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EC number: 470-080-3 | CAS number: -
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Genetic toxicity: in vitro
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:
- from 2006-02-13 to 2006-05-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2000/32/EC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Sokalan PG B62
Method
- Target gene:
- His (S. typhimurium)
Trp (E. coli)
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA1535, TA100, TA1537, TA98; Escherichia coli WP2 uvrA
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix from Aroclor 1254 induced rat livers
- Test concentrations with justification for top dose:
- Standard plate test: 56, 177, 557, 1750, 5500 µg/plate
Preincubation test: 56, 177, 557, 1750, 5500 µg/plate - Vehicle / solvent:
- Substances were dissolved in DMSO.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: With S-9 mix: 2-AA; Without S9-MIx: MNNG, NOPD, AAc, 4-NQO
- Details on test system and experimental conditions:
- Positive controls
with S-9 mix
- 2-aminoanthracene (2-AA) (SIGMA, A-1381)
2.5 µg/plate, dissolved in DMSO; strains: TA 1535, TA 100, TA 1537, TA 98
60 µg/plate, dissolved in DMSO; strain : Escherichia coli WP2 uvrA
without S-9 mi x
- N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) (FLU144, 68051)
5 µg/plate, dissolved in DMSO
strains : TA 1535, TA 100
- 4-nitro-o-phenylendiamine ( NOPD) (SIGMA, N-9504)
10 µg/plate, dissolved in DMSO
strain: TA 98
- 9-aminoacridine (AAC) (SIGMA, A-1135)
100 µg/plate, dissolved in DMSO
strain: TA 1537
- 4-nitroquinoline-N-oxide (4-NQO) (SIGMA, N-8141)
5 µg/plate, dissolved in DMSO
strain : E. coli WP2 uvrA
METHOD OF APPLICATION: in agar (plate incorporation; SPT) and preincubation (PIT)
DURATION
- Preincubation period: 20 min
- Exposure duration: 48-72 hours
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
reduction of his- background growth, decrease in the number of his+ revertants - Evaluation criteria:
- Generally, the experiment is considered valid if the following criteria are met :
The number of revertant colonies in the negative controls was within the normal range of the historical control data for each tester strain
The sterility controls revealed no indication of bacterial contamination .
The positive control articles both with and without S-9 mix induced a significant increase in the number of revertant colonies within the range of the historical control data or above.
The titer of viable bacteria was > 10E08/mL. - Statistics:
- no data on statistics
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA1535, TA100, TA1537, TA98; Escherichia coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: A slight decrease in the number of revertants was occasionally observed depending on the strain and test conditions from about 1750 µg/plate onward.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system. Precipitation of the test substance was found from about 557 µg/plate onward.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Number of revertants in the a. standard plate test and b. preincubation test after treatment with control or test substance in the various tester strains.
a.
Strain |
control |
test substance |
||
-S9 |
+S9 |
-S9 |
+S9 |
|
TA1535 |
16 ± 1 |
16 ± 2 |
16 ± 2 (177 µg) |
17 ± 1 (177 µg) |
TA100 |
114 ± 11 |
123 ± 20 |
117 ± 9 (56 µg) |
144 ± 19 (177 µg) |
TA1537 | 9 ± 2 | 10 ± 1 | 8 ± 1 (56 µg) | 9 ± 1 (177 µg) |
TA98 | 28 ± 1 | 41 ± 4 | 29 ± 2 (56 µg) | 39 ± 3 (177 µg) |
E.coli wp2 uvra | 34 ± 3 | 36 ± 4 | 29 ± 4 (177 µg) | 52 ± 9 (5500 µg) |
b.
Strain |
control |
test substance |
||
-S9 |
+S9 |
-S9 |
+S9 |
|
TA1535 |
16 ± 3 |
17 ± 3 |
19 ± 2 (1750 µg) |
15 ± 2 (557 µg) |
TA100 |
111 ± 7 |
111 ± 8 |
115 ± 6 (177 µg) |
121 ± 9 (56 µg) |
TA1537 | 10 ± 3 | 9 ± 2 | 9 ± 3 (56 µg) | 10 ± 2 (557 µg) |
TA98 | 34 ± 5 | 33 ± 2 | 32 ± 4 (56 µg) | 40 ± 4 (177 µg) |
E.coli wp2 uvra | 41 ± 4 | 36 ± 4 | 54 ± 7 (5500 µg) | 35 ± 5 (5500 µg) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate showed no mutagenic effects in a reverse mutation test (Ames test) in bacteria with and without metabolic activation. - Executive summary:
In a GLP conform Ames test according to OECD guideline 471, the substance 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate (purity: 93.0 weight-%) was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli WP2 uvrA (BASF 2006). Two independent assays were performed, a standard plate test (SPT) and a preincubation test (PIT), both with a dose range of 56 µg - 5500 µg/plate, and both with and without metabolic activation (Aroclor 1254-induced rat liver S-9 mix).
An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system. Precipitation of the test substance was found from about 557 mg/plate onward. A slight decrease in the number of revertants was occasionally observed depending on the strain and test conditions at doses >= 1750 µg/plate.
According to the results of the present study, the test substance is not mutagenic in the Salmonella typhimurium/ Escherichia coli reverse mutation assay under the experimental conditions chosen here.
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