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EC number: 246-857-6 | CAS number: 25333-42-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Original language of the report in Japanese
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (R)-quinuclidin-3-ol
- EC Number:
- 246-857-6
- EC Name:
- (R)-quinuclidin-3-ol
- Cas Number:
- 25333-42-0
- Molecular formula:
- C7H13NO
- IUPAC Name:
- quinuclidin-3-ol
- Test material form:
- solid: crystalline
Constituent 1
Method
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:
- S9-mix
- Test concentrations with justification for top dose:
- 1.2, 4.9, 20, 78, 313, 1250, 5000 ug/L
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: see table 1 in results
- Evaluation criteria:
- The test substance was judged as mutagenic (positive) when the number of revertant colonies (mean) increased dose-dependently more than twice of the mean value of the negative control in any of the tester strains either with or without S9 mix, and reproducibility was noted in the increase.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 2500 and 5000 ug/L
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 2500 and 5000 ug/L
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 2500 and 5000 ug/L
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 2500 and 5000 ug/L
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 2500 and 5000 ug/L
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Test results - Experiment 1
| Metabolic activation | test substance conc. (ug/plate) |
No of reverse mutations (No. of colonies/plate) |
||||
| Base pair substitution type | Frameshift type | |||||
| TA100 | TA1535 | WP2 uvrA |
TA98 | TA1537 | ||
| S9 mix (-) | Negative | 124 135 (130) |
17 20 (19) |
26 29 (28) |
25 28 (27) |
13 15 (14) |
| S9 mix (-) | 1.2 | 137 105 (121) |
21 21 (21 |
29 29 (29) |
33 22 (28) |
18 10 (14) |
| S9 mix (-) | 4.9 | 139 123 (131) |
18 19 (19) |
32 26 (29) |
25 27 (26) |
14 16 (15) |
| S9 mix (-) | 20 | 108 95 (102) |
18 19 (19) |
26 28 (27) |
22 25 (24) |
14 16 (15) |
| S9 mix (-) | 78 | 122 91 (107) |
16 19 (18) |
28 30 (29) |
28 26 (27) |
16 14 (15) |
| S9 mix (-) | 313 | 119 105 (112) |
23 19 (21) |
33 35 (34) |
28 37 (33) |
17 18 (18) |
| S9 mix (-) | 1250 | 109 125 (117) |
23 21 (22) |
31 29 (30) |
25 27 (26) |
15 15 (15) |
| S9 mix (-) | 5000 | 102 105 (104) |
13 11 (12) |
24 31 (28) |
20 21 (21) |
7 6 (7) |
| S9 mix (+) | Negative | 141 139 (140) |
13 14 (14) |
30 30 (30) |
34 30 (32) |
17 18 (18) |
| S9 mix (+) | 1.2 | 124 120 (122) |
10 17 (14) |
26 20 (23) |
39 31 (35) |
19 11 (15) |
| S9 mix (+) | 4.9 | 97 138 (118) |
12 8 (10) |
24 30 (27) |
37 41 (39) |
12 16 (14) |
S9 mix (+) |
20 | 133 138 (136) |
10 16 (13) |
18 20 (19) |
39 29 (34) |
17 13 (15) |
S9 mix (+) |
78 | 118 126 (122) |
17 9 (13) |
29 29 (29) |
27 34 (31) |
12 15 (14) |
S9 mix (+) |
313 |
124 106 (115) |
12 16 (14) |
34 28 (31) |
27 32 (30) |
19 12 (16) |
S9 mix (+) |
1250 |
100 88 (94) |
14 12 (13) |
34 28 (31) |
27 32 (30) |
19 12 (16) |
S9 mix (+) |
5000 |
96 84 (90) |
11 9 (10) |
36 21 (29) |
17 22 (20) |
14 9 (12) |
Positive control (S9 + only) |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
Positive control (S9 + only) |
Dose (ug/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
1.0 |
Positive control (S9 + only) |
No. of colonies/plate | 612 567 (590) |
425 427 (426) |
184 184 (184) |
686 621 (654) |
1770 1832 (1801) |
Positive control (S9 - only) |
Name | B[a]P |
2AA |
2AA |
B[a]P |
B[a]P |
Positive control (S9 - only) |
Dose (ug/plate) | 5.0 | 2.0 | 10.0 | 5.0 | 5.0 |
Positive control (S9 - only) |
No. of colonies/plate | 1071 1014 (1043) |
303 332 (318) |
597 638 (618) |
255 302 (279) |
76 99 (88) |
AF-2 = 2 -(2 -Furyl)-3 -(5 -nitor-2 -furyl)acrylamide NaN3 = 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: Test results - Experiment 2
| Metabolic activation | test substance conc. (ug/plate) |
No of reverse mutations (No. of colonies/plate) |
||||
| Base pair substitution type | Frameshift type | |||||
| TA100 | TA1535 | WP2 uvrA |
TA98 | TA1537 | ||
| S9 mix (-) | Negative | 140 127 (134) |
13 19 (16) |
42 49 (36) |
17 29 (23) |
14 14 (14) |
| S9 mix (-) | 156 | 116 115 (116) |
20 18 (19) |
34 34 (34) |
18 21 (20) |
12 15 (14) |
| S9 mix (-) | 313 | 127 127 (127) |
22 20 (21) |
34 34 (34) |
18 21 (20) |
14 9 (12) |
| S9 mix (-) | 625 | 128 124 (126) |
20 13 (17) |
31 31 (31) |
20 23 (22) |
9 8 (9) |
| S9 mix (-) | 1250 | 134 120 (127) |
24 19 (22) |
31 35 (33) |
17 17 (17) |
11 10 (11) |
| S9 mix (-) | 2500 | 94 98 (96) |
8 12 (10) |
23 23 (23) |
18 9 (14) |
5 5 (5) |
| S9 mix (-) | 5000 | 99 105 (102) |
4 10 (7) |
20 26 (23) |
10 10 (10) |
2 3 (3) |
| S9 mix (+) | Negative | 151 148 (150) |
12 21 (17) |
34 38 (36) |
28 35 (32) |
18 12 (15) |
| S9 mix (+) | 156 | 160 130 (145) |
19 23 (21) |
41 34 (38) |
38 29 (34) |
14 12 (13) |
| S9 mix (+) | 313 | 152 162 (157) |
20 24 (22) |
34 37 (36) |
26 31 (29) |
11 10 (11) |
| S9 mix (+) | 625 | 162 135 (149) |
20 25 (23) |
36 32 (34) |
30 29 (30) |
11 10 (11) |
S9 mix (+) |
1250 | 150 150 (150) |
21 31 (26) |
40 39 (40) |
22 28 (25) |
18 18 (18) |
S9 mix (+) |
2500 | 147 159 (153) |
20 14 (17) |
34 36 (35) |
36 31 (34) |
17 14 (16) |
S9 mix (+) |
5000 |
102 126 (114) |
13 6 (10) |
27 30 (29) |
15 22 (19) |
9 12 (11) |
Positive control (S9 + only) |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
Positive control (S9 + only) |
Dose (ug/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
1.0 |
Positive control (S9 + only) |
No of colonies/plate |
514 461 (488) |
404 397 (401) |
172 177 (175) |
620 575 (598) |
2045 1866 (1956) |
Positive control (S9 - only) |
Name |
B [a] P |
2AA |
2AA |
B[a]P |
B[a]P |
Positive control (S9 - only) |
Dose (ug/plate) | 5.0 | 2.0 | 10.0 | 5.0 | 5.0 |
Positive control (S9 - only) |
No. of colonies/plate | 1005 1046 (1026) |
274 334 (304) |
552 682 (617) |
272 239 (256) |
92 96 (94) |
AF-2 = 2 -(2 -Furyl)-3 -(5 -nitor-2 -furyl)acrylamide NaN3 = 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:
- The substance is not considered as mutagenic under the conditions of the test.
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