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3,5,8,10,13,15,18,20,23,25,28,30,33,35,38,40,41,43,45,47,51,53,55,57,59,61,63, 65,67,69,71,73-dotriacontazapentacosacyclo [35.3.3.36,7.311, 12.316,17.321,22.326,27.331,32.22,41.236,43.13,40.15,8.110,13.115,18.120,23.125,28.130,33.135,38.145,51.147,73.153,55.157,59.161,63.165,67.169,71] octacontane-44,46,48,49,50,52,54,56,58,60,62,64,66,68,70,72-hexadecone, hydrochloride hydrate
EC number: 700-970-1 | CAS number: -
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OGYI/38593-5/2012
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3,5,8,10,13,15,18,20,23,25,28,30,33,35,38,40,41,43,45,47,51,53,55,57,59,61,63, 65,67,69,71,73-dotriacontazapentacosacyclo [35.3.3.36,7.311, 12.316,17.321,22.326,27.331,32.22,41.236,43.13,40.15,8.110,13.115,18.120,23.125,28.130,33.135,38.145,51.147,73.153,55.157,59.161,63.165,67.169,71] octacontane-44,46,48,49,50,52,54,56,58,60,62,64,66,68,70,72-hexadecone, hydrochloride hydrate
- EC Number:
- 700-970-1
- Molecular formula:
- C48N32H48O16xH2O
- IUPAC Name:
- 3,5,8,10,13,15,18,20,23,25,28,30,33,35,38,40,41,43,45,47,51,53,55,57,59,61,63, 65,67,69,71,73-dotriacontazapentacosacyclo [35.3.3.36,7.311, 12.316,17.321,22.326,27.331,32.22,41.236,43.13,40.15,8.110,13.115,18.120,23.125,28.130,33.135,38.145,51.147,73.153,55.157,59.161,63.165,67.169,71] octacontane-44,46,48,49,50,52,54,56,58,60,62,64,66,68,70,72-hexadecone, hydrochloride hydrate
- Test material form:
- solid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor-supplemented post-mitochondrial S9 fraction
- Test concentrations with justification for top dose:
- Based on the results of the preliminary experiment, the examined test concentrations in the main tests were 2500, 791, 250, 79.1, 25, 7.91, 2.5 and 0.791 μg/plate with and without metabolic activation. At the top dose precipitation and cytotoxicity were observed in all strains.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulfoxide, water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylenediamine; 2-aminoanthracene
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Confirmatory Mutation Test (Pre-Incubation Method)
Test Item: CUCURBIT[8]URIL
Strain: Salmonella typhimurium TA98
Cell count (overnight culture): 2.01 x 109CFU/mL
Concentration: (μg/plate) |
|
Revertant colony number |
Concentration: (μg/plate) |
|
Revertant colony number |
|||
-S9 |
+S9 |
-S9 |
|
+S9 |
||||
25000 |
|
2 SR, SP 2 SR, SP 6 SR, SP |
4 R, SP 4 R, SP 8 R, SP |
Untreated control |
|
19 21 28 |
|
29 31 35 |
Mean SD MF |
3.3 2.31 0.19 |
5.3 2.31 0.19 |
Mean SD MF |
22.7 4.73 1.28 |
|
31.7 3.06 1.10 |
||
791 |
|
12 SR 9 SR 6 SR |
10 R 10 R 10 R |
DMSO control |
|
16 17 20 |
|
27 29 30 |
Mean SD MF |
9.0 3.00 0.51 |
10.0 0.00 0.35 |
Mean SD MF |
17.7 2.08 1.00 |
|
28.7 1.53 1.00 |
||
250 |
|
11 SR 13 SR 22SR |
31 25 27 |
Positive control NPD (4 μg) |
|
293 312 302 |
2AA (2 μg) |
2366 2380 2374 |
Mean SD MF |
15.3 5.86 0.87 |
27.7 3.06 0.97 |
Mean SD MF |
302.3 9.50 17.11 |
|
2373.3 7.02 82.79 |
||
79.1 |
|
18 24 18 |
37 39 40 |
SP: Slight precipitate R: Reduced background lawn SR: Slightly reduced background lawn MF: Mutation factor SD: Standard deviation +S9: with S9 mix -S9: without S9 mix
Mean revertants (test item) Mutation factor = ------------------------------------- Mean revertants (solvent control) |
||||
Mean SD MF |
20.0 3.46 1.13 |
38.7 1.53 1.35 |
||||||
25 |
|
23 30 19 |
34 32 33 |
|||||
Mean SD MF |
24.0 5.57 1.36 |
33.0 1.00 1.15 |
||||||
7.91 |
|
30 27 22 |
34 35 25 |
|||||
Mean SD MF |
26.3 4.04 1.49 |
31.3 5.51 1.09 |
||||||
2.5 |
|
17 30 18 |
31 23 36 |
|||||
Mean SD MF |
21.7 7.23 1.23 |
30.0 6.56 1.05 |
||||||
0.791 |
|
21 19 17 |
21 19 28 |
|||||
Mean SD MF |
19.0 2.00 1.08 |
22.7 4.73 0.79 |
||||||
Confirmatory Mutation Test (Pre-Incubation Method)
Test Item: CUCURBIT[8]URIL
Strain: Salmonella typhimurium TA100
Cell count (overnight culture): 2.09 x 109CFU/mL
Concentration: (μg/plate) |
|
Revertant colony number |
Concentration: (μg/plate) |
|
Revertant colony number |
|||
-S9 |
+S9 |
-S9 |
|
+S9 |
||||
25000 |
|
22 SP, SR 37 SP, SR 19 SP, R |
26 SP, SR 28 SP, SR 13 SP, SR |
Untreated control |
|
102 96 95 |
|
81 102 109 |
Mean SD MF |
26.0 9.64 0.27 |
22.3 8.14 0.24 |
Mean SD MF |
97.7 3.79 1.00 |
|
100.7 9.07 1.09 |
||
791 |
|
63 SR 88 SR 82 SR |
97 SR 66 SR 86 SR |
DMSO control |
|
96 102 95 |
|
87 97 92 |
Mean SD MF |
77.7 13.05 0.80 |
83.0 15.72 0.90 |
Mean SD MF |
97.7 3.79 1.00 |
|
92.0 5.00 1.00 |
||
250 |
|
84 SR 81 SR 115 SR |
106 100 87 |
Distilled water control* |
|
103 97 94 |
|
92 93 109 |
Mean SD MF |
93.3 18.82 0.96 |
97.7 9.71 1.06 |
Mean SD MF |
98.0 4.58 1.00 |
|
98.0 9.54 1.07 |
||
79.1 |
|
113 85 109 |
101 67 106 |
Positive control SAZ (2 μg) |
|
1196 1212 1184 |
2AA (2 μg) |
2412 2388 2420 |
Mean SD MF |
102.3 15.14 1.05 |
91.3 21.22 0.99 |
Mean SD MF |
1197.3 14.05 12.22 |
2406.7 16.65 26.16 |
|||
25 |
|
94 87 93 |
97 107 95 |
SP:Slight precipitate R:Reduced background lawn SR:Slightly reduced background lawn MF:Mutation factor SD:Standard deviation +S9:with S9 mix -S9:without S9 mix
Mean revertants (test item) Mutation factor = -------------------------------------- Mean revertants (solvent control)
*Distilled water control was used because of SAZ |
||||
Mean SD MF |
91.3 3.79 0.94 |
99.7 6.43 1.08 |
||||||
7.91 |
|
99 98 97 |
94 109 86 |
|||||
Mean SD MF |
98.0 1.00 1.00 |
96.3 11.68 1.05 |
||||||
2.5 |
|
95 92 93 |
110 84 108 |
|||||
Mean SD MF |
93.3 1.53 0.96 |
100.7 14.47 1.09 |
||||||
0.791 |
|
108 103 85 |
66 95 104 |
|||||
Mean SD MF |
98.7 12.10 1.01 |
88.3 19.86 0.96 |
||||||
Confirmatory Mutation Test (Pre-Incubation Method)
Test Item: CUCURBIT[8]URIL
Strain: Salmonella typhimurium TA1535
Cell count (overnight culture): 2.67 x 109CFU/mL
Concentration: (μg/plate) |
|
Revertant colony number |
Concentration: (μg/plate) |
|
Revertant colony number |
|||
-S9 |
+S9 |
-S9 |
|
+S9 |
||||
25000 |
|
15 SP, SR 16 SP, SR 10 SP, SR |
5 P, SR 13 P, SR 11 P, SR |
Untreated control |
|
8 10 11 |
|
9 14 15 |
Mean SD MF |
13.7 3.21 1.46 |
9.7 4.16 0.88 |
Mean SD MF |
9.7 1.53 1.04 |
|
12.7 3.21 1.15 |
||
791 |
|
13 SR 12 SR 12 SR |
11 SR 15 SR 8 SR |
DMSO control |
|
7 10 11 |
|
10 11 12 |
Mean SD MF |
12.3 0.58 1.32 |
11.3 3.51 1.03 |
Mean SD MF |
9.3 2.08 1.00 |
|
11.0 1.00 1.00 |
||
250 |
|
14 SR 15 SR 14 SR |
10 15 8 |
Distilled water control* |
|
13 14 16 |
|
11 15 15 |
Mean SD MF |
14.3 0.58 1.54 |
11.0 3.61 1.00 |
Mean SD MF |
14.3 1.53 1.54 |
|
13.7 2.31 1.24 |
||
79.1 |
|
14 19 8 |
10 12 17 |
Positive control SAZ (2 μg) |
|
1204 1176 1184 |
2AA (2 μg) |
267 277 283 |
Mean SD MF |
13.7 5.51 1.46 |
13.0 3.61 1.18 |
Mean SD MF |
1188.0 14.42 82.88 |
275.7 8.08 25.06 |
|||
25 |
|
13 13 18 |
13 10 10 |
P:Precipitate SP:Slight precipitate SR:Slightly reduced background lawn MF:Mutation factor SD:Standard deviation +S9:with S9 mix -S9:without S9 mix
Mean revertants (test item) Mutation factor = -------------------------------------- Mean revertants (solvent control)
*Distilled water control was used because of SAZ |
||||
Mean SD MF |
14.7 2.89 1.57 |
11.0 1.73 1.00 |
||||||
7.91 |
|
13 13 11 |
15 12 15 |
|||||
Mean SD MF |
12.3 1.15 1.32 |
14.0 1.73 1.27 |
||||||
2.5 |
|
11 10 14 |
16 19 10 |
|||||
Mean SD MF |
11.7 2.08 1.25 |
15.0 4.58 1.36 |
||||||
0.791 |
|
14 16 15 |
14 19 15 |
|||||
Mean SD MF |
15.0 1.00 1.61 |
13.0 2.65 1.18 |
||||||
Confirmatory Mutation Test (Pre-Incubation Method)
Test Item: CUCURBIT[8]URIL
Strain: Salmonella typhimurium TA1537
Cell count (overnight culture): 2.26 x 109CFU/mL
Concentration: (μg/plate) |
|
Revertant colony number |
Concentration: (μg/plate) |
|
Revertant colony number |
|||
-S9 |
+S9 |
-S9 |
|
+S9 |
||||
25000 |
|
1 P,R 1 P,R 2 P,R |
0 P,R 1 P,R 2 P,R |
Untreated control |
|
7 8 11 |
|
3 6 7 |
Mean SD MF |
1.3 0.58 0.19 |
1.0 1.00 0.14 |
Mean SD MF |
8.7 2.08 1.24 |
|
5.3 2.08 0.76 |
||
791 |
|
3 SP,SR 5 SP,SR 6 SP,SR |
5 SR 8 SR 11 SR |
DMSO control |
|
5 7 9 |
|
6 7 8 |
Mean SD MF |
4.7 1.53 0.67 |
8.0 3.00 1.14 |
Mean SD MF |
7.0 2.00 1.00 |
|
7.0 1.00 1.00 |
||
250 |
|
5 SR 5 SR 8 SR |
5 10 17 |
Positive control 9AA (50 μg) |
|
404 426 408 |
2AA (2 μg) |
198 204 220 |
Mean SD MF |
6.0 1.73 0.86 |
10.7 6.03 1.52 |
Mean SD MF |
412.7 11.72 58.95 |
|
207.3 11.37 29.62 |
||
79.1 |
|
6 7 9 |
4 11 12 |
P:Precipitate SP:Slight precipitate R:Reduced background lawn SR:Slightly reduced background lawn MF:Mutation factor SD:Standard deviation +S9:with S9 mix -S9:without S9 mix
Mean revertants (test item) Mutation factor = ------------------------------------ Mean revertants (solvent control) |
||||
Mean SD MF |
7.3 1.53 1.05 |
9.0 4.36 1.29 |
||||||
25 |
|
7 11 14 |
9 11 14 |
|||||
Mean SD MF |
10.7 3.51 1.52 |
11.3 2.52 1.62 |
||||||
7.91 |
|
6 7 11 |
7 10 12 |
|||||
Mean SD MF |
8.0 2.65 1.14 |
9.7 2.52 1.38 |
||||||
2.5 |
|
4 6 17 |
10 12 13 |
|||||
Mean SD MF |
9.0 7.00 1.29 |
11.7 1.53 1.67 |
||||||
0.791 |
|
5 8 11 |
10 10 11 |
|||||
Mean SD MF |
8.0 3.00 1.14 |
10.3 0.58 1.48 |
||||||
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with and without metabolic activation
The reported data of this mutagenicity assay show that under the experimental conditions applied the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. In conclusion, the test item CUCURBIT[8]URIL had no mutagenic activity in the examined bacterial strains under the test conditions of this study. - Executive summary:
The purpose of this study was to evaluate the mutagenic potential of the test item by measuring its ability to induce reverse mutations at selected loci of several strains of Salmonella typhimuriumand at the tryptophan locus of Escherichia coli WP2uvrA strain in the presence and absence of activated rat liver S9 fraction. Study was performed to – Ninth Addendum to OECD Guidelines for Testing of Chemicals, Section 4, No. 471, "Bacterial Reverse Mutation Test", 21 July 1997 – EPA Health Effects Test Guidelines, OPPTS 870.5100 "Bacterial Reverse Mutation Test", EPA
712-C-98-247, August 1998 – Commission Regulation (EC) No. 440/2008, B.13/14. "Mutagenicity: Reverse Mutation Test Using Bacteria", 30 May 2008 The method described in the above mentioned guidelines conforms to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF.
In conclusion The reported data of this mutagenicity assay show that under the experimental conditions applied the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
In conclusion, the test item CUCURBIT[8]URIL had no mutagenic activity in the examined bacterial strains under the test conditions of this study.
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