
β |
β |
MMS (2 ΞΌL) |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
741.3 |
20.22 |
β |
β |
2AA (2 ΞΌg) |
β |
β |
1532.0 |
67.59 |
β |
β |
2826.7 |
29.96 |
β |
β |
164.0 |
12.62 |
β |
β |
121.7 |
19.21 |
β |
β |
β |
β |
2AA (50 ΞΌg) |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
β |
243.7 |
6.30 |
MR: Mutation Rate; NPD: 4-Nitro-1,2-phenylenediamine; SAZ: Sodium azide; 9AA: 9-Aminoacridine; MMS: Methyl methanesulfonate; 2AA: 2-aminoanthracene
Remarks: Ultrapure water was applied as vehicle of the test item and the positive control substances: SAZ and MMS; and the DMSO was applied as vehicle for positive control substances: NPD, 9AA and 2AA. The mutation rate of the test item, SAZ, MMS and untreated control is given referring to the ultrapure water; the mutation rate of NPD, 9AA and 2AA is given referring to DMSO.
Applicant's summary and conclusion
- Conclusions:
- In an in vitro bacterial reverse mutation assay (Ames test) according to OECD TG 471, the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the tester strains used. Therefore, L-Arabinose is considered non-mutagenic.
- Executive summary:
Five bacterial strains, Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA were used to investigate the mutagenic potential of the test item in two independent experiments, in a plate incorporation test (experiment I, Initial Mutation Test) and in a pre-incubation test (experiment II, Confirmatory Mutation Test) according to OECD Guideline 471. Each assay was conducted with and without metabolic activation (Β±S9 Mix). The concentrations, including the controls, were tested in triplicate (positive and negative controls were run concurrently).
In the Initial Mutation Test nearly all of the obtained higher revertant colony numbers (higher than the revertant colony numbers of the vehicle control) remained within the corresponding historical control data ranges. In the case of E. coli WP2 uvrA, at 500 ΞΌg/plate (-S9 Mix), the higher revertant colony numbers were above the corresponding historical control data range; however this increase was unique without any tendency and remained within the biological variability range of the applied test system.
All of the obtained increases were far below the biologically relevant threshold for being positive and were considered as reflecting the biological variability of the test system.
In the Initial Mutation Test, inhibitory effect of the test item on bacterial growth was not observed. All of the noticed lower revertant colony numbers (when compared to the revertant colony numbers of the corresponding vehicle control) remained in the range of the biological variability of the applied test system and the background lawn development was not affected in any case. The reported data of this mutagenicity assay shows, that under the experimental conditions reported, the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the tester strains used. Therefore, L-Arabinose is considered non-mutagenic in this bacterial reverse mutation assay.
The test item concentrations in experiment II were the same as already tested in the Initial Mutation Test. In the Confirmatory Mutation Test all of the noticed increased revertant colony numbers remained in the corresponding historical control data ranges of the ultrapure water vehicle control, and were without any biological significance. In the Confirmatory Mutation Test inhibitory effect of the test item, similarly to the results of the first experiment was not observed.
In the performed experiments the revertant colony numbers of the untreated and dimethyl sulfoxide (DMSO) control plates in the different experimental phases were slightly higher or lower than the ultrapure water vehicle control plates. The higher or lower revertant counts of these controls remained in the historical control data ranges. The reference mutagen treatments (positive controls) showed the expected, biological relevant increases in induced revertant colonies in all experimental phases, in all tester strains. No substantial increases were observed in revertant colony numbers of any of the five tester strains following treatment with L-Arabinose at any concentration level, either in the presence or absence of metabolic activation (S9 Mix) in the performed experiments. Sporadic increases in revertant colony numbers compared to the vehicle control values were observed in both independently performed main experiments; however, there was no tendency of higher mutation rates with increasing concentrations beyond the generally acknowledged border of biological relevance in the performed experiments.
The highest revertant colony number increase was observed in the Initial Mutation Test (Plate Incorporation Test), in the case of S. typhimurium TA98, at 1600 ΞΌg/plate (-S9 Mix). The mutation rate was: 1.67*. The higher (in comparison with the revertant colony numbers of the vehicle control) revertant colony counts remained in the corresponding ultrapure water historical control data range and far below the genotoxicological threshold for being positive.
* Mutation rate (MR): The mutation rate is the quotient of the mean revertant of test item treatment and the mean revertant of the vehicle control. In the case of Salmonella typhimurium TA98 a biologically relevant increase (positive result) is when the number of reversions is at least three times higher than the reversion rate of the vehicle control (Mutation rate β₯ 3.00).
Signs of cytotoxicity were not observed in either tested strains with and/or without metabolic activation. No precipitation of the test item was observed on the plates in the examined bacterial strains at any examined concentration level (Β±S9 Mix) throughout the study.
The reported data of this mutagenicity assay shows, that under the experimental conditions reported, the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the tester strains used. Therefore, L-Arabinose is considered non-mutagenic in this bacterial reverse mutation assay.
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