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EC number: 205-126-1 | CAS number: 134-03-2
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenic Evaluation of Compound. FDA 75-64 Sodium Ascorbate USP, FCC
- Author:
- Litton Bionetics, Inc, Kensington, Md
- Year:
- 1 976
- Bibliographic source:
- PB-266 896
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- yes
- Remarks:
- only three dose levels and only two plates per dose level were tested, no induction of the liver homogenate
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ascorbic acid
- EC Number:
- 200-066-2
- EC Name:
- Ascorbic acid
- Cas Number:
- 50-81-7
- Molecular formula:
- C6H8O6
- IUPAC Name:
- 5-(1,2-dihydroxyethyl)-3,4-dihydroxyfuran-2(5H)-one (non-preferred name)
Constituent 1
Method
- Target gene:
- various genes in the histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver homogenate prepared from mouse, rat and monkey
- Test concentrations with justification for top dose:
- 0.075, 0.15 and 0. 3 % (w/v)
Based on cytotoxicity data.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water or saline
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: methylnitrosoguanidine
- Remarks:
- (MNNG) without metabolic actication, TA1535, TA100, 2 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylsulfoxide (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- (NF), without metabolic activation, TA1538, TA98, 100 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water or saline
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: quinacrine mustard
- Remarks:
- (QM), without metabolic activation, TA1537, 20 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylsulfoxide (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- (ANTH), with metabolic activation, TA1535, TA100, 100 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 8-aminoquinoline
- Remarks:
- (AMQ), with metabolic activation, TA1537, 100 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Remarks:
- (AAF), with metabolic activation, TA1538, TA98, 100 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding: 10E8 cells
DURATION
- Exposure duration: 48 - 72 hours in the dark
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- The test chemical was tested for toxicity against specific indicator strains over a range of doses to determine the 50% survival dose. Bacteria were tested in phosphate buffer, pH 7.4, for one hour at 37°C on a shaker. The 50% survival concentrations and the 1/4 and 1/2 50% doses were calculated. If no toxicity was obtained for the chemical with a given strain, then a maximum dose of S% (w/v) was used. - Evaluation criteria:
- 1. Strains TA1535, TA1537, and TA1538
If the solvent control value is within the normal range, a chemical which produces a positive dose response over three concentrations with the lowest increase equal to twice the solvent control value is considered to be mutagenic.
2. Strains TA-98 and TA-100
If the solvent control value is within the normal range, a chemical which produces a positive dose response over three concentrations with the highest increase equal to twice the solvent control value for TA100 and two to three times the solvent control value for strains TA98 is considered to be mutagenic. For these strains, the dose response increase should start at approximately the solvent control value.
3. Pattern
Because TA1535 and TA100 were both derived from the same parental strain (G-46) and because TA1538 and TA98 were both derived from the same parental strain (D3052), there is a built-in redundancy in the microbial assay. In general the two strains of a set respond to the same mutagen and such a pattern is sought. It is also anticipated that if a given strain, e.g. TA1537, responds to a mutagen in nonactivation tests it will generally do so in activation tests. (The converse of this relationship is not expected.) While similar response patterns are not required for all mutagens, they can be used to enhance tha reliability of an evaluation decision.
4. Reproducibility
If a chemical produces a response in a single test which cannot be reproduced in one or more additional runs, the initial positive test data loses significance. The preceding criteria are not absolute and other extenuating factors may enter into a final evaluation decision. However, these criteria are applied to the majority of situations and are presented to aid those individuals not familiär with this procedure. As the data base is increased, the criteria for evaluation can be more firmly established. - Statistics:
- none
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
- 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
- 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
- Positive controls validity:
- not 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:
- not valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Table: Summary of test results - plate incorporation tests
Test |
Species |
Tissue |
Revertants per plate |
|||||||||
TA-1535 |
TA-1537 |
TA-1538 |
TA-98 |
TA-100 |
||||||||
Plate 1 |
Plate 2 |
Plate 1 |
Plate 2 |
Plate 1 |
Plate 2 |
Plate 1 |
Plate 2 |
Plate 1 |
Plate 2 |
|||
1. Non-activation |
||||||||||||
Solvent control |
-- |
-- |
31 |
23 |
31 |
19 |
19 |
18 |
22 |
21 |
201 |
248 |
Positive control |
-- |
-- |
>1000 |
>1000 |
895 |
461 |
>1000 |
>1000 |
>1000 |
>1000 |
>1000 |
>1000 |
Test 0.30000% |
-- |
-- |
34 |
22 |
26 |
26 |
9 |
26 |
40 |
22 |
291 |
196 |
0.15000 % |
-- |
-- |
23 |
21 |
40 |
30 |
16 |
12 |
30 |
33 |
266 |
212 |
0.07500 % |
-- |
-- |
28 |
36 |
16 |
16 |
19 |
21 |
36 |
29 |
247 |
245 |
2. Activation |
||||||||||||
Solvent control |
Mouse |
Liver |
25 |
40 |
20 |
12 |
22 |
23 |
24 |
19 |
111 |
123 |
|
Rat |
Liver |
20 |
20 |
14 |
11 |
32 |
28 |
40 |
59 |
89 |
77 |
|
Monkey |
Liver |
16 |
41 |
12 |
6 |
22 |
36 |
51 |
60 |
57 |
71 |
Positive control |
Mouse |
Liver |
202 |
154 |
303 |
516 |
>1000 |
>1000 |
167 |
129 |
123 |
100 |
|
Rat |
Liver |
94 |
91 |
>1000 |
127 |
462 |
500 |
239 |
173 |
154 |
181 |
|
Monkey |
Liver |
513 |
375 |
80 |
119 |
>1000 |
>1000 |
142 |
183 |
167 |
285 |
Test 0.30000% |
Mouse |
Liver |
21 |
26 |
25 |
15 |
21 |
20 |
34 |
30 |
150 |
160 |
0.15000 % |
Mouse |
Liver |
27 |
35 |
26 |
17 |
19 |
21 |
33 |
36 |
141 |
151 |
0.07500 % |
Mouse |
Liver |
39 |
54 |
15 |
20 |
20 |
17 |
31 |
42 |
152 |
156 |
Test 0.30000% |
Rat |
Liver |
15 |
19 |
12 |
14 |
17 |
10 |
65 |
65 |
94 |
101 |
0.15000 % |
Rat |
Liver |
18 |
18 |
6 |
19 |
13 |
18 |
64 |
65 |
84 |
86 |
0.07500 % |
Rat |
Liver |
16 |
23 |
13 |
8 |
30 |
11 |
58 |
52 |
66 |
78 |
Test 0.30000% |
Monkey |
Liver |
37 |
30 |
9 |
13 |
24 |
18 |
55 |
34 |
57 |
57 |
0.15000 % |
Monkey |
Liver |
31 |
40 |
13 |
10 |
21 |
18 |
62 |
33 |
58 |
78 |
0.07500 % |
Monkey |
Liver |
25 |
36 |
14 |
8 |
21 |
13 |
61 |
43 |
57 |
67 |
Applicant's summary and conclusion
- Conclusions:
- The test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the tester strains used. Therefore, the substance is considered non-mutagenic in this bacterial reverse mutation assay.
- Executive summary:
The genetic toxicity of ascorbic acid was tested in-vitro using bacteria (S. typhimurium, strains TA 98; TA100, TA1535, TA1537 and TA1538) with metabolic activation (S-9 from mouse, rat and monkey) using the plate incorporation method. The test substance (maximum dose 0.3 % (w/v)/plate) was incubated at 37°C for 48 to 72 hours. The number of his-independent colonies were counted thereafter. Ascorbic acid was negative in this bacterial reverse mutation test (Litton Bionics, 1976).
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