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EC number: - | 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
- Study period:
- 2014-01-21 to 2014-08-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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:
- other: International Conference on Harmonisation (ICH) Guidelines S2A and S2B
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- benzyl butyl cis-cyclohexane-1,2-dicarboxylate
- Cas Number:
- 1931129-39-3
- Molecular formula:
- C19H26O4
- IUPAC Name:
- benzyl butyl cis-cyclohexane-1,2-dicarboxylate
- Test material form:
- other: Clear yellow liquid
- Details on test material:
- - Test substance name: Santicizer Platinum P-1400
- LotNo.: 644878
- Supplied by: Ferro Corporation (Bridgeport, NJ)
- Received: ambient conditions
- Storing conditions: room temperature (22 ± 3 °C).
Constituent 1
- Specific details on test material used for the study:
- Test Material: Santicizer Platinum P-1400
Lot no: 644878
Supplier: Ferro Corporation (Bridgeport, NJ)
Manufactured date: 25 Semptember 2013
The sample was received at ambient conditions and stored at room temperature
(22 ± 3 °C).
Method
- Target gene:
- TA1537, TA98, TA100, TA1535, WP2 uvrA
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Rat liver S9 homogenate
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor™ 1254-induced rat liver S9 fraction
- Test concentrations with justification for top dose:
- In the confirmatory assay, Santicizer Platinum P-1400 was tested at 25, 50, 100, 250, 500, 1000, 2500 and 5000 µg/plate using the plate incorporation method.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethylsulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- other: ICR-191 acridine, 2-aminoanthracene
- Details on test system and experimental conditions:
- For detection of potential- acting mutagens, the Aroclor 1254-induced rat liver S9 fraction was used. The metabolic activation mixture was prepared freshly everyday. The S9 mixture (7.5%v/v) consisted of:
0.75 mL of S9 fraction
0.20 mL of MgCl2 (0.4 M) - KCl (1.65 M)
0.05 mL of glucose-6-phosphate (1 M)
0.40 mL of nicotinamide adenine dinucleotide phosphate (NADP) (0.1 M)
5.00 mL of phosphate buffered saline
3.60 mL of sterile distilled deionized water - Evaluation criteria:
- Criteria for Acceptability and Interpretation of Assay
The vehicle and positive control substance plates for the current study were compared against revertant count ranges that are found in historical data ranges.
Criteria for Positive Response
The test substance was considered positive for mutagenicity if it induced an increase of revertants per plate with increasing concentration. The increases should be at least twotimes the vehicle control substance background frequency for strains with highspontaneous levels (i.e., TA100) and three times for those with low spontaneous levels(TA1537, TA98, TA1535 and WP2 uvrA). These increases should be seen in at least twoor more successive concentrations or the response should be repeatable at a single concentration.
Criteria for Negative Response
The test substance was considered to be negative for inducing mutagenicity if it did not induce a response which fulfills the criteria for a positive response.
Criteria for Equivocal Response
Cases which did not clearly fit into the positive or negative criteria may be judged equivocal. In these cases the Study Director, based on sound scientific judgment, may take additional factors into consideration in evaluating the test results. - Statistics:
- For each concentration level and for each condition, the mean revertant count and standard deviation (SD) were determined.
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 5000 µg/plate in TA1535 without metabolic activation
- Vehicle controls validity:
- valid
- 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:
- ≥250 µg/plate in TA1537 without metabolic activation
- Vehicle controls validity:
- valid
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- 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 µg/plate in TA100 with and without metabolic activation
- Vehicle controls validity:
- valid
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitates were observed at >=500 ug/plate in all strains without metabolic activation and at >=2500 ug/plate in TA100 with and without metabolic activation.
- Remarks on result:
- other: strain/cell type: Aroclor 1254-induced rat liver S9 fraction
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Initial Assay: Summary Results of Plate Incorporation Experiment: Revertant Colonies per Plate - Mean (SD)a |
||||||
Treatment Group |
µg/plate |
TA1537 |
TA98 |
TA100 |
TA1535 |
WP2uvrA |
Without Metabolic Activation (-S9) |
||||||
Dimethylsulfoxide (DMSO) |
100 µL |
4 (2) |
13 (3) |
88 (13) |
10 (3) |
16 (5) |
ICR-191 Acridine (ICR) |
0.5 |
272 (31) |
|
|
|
|
2-Nitrofluorene (2-NF) |
2.5 |
|
516 (72) |
|
|
|
Sodium azide (SA) |
1.0 |
|
|
496 (24) |
355 (15) |
|
4-nitroquinoline-N-oxide (NQNO) |
2.0 |
|
|
|
|
2533 (77) |
|
||||||
Santicizer Platinum P-1400 |
25 |
5 (2) |
10 (3) |
78 (8) |
9 (7) |
14 (4) |
50 |
5 (1) |
15 (2) |
84 (14) |
7 (1) |
14 (5) |
|
100 |
3 (1) |
14 (2) |
75 (21) |
7 (3) |
17 (1) |
|
250 |
3 (1) |
13 (2) |
62b(4) |
3 (1) |
17 (1) |
|
500d |
5 (1) |
15 (8) |
58b (14) |
6 (5) |
13 (5) |
|
1000d |
2 (0) |
15 (3) |
--c-- |
6 (3) |
17 (1) |
|
2500d |
3 (3) |
14 (7) |
--c-- |
5 (3) |
12 (3) |
|
5000d |
6 (2) |
13 (10) |
--c-- |
8 (1) |
17 (6) |
|
With Metabolic Activation (+S9) |
||||||
Dimethylsulfoxide (DMSO) |
100 µL |
7 (3) |
16 (5) |
94 (18) |
11 (3) |
16 (2) |
2-Aminoanthracene (2AA) |
2.5 |
61 (11) |
1253 (100) |
496 (116) |
102 (14) |
|
2-Aminoanthracene (2AA) |
10.0 |
|
|
|
|
176 (129) |
|
||||||
Santicizer Platinum P-1400 |
25 |
10 (5) |
22 (2) |
86 (15) |
10 (6) |
19 (4) |
50 |
3 (2) |
18 (7) |
102 (25) |
6 (0) |
21 (5) |
|
100 |
6 (3) |
17 (6) |
86 (11) |
10 (2) |
24 (9) |
|
250 |
5 (3) |
21 (5) |
66b(3) |
9 (3) |
19 (3) |
|
500d |
3 (1) |
18 (3) |
75b(9) |
7 (4) |
17 (4) |
|
1000d |
3 (3) |
23 (12) |
--c-- |
6 (3) |
14 (4) |
|
2500d |
6 (3) |
20 (3) |
--c-- |
8 (3) |
18 (3) |
|
5000d |
4 (2) |
18 (6) |
--c-- |
6 (4) |
25 (7) |
|
a Calculated from triplicate plates
b Slightly reduced background lawn
c Cytotoxicity: Reduced background lawn, plates not counted
d Precipitates present
Table 2. Confirmatory Assay: Summary Results of Plate Incorporation Experiment: Revertant Colonies per Plate - Mean (SD)a |
||||||
Treatment Group |
µg/plate |
TA1537 |
TA98 |
TA100 |
TA1535 |
WP2uvrA |
Without Metabolic Activation (-S9) |
||||||
Dimethylsulfoxide (DMSO) |
100 µL |
5 (2) |
28 (5) |
98 (17) |
9 (5) |
25 (7) |
ICR-191 Acridine (ICR) |
0.5 |
284 (44) |
|
|
|
|
2-Nitrofluorene (2-NF) |
2.5 |
|
712 (74) |
|
|
|
Sodium azide (SA) |
1.0 |
|
|
610 (41) |
365 (18) |
|
4-nitroquinoline-N-oxide (NQNO) |
2.0 |
|
|
|
|
2202 (228) |
|
||||||
Santicizer Platinum P-1400 |
25 |
3 (2) |
26 (4) |
79 (6) |
8 (3) |
27 94) |
50 |
9 (2) |
24 (8) |
70 (11) |
5 (2) |
30 (7) |
|
100 |
6(3) |
20 (1) |
72 (3) |
10 (1) |
30 (8) |
|
250 |
--c-- |
21 (3) |
64 (2) |
10 (5) |
34 (11) |
|
500e |
--c-- |
25 (6) |
69b(1) |
9 (2) |
29 (6) |
|
1000e |
--c-- |
24 (10) |
69b(7) |
9 (3) |
30 (6) |
|
2500e |
--c-- |
17 (6) |
--c-- |
8 (5) |
35 (7) |
|
5000e |
--c-- |
28 (16) |
--c-- |
4d(1) |
35 (10) |
|
With Metabolic Activation (+S9) |
||||||
Dimethylsulfoxide (DMSO) |
100 µL |
6 (1) |
25 (3) |
92 (11) |
12 (3) |
27 (10) |
2-Aminoanthracene (2AA) |
2.5 |
55 (14) |
1243 (52) |
695 (129) |
72 (9) |
|
2-Aminoanthracene (2AA) |
10.0 |
|
|
|
|
160 (21) |
|
||||||
Santicizer Platinum P-1400 |
25 |
5 (3) |
34 (4) |
82 (10) |
7 (1) |
25 (2) |
50 |
8 (2) |
18 (1) |
84 (8) |
10 (5) |
21 (10) |
|
100 |
6 (1) |
29 (5) |
84 (12) |
9 (3) |
30 (0) |
|
250 |
5 (2) |
18 (9) |
91 (15) |
4 (2) |
26 (8) |
|
500 |
7 (2) |
28 (4) |
74b(6) |
7 94) |
32 (7) |
|
1000 |
4 (4) |
21 (0) |
85b(10) |
7 (1) |
25 (2) |
|
2500e |
5 (2) |
34 (13) |
--c-- |
9 (2) |
32 (5) |
|
5000e |
8 (6) |
32 (4) |
--c-- |
6 (1) |
31 (3) |
|
a Calculated from triplicate plates
b Slightly reduced background lawn
c Cytotoxicity: Reduced background lawn, plates not counted
d Cytotoxicity: >50% reduction in mean number of revertant colonies
e Precipitates present
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
The test material Santicizer Platinum P1400 is considered to be negative for inducing mutagenicity under the condition of this study. - Executive summary:
The test material Santicizer Platinum P1400 was evaluated for mutagenic activity in the vistro Salmonella-E coli/mammalian microsome reverse assay using the plate incorporation method. In the initial assay, Santicizer Platinum P-1400 was tested at 25, 50, 100, 250, 500, 1000, 2500 and 5000 µg/plate using the plate incorporation method. Precipitates were observed at ≥500 µg/plate in all strains without metabolic activation and at ≥2500 µg/plate in all strains with metabolic activation. Cytotoxicity was observed at ≥1000 µg/plate in TA100 with and without metabolic activation.
In the confirmatory assay, Santicizer Platinum P-1400 was tested at 25, 50, 100, 250,500, 1000, 2500 and 5000 µg/plate using the plate incorporation method. Precipitates were observed at ≥500 µg/plate in all strains without metabolic activation and at ≥2500 µg/plate in all strains with metabolic activation. Cytotoxicity was observed at ≥250 µg/plate in TA1537 without metabolic activation, at ≥2500 µg/plate in TA100 with and without metabolic activation, and at 5000 µg/plate in TA1535 without metabolic activation.
In both assays, criteria for a negative response were met for all tester strains with and without metabolic activation. In conclusion, the test material Santicizer Platinum P1400 is considered to be negative for inducing mutagenicity under the condition of this study.
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