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EC number: 203-536-5 | CAS number: 107-95-9
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 December 2000 - 30 March 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- : OECD GLP (1997)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- β-alanine
- EC Number:
- 203-536-5
- EC Name:
- β-alanine
- Cas Number:
- 107-95-9
- Molecular formula:
- C3H7NO2
- IUPAC Name:
- β-alanine
- Reference substance name:
- 3-aminopropanoic acid
- IUPAC Name:
- 3-aminopropanoic acid
- Details on test material:
- - Physical state: Orthorhombic crystal
- Purity: 98.2 %
- Impurities: No data
- Lot/batch No.: GH01
- Manufacuture: Tokyo Chemical Industry Co., Ltd.
- Stability under test conditions: Stable during the test period (confirmed by other related test)
- Storage condition of test material: in cool, light-blocking and air-tight conditions
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver, induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- - Dose determination test: 5, 10, 50, 100, 500, 1000, and 5000 μg/plate
- Mutagenicity test: 312.5, 625, 1250, 2500, and 5000 μg/plate
- Confirmation test: 312.5, 625, 1250, 2500, and 5000 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Distilled water for injection (Lot No. 00603D, Japanese Pharmacopeia, Fuso Pharmaceutical Industries, Ltd.)
- Justification for choice of solvent/vehicle: The test substance was soluble in water at 55.5 g/dL, and stable. Therefore distilled water for injection was selected as a vehicle.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- : Distilled water for injection (Lot No. 00603D, Japanese Pharmacopeia, Fuso Pharmaceutical Industries, Ltd.)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2) (Lot No. CKQ1402, Purity: 99.0%, Wako Pure Chemical Industries, Ltd.)
- Remarks:
- without S9 (S. typhimurium TA98, TA100; E. coli WP2 uvr A)
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 (S. typhimurium TA1535)
Migrated to IUCLID6: (SA) (Lot No. ELJ6565, Purity: 99.7%, Wako Pure Chemical Industries, Ltd.)
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 (S. typhimurium TA1537)
Migrated to IUCLID6: (9-AA) (Lot No. 106F06681, Purity: 97%, SIGMA CHEMICAL Co., Ltd.)
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2-AA) (Lot No. ELJ6826, Purity: 97.4%, Wako Pure Chemical Industries, Ltd.)
- Remarks:
- with S9 (all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION
- Dose determination test and mutagenicity test: plate incorporation method
- Confirmation test: preincubation method
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
NUMBER OF PLATES
- Dose determination test: 2 plates/dose
- Mutagenicity test and confirmation test: 3 plates/dose
DETERMINATION OF CYTOTOXICITY
- Method: Growth inhibition of the bacterial background lawn was microscopically observed in each plate comparing to the solvent control.
OTHER EXAMINATIONS
- Precipitation of the test substance was microscopically observed.
- Colony counting for the solvent controls and the test substance groups was conducted with naked eyes, and for the positive control groups was conducted with a colony counter (Olympus, OL-502A, Yoshikawa Kogyo Co., Ltd.). In use of colony counter, the number of the bacterial colony was counted three times per plate and calculated the average for each plate. - Evaluation criteria:
- A test substance was judged to be mutagenic (+) when a dose-related increase in the number of revertant colony was observed, the number of revertant colonies per plate in the test substance group was more than twice that of the negative control (solvent control) and when a reproducibility of test result was observed, or when a evident increase in the number of revertant colony was observed at one dose and a reproducibility of the test result was observed. A test substance for which the results do not meet the above criteria is judged to be non-mutagenic (-).
Growth in hibition was detected by increasing in colonies diameter or clearing of the background lawn of tester strains as compared with that of negative control. - Statistics:
- A statistical analysis was not performed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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:
- not examined
- Positive controls validity:
- valid
- 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:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- DOSE DETERMINATION TEST (PLATE INCORPORATION METHOD)
Results are shown in Table 1.
Neither precipitation of the test substance nor bacterial growth inhibition by the test substance was observed in any dose groups of the test substance. Therefore five concentration of the test substance was set at 312.5 to 5000 μg/plate with a common ration of 2 in mutagenicity test.
MUTAGENICITY TEST (PLATE INCORPORATION METHOD)
Results are shown in Table 2.
The test substance did not show any significant dose-related increase in the number of revertant colonies to at least twice as many as that of the solvent control in any test strains with or without metabolic activation.
Neither precipitation of the test substance nor bacterial growth inhibition by the test substance was observed in any dose groups of the test substance.
CONFIRMATION TEST (PREINCUBATION METHOD)
Results are shown in Table 3.
The test substance showed similar findings to the mutagenicity test. Therefore, the reproducibility of test results were confirmed.
Neither precipitation of the test substance nor bacterial growth inhibition by the test substance was observed in any dose groups of the test substance.
VALIDITY OF THE TEST
The number of the revertant colonies in the positive control group showed evident increase comparing to that of the solvent control at any tests.
The number of revertant colonies in both solvent control and positive control were within the expected range (mean ± 2S.D.) to the background data in this laboratory. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Reverse mutation test of beta-alanine in S.typhimurium and E.coli (Dose determination test)
| With (+) or without (-) S9 mix |
Test substance concentration (μg/plate) |
Number of revertants (number of colonies/plate)a) | ||||
| Base-pair substitution type | Frameshift type | |||||
| TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | ||
| S9 mix (-) |
Solvent control | 129 126 (128) |
11 18 (15) |
41 27 (34) |
25 31 (28) |
11 10 (11) |
| 5 | 133 134 (134) |
15 21 (18) |
24 33 (29) |
26 29 (28) |
16 13 (15) |
|
| 10 | 137 137 (137) |
8 9 (9) |
25 47 (36) |
37 37 (37) |
15 12 (14) |
|
| 50 | 167 150 (159) |
14 12 (13) |
35 34 (35) |
22 29 (26) |
15 15 (15) |
|
| 100 | 124 122 (123) |
11 11 (11) |
47 32 (40) |
34 38 (36) |
9 15 (12) |
|
| 500 | 135 136 (136) |
9 16 (13) |
31 43 (37) |
32 29 (31) |
8 7 (8) |
|
| 1000 | 111 118 (115) |
12 12 (12) |
35 32 (34) |
31 23 (27) |
10 12 (11) |
|
| 5000 | 111 127 (119) |
8 11 (10) |
39 40 (40) |
26 27 (27) |
13 12 (13) |
|
| S9 mix (+) |
Solvent control | 156 145 (151) |
14 18 (16) |
42 49 (46) |
42 42 (42) |
11 17 (14) |
| 5 | 162 155 (159) |
10 14 (12) |
28 31 (30) |
41 45 (43) |
8 7 (8) |
|
| 10 | 160 162 (161) |
14 15 (15) |
40 40 (40) |
42 26 (34) |
13 12 (13) |
|
| 50 | 152 145 (149) |
16 18 (17) |
45 47 (46) |
42 38 (40) |
13 14 (14) |
|
| 100 | 160 155 (158) |
17 12 (15) |
56 54 (55) |
42 37 (40) |
13 18 (16) |
|
| 500 | 135 150 (143) |
15 7 (11) |
47 37 (42) |
44 44 (44) |
21 17 (19) |
|
| 1000 | 123 147 (135) |
10 18 (14) |
35 40 (38) |
46 43 (45) |
18 12 (15) |
|
| 5000 | 114 119 (117) |
13 25 (19) |
39 41 (40) |
35 37 (36) |
13 11 (12) |
|
| Positive control not requiring S9 mix |
Name | AF-2 | SA | AF-2 | AF-2 | 9-AA |
| Concentration (μg/plate) | 0.01 | 0.5 | 0.01 | 0.1 | 80 | |
| Number of colonies/plate | 470 532 (501) |
556 529 (543) |
268 242 (255) |
477 536 (507) |
498 544 (521) |
|
| Positive control requiring S9 mix |
Name | 2-AA | 2-AA | 2-AA | 2-AA | 2-AA |
| Concentration (μg/plate) | 1 | 2 | 10 | 0.5 | 2 | |
| Number of colonies/plate | 920 1000 (960) |
230 251 (241) |
852 913 (883) |
603 616 (610) |
230 269 (250) |
|
a): The average number of colonies in each concentration.
Solvent: Distilled water for injection
Table 2. Reverse mutation test of beta-alanine in S.typhimurium and E.coli (Mutagenicity test)
| With (+) or without (-) S9 mix |
Test substance concentration (μg/plate) |
Number of revertants (number of colonies/plate)a) | ||||
| Base-pair substitution type | Frameshift type | |||||
| TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | ||
| S9 mix (-) |
Solvent control | 149 142 (149) 156 |
15 7 (12) 15 |
31 24 (27) 25 |
30 30 (31) 32 |
7 9 (9) 12 |
| 312.5 | 127 131 (131) 134 |
16 10 (12) 11 |
26 28 (30) 35 |
39 42 (39) 35 |
12 11 (11) 10 |
|
| 625 | 136 139 (140) 144 |
9 19 (14) 15 |
34 23 (27) 24 |
32 27 (29) 27 |
10 10 (10) 9 |
|
| 1250 | 152 144 (148) 147 |
14 17 (13) 8 |
27 26 (29) 33 |
35 43 (38) 36 |
13 11 (11) 10 |
|
| 2500 | 130 128 (130) 132 |
12 13 (13) 14 |
21 40 (30) 30 |
24 29 (28) 31 |
8 12 (9) 8 |
|
| 5000 | 148 143 (148) 152 |
15 17 (16) 16 |
29 30 (29) 28 |
38 33 (35) 33 |
10 8 (12) 17 |
|
| S9 mix (+) |
Solvent control | 152 162 (154) 149 |
7 19 (14) 16 |
35 31 (32) 29 |
37 34 (40) 49 |
12 9 (13) 17 |
| 312.5 | 147 150 (148) 146 |
19 17 (20) 24 |
37 32 (33) 29 |
48 47 (45) 40 |
17 18 (17) 16 |
|
| 625 | 145 149 (148) 150 |
15 16 (16) 18 |
36 35 (34) 31 |
50 47 (47) 44 |
13 18 (14) 11 |
|
| 1250 | 132 148 (148) 164 |
27 14 (20) 18 |
29 41 (35) 35 |
46 50 (43) 33 |
13 12 (11) 9 |
|
| 2500 | 161 158 (159) 158 |
16 18 (15) 12 |
30 22 (30) 37 |
50 46 (48) 47 |
10 14 (13) 16 |
|
| 5000 | 131 143 (140) 146 |
18 24 (20) 19 |
27 35 (31) 32 |
32 38 (35) 36 |
10 14 (12) 13 |
|
| Positive control not requiring S9 mix |
Name | AF-2 | SA | AF-2 | AF-2 | 9-AA |
| Concentration (μg/plate) | 0.01 | 0.5 | 0.01 | 0.1 | 80 | |
| Number of colonies/plate | 478 509 (506) 532 |
476 561 (520) 524 |
170 225 (200) 206 |
526 462 (500) 513 |
570 578 (569) 560 |
|
| Positive control requiring S9 mix |
Name | 2-AA | 2-AA | 2-AA | 2-AA | 2-AA |
| Concentration (μg/plate) | 1 | 2 | 10 | 0.5 | 2 | |
| Number of colonies/plate | 853 949 (920) 959 |
239 211 (217) 202 |
886 993 (935) 927 |
636 654 (632) 607 |
207 266 (248) 272 |
|
a): The average number of colonies in each concentration.
Solvent: Distilled water for injection
Table 3. Reverse mutation test of beta-alanine in S.typhimurium and E.coli (Confirmation test)
| With (+) or without (-) S9 mix |
Test substance concentration (μg/plate) |
Number of revertants (number of colonies/plate)a) | ||||
| Base-pair substitution type | Frameshift type | |||||
| TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | ||
| S9 mix (-) |
Solvent control | 143 153 (147) 146 |
13 12 (15) 19 |
29 19 (25) 27 |
29 31 (32) 37 |
10 14 (13) 16 |
| 312.5 | 155 138 (148) 151 |
14 12 (12) 10 |
29 32 (30) 29 |
41 44 (41) 38 |
17 14 (16) 17 |
|
| 625 | 143 158 (151) 151 |
17 11 (13) 11 |
38 13 (27) 29 |
30 40 (37) 40 |
14 10 (13) 16 |
|
| 1250 | 155 154 (155) 156 |
12 16 (13) 11 |
28 28 (29) 31 |
29 35 (33) 34 |
14 13 (12) 9 |
|
| 2500 | 143 139 (143) 147 |
13 15 (14) 13 |
23 20 (27) 37 |
34 32 (37) 45 |
15 14 (13) 11 |
|
| 5000 | 133 126 (132) 136 |
17 11 (14) 13 |
20 30 (29) 38 |
25 38 (34) 38 |
9 11 (11) 14 |
|
| S9 mix (+) |
Solvent control | 149 155 (153) 154 |
20 13 (14) 10 |
26 37 (33) 37 |
39 41 (44) 51 |
17 14 (15) 15 |
| 312.5 | 153 154 (155) 158 |
23 16 (18) 15 |
35 36 (33) 29 |
42 46 (45) 47 |
18 15 (17) 18 |
|
| 625 | 148 141 (142) 136 |
14 13 (16) 20 |
36 32 (34) 33 |
43 46 (46) 50 |
18 18 (18) 17 |
|
| 1250 | 149 143 (146) 147 |
16 22 (18) 17 |
30 38 (35) 37 |
42 39 (40) 38 |
10 14 (12) 13 |
|
| 2500 | 148 152 (150) 149 |
10 19 (14) 13 |
38 30 (36) 39 |
41 39 (42) 45 |
19 19 (18) 15 |
|
| 5000 | 145 166 (157) 160 |
26 22 (21) 14 |
31 31 (35) 44 |
41 48 (46) 48 |
10 19 (14) 14 |
|
| Positive control not requiring S9 mix |
Name | AF-2 | SA | AF-2 | AF-2 | 9-AA |
| Concentration (μg/plate) | 0.01 | 0.5 | 0.01 | 0.1 | 80 | |
| Number of colonies/plate | 555 528 (543) 546 |
519 487 (514) 536 |
222 173 (186) 163 |
466 495 (496) 526 |
568 650 (591) 555 |
|
| Positive control requiring S9 mix |
Name | 2-AA | 2-AA | 2-AA | 2-AA | 2-AA |
| Concentration (μg/plate) | 1 | 2 | 10 | 0.5 | 2 | |
| Number of colonies/plate | 1041 988 (997) 962 |
270 241 (261) 272 |
960 904 (945) 970 |
597 566 (585) 593 |
198 224 (219) 236 |
|
a): The average number of colonies in each concentration.
Solvent: Distilled water for injection
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
This bacterial mutation study revealed that beta-alanine was negative with or without metabolic activation system. - Executive summary:
The study was conducted according to OECD TG 471 and 472 under GLP conditions. The mutagenicity of beta-alanine was examined using plate incorporation method inS. typhimurium TA 100, TA 98, TA 1535, TA 1537 and E. coli WP2uvr A, at concentrations up to 5000 μg/plate with or without metabolic activation system. In this study, the number of revertant colonies per plate with beta-alanine was less than twice that of the solvent control. Therefore, beta-alanine is judged to be non-mutagenic.
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