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EC number: 294-585-1 | CAS number: 91744-23-9
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to internationally accepted testing guideline, well documented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 91744-23-9
- Molecular formula:
- UVCB, not applicable
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- - Substance type: product
- Physical state: viscous yellow paste
- Purity: 99.8%
- Stability under test conditions: > 1 year
- Storage condition of test material: at room temperatures in the dark
- Manufacture date: May 1995
- Lot/batch No.: 505024
- Expiration date of the lot/batch: not earlier than May 1996
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: TA 98 his mutation: D3052; other markers: rfa uvrB; plasmid: pKM101 / TA 100 his mutation: G46; other markers: rfa uvrB; plasmid: pKM101 / TA 1535 his mutation: G46; other markers: rfa uvrB; / TA 1537 his mutation: C3076; other markers: rfa uvrB.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced liver S9 mix
- Test concentrations with justification for top dose:
- 50 / 160 / 500 / 1600 / 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: tetrahydrofurane
- Justification for choice of solvent/vehicle: not mentioned
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO and tetrahydrofurane
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Nitrofluorene (2.5 µg/plate) for the strains TA 98; Sodium azide (5.0 µg/plate) for TA 100; Sodium azide (2.5 µg/plate) for TA 1535; 9-Aminoacridine (5.0 µg/plate) for TA 1537.
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2.5 µg/plate) with all strains
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation, performed in two independent tests
DURATION
- Preincubation period: 30 minutes
- Exposure duration: 96 hours
NUMBER OF REPLICATIONS: 3 per concentration
DETERMINATION OF CYTOTOXICITY
- Method: not mentioned
OTHER EXAMINATIONS:
- Other: Determination of the frequency of induced or spontaneous reversion to histidine independence with negative controls (H2O), solvent controls (DMSO), test substance concentrations and positive controls; determination of the titers of overnight cultures
OTHER: none - Evaluation criteria:
- According to Ames a test article which caused no mutagenic effects at a concentration of 5000 µg/plate will be called non-mutagenic.
- Statistics:
- no statistics performed
Results and discussion
Test resultsopen allclose all
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- 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 1537
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not measured
- Effects of osmolality: not applicable
- Evaporation from medium: not applicable
- Water solubility: not mentioned
- Precipitation: no
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: not performed
COMPARISON WITH HISTORICAL CONTROL DATA: not performed
ADDITIONAL INFORMATION ON CYTOTOXICITY: none - Remarks on result:
- other: strain/cell type: Salmonella typhimurium
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table #1: Plate incorporation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 98] |
[Strain TA 100] |
[Strain TA 1535] |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
16 ± 3 |
48 ± 10 |
no |
146 ± 16 |
168 ± 10 |
no |
8 ± 3 |
12 ± 3 |
no |
50 |
14 ± 2 |
39 ± 8 |
no |
166 ± 1 |
163 ± 8 |
no |
6 ± 1 |
9 ± 2 |
no |
160 |
18 ± 1 |
50 ± 5 |
no |
136 ± 16 |
168 ± 3 |
no |
7 ± 1 |
15 ± 4 |
no |
500 |
15 ± 7 |
49 ± 8 |
no |
182 ± 13 |
172 ± 9 |
no |
10 ± 3 |
12 ± 4 |
no |
1600 |
18 ± 7 |
59 ± 9 |
no |
175 ± 11 |
163 ± 15 |
no |
7 ± 1 |
12 ± 5 |
no |
5000 |
21 ± 4 |
55 ± 4 |
no |
166 ± 18 |
179 ± 8 |
no |
7 ± 2 |
18 ± 4 |
no |
Positive control |
8.4 |
7.3 |
no |
499 ± 38 |
2028 ± 39 |
no |
242 ± 34 |
215 ± 14 |
no |
*solvent control with THF
Table #2: Plate incorporation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 1537] |
||
Conc. |
- MA |
+ MA |
Cytotoxic |
0* |
7 ± 1 |
13 ± 3 |
no |
50 |
10 ± 3 |
16 ± 5 |
no |
160 |
11 ± 2 |
15 ± 4 |
no |
500 |
11 ± 1 |
21 ± 2 |
no |
1600 |
15 ± 3 |
21 ± 2 |
no |
5000 |
13 ± 1 B,P |
20 ± 4 |
no |
Positive control |
49 ± 14 |
154 ± 13 |
no |
*solvent control with THF; B = background lawn reduced; Precipitation
Table #3: Preincubation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 98] |
[Strain TA 100] |
[Strain TA 1535] |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
21 ± 5 |
22 ± 6 |
no |
81 ± 8 |
84 ± 9 |
no |
9 ± 2 |
6 ± 3 |
no |
50 |
24 ± 4 |
23 ± 6 |
no |
101 ± 16 |
77 ± 11 |
no |
7 ± 3 |
9 ± 2 |
no |
160 |
19 ± 4 |
17 ± 6 |
no |
88 ± 10 |
81 ± 11 |
no |
6 ± 3 |
8 ± 2 |
no |
500 |
24 ± 4 |
20 ± 3 |
no |
66 ± 2 |
82 ± 8 |
no |
4 ± 2 |
9 ± 2 |
no |
1600 |
24 ±3 |
17 ± 4 |
no |
82 ± 4 |
93 ± 15 |
no |
7 ± 3 |
9 ± 3 |
no |
5000 |
23 ± 9 |
19 ± 3 |
no |
80 ± 10 |
104 ± 20 |
no |
10 ± 6 |
11 ± 1 |
no |
Positive control |
103 ± 17 |
1059 ± 330 |
no |
539 ± 17 |
1033 ± 163 |
no |
327 ± 46 |
220 ± 49 |
no |
*solvent control with THF
Table #4: Preincubation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 1537] |
||
Conc. |
- MA |
+ MA |
Cytoxic (yes/no) |
0* |
8 ±3 |
11 ± 4 |
no |
50 |
7 ± 2 |
9 ± 3 |
no |
160 |
6 ± 2 |
11 ± 3 |
no |
500 |
10 ± 3 |
13 ± 1 |
no |
1600 |
7 ± 1 |
14 ± 2 |
no |
5000 |
6 ± 4 |
11 ± 3 |
no |
Positive control |
55 ± 22 |
143 ± 35 |
no |
*solvent control with THF
Applicant's summary and conclusion
- Conclusions:
- The test substance is negative in the Bacterial Reverse Mutation Assay with and without metabolic activation.
- Executive summary:
In a Bacterial Reverse Mutation Assay according to OECD 471, strains TA 1535, TA 1537, TA 98 and TA 100 of S. typhimurium were exposed to the test substance (CAS 91744-23-9) in solvent tetrahydrofurane at concentrations of 50 / 160 / 500 / 1600 / 5000 µg/plate (plate incorporation) in the presence and absence of mammalian metabolic activation (aroclor 1254 induced liver S9 mix).
There was no evidence of induced mutant colonies over background.
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