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EC number: 294-620-0 | CAS number: 91744-56-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
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:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium succinate
- EC Number:
- 205-778-7
- EC Name:
- Disodium succinate
- Cas Number:
- 150-90-3
- IUPAC Name:
- disodium succinate
- Details on test material:
- - Name of test material (as cited in study report): succinic acid disodium
- Molecular weight (if other than submission substance): 162.05
- Physical state: white crystalline powder
- Analytical purity: 99.9%
- Stability: due to hygroscopic properties, moisture was increased over time
- Storage condition of test material: at room temperature in a sealed container with silica
Constituent 1
Method
- Target gene:
- his operon (S. typhimurium), trp operon (E. coli)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor-supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- Experiment 1: 0.305, 1.22, 4.88, 19.5, 78.1, 313, 1250 and 5000 µg/plate with and without metabolic activation
Experiment 2: 156, 313, 625, 1250, 2500 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: physiol. saline
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- physiol. saline
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9 mix; 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide (TA100, TA98 and WP2 uvrA), Sodium azide (TA1535) and 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino] acridine 2HCl (TA1537)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- physiol. saline (5000 µg/plate)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9 mix; Benzo[a]pyrene (TA100, TA98, TA1537) and 2-Aminoanthracene (TA1535 and WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- A result was considered positive if the following conditions were met: A two-fold increase in the number of revertants in the test plates compared with the negative control plates and evidence of a dose-response relationship.
- Statistics:
- Mean values were calculated and no statistical analysis was conducted.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No deposition of crystals/precipitate was observed.
RANGE-FINDING/SCREENING STUDIES:
According to the authors, Experiment 1 was a range-finding test. However, under the test conditions described, it can be considered as an independent experiment.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No cytotoxicity (growth inhibition) was observed up to 5000 µg/plate in the presence and absence of metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Results of Experiment 1.
Number of revertant colonies/plate (mean value rounded to the nearest whole numer) |
|||||
EXPERIMENT 1 |
|||||
S9-Mix |
Without |
||||
|
Base-pair substitution type |
Frameshift type |
|||
Test item (µg/plate) |
TA 100 |
TA 1535 |
WPA uvrA |
TA 98 |
TA 1537 |
Physiol. saline |
113 109 113 (112) |
11 15 15 (14) |
28 23 27 (26) |
24 21 20 (22) |
12 12 13 (12) |
0.305 |
113 108 121 (114) |
11 16 11 (13) |
21 24 23 (23) |
20 20 21 (20) |
11 11 15 (12) |
1.22 |
110 102 100 (104) |
16 11 13 (13) |
25 31 23 (26) |
28 24 21 (24) |
11 16 15 (14) |
4.88 |
105 134 114 (118) |
11 15 15 (14) |
25 28 27 (27) |
31 23 21 (25) |
15 16 17 (16) |
19.5 |
100 126 114 (113) |
15 15 15 (15) |
21 27 24 (24) |
21 27 20 (23) |
16 12 12 (13) |
78.1 |
110 101 105 (105) |
9 11 11 (10) |
29 29 25 (28) |
23 20 21 (21) |
15 13 16 (15) |
313 |
104 117 125 (115) |
17 12 16 (15) |
24 23 27 (25) |
23 25 20 (23) |
13 13 11 (12) |
1250 |
112 105 110 (109) |
11 11 11 (11) |
29 25 23 (26) |
21 24 28 (24) |
12 15 16 (14) |
5000 |
106 121 102 (110) |
12 12 11 (12) |
28 27 24 (26) |
21 24 28 (24) |
12 15 16 (14) |
AF-2 (0.01) |
890 815 862 (856) |
- |
132 157 158 (149) |
- |
- |
AF-2 (0.10) |
- |
- |
- |
491 427 409 (442) |
- |
SAZ (0.50) |
- |
359 392 362 (371) |
- |
- |
- |
ICR-191 (1.00) |
- |
- |
- |
- |
1790 1809 1815 (1805) |
S9-Mix |
With |
||||
Test item (µg/plate) |
TA 100 |
TA 1535 |
WPA uvrA |
TA 98 |
TA 1537 |
Physiol. saline |
118 122 118 (119) |
11 13 12 (12) |
36 27 33 (32) |
35 41 33 (36) |
21 16 13 (14) |
0.305 |
113 130 109 (117) |
15 15 11 (14) |
31 27 29 (29) |
35 33 28 (32) |
19 12 12 (14) |
1.22 |
113 104 102 (106) |
12 11 11 (11) |
33 31 31 (32) |
27 31 31 (30) |
16 16 11 (14) |
4.88 |
126 128 134 (129) |
11 15 17 (14) |
25 32 35 (31) |
33 33 33 (33) |
11 16 11 (13) |
19.5 |
113 109 117 (113) |
13 11 12 (12) |
36 35 32 (34) |
37 40 39 (39) |
11 16 16 (14) |
78.1 |
129 120 100 (116) |
11 12 15 (13) |
28 28 31 (29) |
28 37 36 (34) |
16 11 15 (14) |
313 |
113 100 118 (110) |
11 13 16 (13) |
32 27 29 (29) |
33 27 31 (30) |
12 16 13 (14) |
1250 |
136 117 110 (121) |
11 16 12 (13) |
24 24 28 (25) |
33 29 28 (30) |
12 16 17 (15) |
5000 |
113 121 113 (116) |
13 11 17 (14) |
32 31 25 (29) |
36 33 28 (32) |
16 15 17 (16) |
B[a]P (5.00) |
818 811 904 (844) |
- |
- |
241 239 217 (232) |
92 89 80 (87) |
2AA (2.00) |
- |
217 196 206 (206) |
|
- |
- |
2AA (10.0) |
|
|
404 491 411 (435) |
|
|
AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
SAZ: Sodium azide
ICR-191: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino]acridine.2HCl
B[a]P: Benzo[a]pyrene
2AA: 2-Aminoanthracene
Table 2. Results of Experiment 2.
Number of revertant colonies/plate (mean value rounded to the nearest whole numer) |
|||||
EXPERIMENT 2 |
|||||
S9-Mix |
Without |
||||
|
Base-pair substitution type |
Frameshift type |
|||
Test item (µg/plate) |
TA 100 |
TA 1535 |
WPA uvrA |
TA 98 |
TA 1537 |
Physiol. saline |
118 114 101 (111) |
11 11 16 (13) |
28 27 24 (26) |
21 24 20 (22) |
15 11 11 (12) |
156 |
109 104 113 (109) |
15 11 15 (14) |
25 21 25 (24) |
21 21 21 (21) |
11 12 15 (13) |
313 |
114 112 109 (112) |
13 12 13 (13) |
29 24 21 (25) |
19 19 23 (20) |
12 13 11 (12) |
625 |
108 104 106 (106) |
11 13 12 (12) |
29 21 25 (25) |
20 19 21 (20) |
11 15 12 (13) |
1250 |
112 110 119 (113) |
12 12 16 (13) |
25 28 23 (25) |
21 21 23 (22) |
13 12 17 (14) |
2500 |
105 109 109 (108) |
13 13 11 (12) |
25 20 27 (24) |
20 25 24 (23) |
16 11 16 (14) |
5000 |
108 118 106 (110) |
15 13 15 (14) |
31 24 24 (26) |
25 29 20 (25) |
16 12 13 (14) |
AF-2 (0.01) |
853 859 819 (844) |
- |
145 145 168 (153) |
- |
- |
AF-2 (0.10) |
- |
- |
- |
487 485 468 (480) |
- |
SAZ (0.50) |
- |
384 408 399 (397) |
- |
- |
- |
ICR-191 (1.00) |
- |
- |
- |
- |
1803 1810 1825 (1813) |
S9-Mix |
With |
||||
Test item (µg/plate) |
TA 100 |
TA 1535 |
WPA uvrA |
TA 98 |
TA 1537 |
Physiol. saline |
112 102 124 (113) |
17 11 12 (13) |
24 27 24 (25) |
35 33 31 (33) |
12 16 16 (15) |
156 |
121 130 109 (120) |
16 12 12 (13) |
29 29 25 (28) |
32 35 39 (35) |
17 13 12 (14) |
313 |
101 110 128 (113) |
11 15 11 (12) |
21 25 25 (24) |
27 31 39 (32) |
19 13 13 (15) |
625 |
121 112 124 (119) |
12 19 13 (15) |
28 23 27 (26) |
33 29 28 (30) |
12 16 12 (13) |
1250 |
114 109 134 (119) |
12 13 11 (12) |
25 24 29 (26) |
36 37 32 (35) |
11 12 16 (13) |
2500 |
125 100 120 (115) |
11 13 11 (12) |
29 29 25 (28) |
33 35 28 (32) |
17 13 13 (14) |
5000 |
132 101 104 (112) |
12 13 12 (12) |
20 29 24 (24) |
27 31 35 (31) |
16 19 13 (16) |
B[a]P (5.00) |
907 815 894 (872) |
- |
- |
250 251 235 (245) |
97 88 88 (91) |
2AA (2.00) |
- |
157 170 196 (174) |
- |
- |
- |
2AA (10.0) |
- |
- |
485 402 398 (428) |
- |
- |
AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
SAZ: Sodium azide
ICR-191: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino]acridine.2HCl
B[a]P: Benzo[a]pyrene
2AA: 2-Aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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