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EC number: 939-682-8 | CAS number: -
Genetic toxicity: in vitro
Some information in this page has been claimed confidential.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
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:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
- Target gene:
- His-operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA1535, TA102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and β-Naphtoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 1. Study: 0.016, 0.05, 0.16, 0.50, 1.60 mg/plate (TA97a, TA100 ± S9; TA1535 - S9); 0.05, 0.16, 0.50, 1.60, 5.00 mg/plate (TA98, TA102 ± S9; TA1535 + S9);
2. Study: 0.005, 0.016, 0.05, 0.16, 0.50 mg/plate (TA97a, TA102 ± S9; TA100, TA1535 - S9); 0.016, 0.05, 0.16, 0.50, 1.60 mg/plate (TA98, TA102 ± S9; TA100, TA1535 + S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR 191, 0.5 µg/plate
- Remarks:
- TA97a without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenylene-diamine, 0.5 µg/plate
- Remarks:
- TA98 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Nitrofurantoine, 0.2 µg/plate
- Remarks:
- TA100 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 without S9 Migrated to IUCLID6: 0.25 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene, 2 µg/plate
- Remarks:
- TA97a, TA98, TA100, TA1535 with S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cumene hydroperoxide
- Remarks:
- TA102 without S9 Migrated to IUCLID6: 100 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Danthron, 30 µg/plate
- Remarks:
- TA102 with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays): histidine prototrophy
NUMBER OF REPLICATIONS: triplicates
DETERMINATION OF CYTOTOXICITY
- Method: other: reduction of background lawn - Evaluation criteria:
- The test item was interpreted as mutagenic if a concentration effect relationship occurred and the induction rate was equal to or greater than 2.
Spontaneous revertants/plate had to be within historical ranges, and the induction rates of the positive controls had to be equal to or greater than 2 to consider the test valid. - Statistics:
- Arithmetic mean values and standard deviations were calculated from colonies per plate of three replicates. For evaluation of the results the induction rate of the mean values was calculated by division of the number of revertant colonies of the test item by the number of revertant colonies of the corresponding control.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Lowest cytotoxic concentration without and with S9 (mg/plate): TA97a (0.5 and 1.6, resp.)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Lowest cytotoxic concentration without and with S9 (mg/plate): TA98 (1.6 and 5.0, resp.)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Lowest cytotoxic concentration without and with S9 (mg/plate): TA 100 (1.6 without S9 only)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Lowest cytotoxic concentration without and with S9 (mg/plate): 5.0 and 5.0, resp
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Lowest cytotoxic concentration without and with S9 (mg/plate): 1.6 and 5.0, resp.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Test concentrations were selected based on the results of a preliminary test (non-GLP)
COMPARISON WITH HISTORICAL CONTROL DATA:
The spontaneous revertants/plate (negative controls) had to be within the following ranges:
TA97a ± S9: 150 - 450;
TA98 ± S9: 15 - 50;
TA100 ± S9: 60 - 200;
TA102 ± S9: 300 - 600;
TA1535 ± S9: 5 - 30
Any other information on results incl. tables
Study 1:
Maximum number of revertants (mean ± SD):
Strain |
-S9 |
+S9 |
||||
Control |
Test group (mg/plate) |
Induction rate |
Control |
Test group (mg/plate) |
Induction rate |
|
TA97a |
251 ± 10.5 |
288 ± 1.1 (0.16) |
1.1 |
282 ± 15.3 |
252 ± 14.5 (0.16) |
0.9 |
TA98 |
35 ± 7.1 |
33 ± 7.5 (0.05) |
1.0 |
38 ± 6.1 |
39 ± 12.0 (0.16) |
1.0 |
TA100 |
93 ± 8.2 |
104 ± 12.2 (0.016) |
1.1 |
73 ± 8.2 |
82 ± 9.5 (0.5) |
1.1 |
TA102 |
429 ± 8.3 |
444 ± 36.7 (0.5) |
1.0 |
519 ± 16.3 |
519 ± 11.5 (0.16) |
1.0 |
TA1535 |
18 ± 4.0 |
28 ± 3.1 (0.05) |
1.5 |
7 ± 2.5 |
14 ± 3.6 (0.05) |
1.9 |
Study 2:
Maximum number of revertants (mean ± SD):
Strain |
-S9 |
+S9 |
||||
Control |
Test group (mg/plate) |
Induction rate |
Control |
Test group (mg/plate) |
Induction rate |
|
TA97a |
281 ± 26.1 |
239 ± 12.2 (0.05) |
0.8 |
298 ± 41.6 |
273 ± 21.1 (0.05) |
0.9 |
TA98 |
22 ± 10.4 |
41 ± 5.5 (1.6) |
1.4 |
33 ± 2.6 |
35 ± 1.5 (0.5) |
1.1 |
TA100 |
127 ± 14.2 |
111 ± 13.1 (0.016) |
0.9 |
91 ± 8.0 |
91 ± 7.1 (0.5) |
1.0 |
TA102 |
349 ± 20.4 |
355 ± 41.7 (0.05) |
1.0 |
451 ± 34.3 |
462 ± 19.1 (0.5) |
1.0 |
TA1535 |
29 ± 2.5 |
32 ± 1.7 (0.005) |
1.1 |
11 ± 2.1 |
10 ± 3.1 (0.016) |
0.9 |
Conclusion:
The test substance was not mutagenic to bacteria under the conditions chosen.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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