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EC number: 275-809-7 | CAS number: 71662-46-9
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
- Study period:
- 1990-09-03 to 1990-09-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters
- EC Number:
- 275-809-7
- EC Name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters
- Cas Number:
- 71662-46-9
- Molecular formula:
- C24H38O4 - C28H46O4
- IUPAC Name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Phthalic acid, di-n-octyl, n-decyl ester
- Substance type: product
- Physical state: liquid
- Stability under test conditions: not determined
- Storage condition of test material: room temperature in the dark
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced liver S9 mix
- Test concentrations with justification for top dose:
- Dose range finding test: 5000, 500, 50, 5 µg/plate
Mutation tests: 5000, 1500, 500, 150, 50 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: not mentioned
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- buffer
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 9-Aminoacredine, at 80 µg/plate with TA 1537; N-Ethyl-N'-nitro-N-nitrosoguanidine at 3 µg/plate with TA 100 and at 5 µg/plate with TA 1535; 2-Nitrofluorene at 1 µg/plate with TA 98 and at 2 µg/plate with TA 1538
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- S9 mix
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene at 0.5 µg/plate with TA 1538 and TA 98; at 1 µg/plate with TA 100; at 2 µg/plate with TA 1535 and TA 1537
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation, two independent tests were performed: Bacterial culture, test substance dissolved in Ethanol, sterile sodium othophosphate buffer (pH 7.4) or S9-mix were given into sterile bijou bottles, histidine deficient agar was added, thoroughly mixed and then overlaid onto minimal agar plates.
DURATION
- Preincubation period: not applicable
- Exposure duration: at least 3 days
NUMBER OF REPLICATIONS: 3 per concentration
DETERMINATION OF CYTOTOXICITY
- Method: Any toxic effects were detected by a substantial reduction in revertant colony counts or by the absence of a complete background bacterial lawn
OTHER EXAMINATIONS:
- Other: A preliminary toxicity test was conducted for range finding purposes - Evaluation criteria:
- The test compound is considered to show evidence of mutagenic activity if it induces an at least 2-fold increase in revertant colony numbers compared to solvent control with some evidence of a positive dose-relationship in two seperate experiments with any bacterial strain either in the presence or in the absence of metabolic activation. The test substance is considered to show no evidence of mutagenic activity if it does not produce reproducible increases of at least 1.5 times the concurrent solvent controls, at any dose level with any bacterial strain. If the results fail to satisfy the criteria for a clear "positive" or "negative" response the following approach is taken: Repeat test may be performed using modifications (e. g. in dose range). If no clear "positive" response can be obtained the test data may be subjected to statistical analysis to determine the statistical significance of any observed increases.
- Statistics:
- analysis of variance followed by Student's T test
Results and discussion
Test resultsopen allclose all
- Key result
- 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
- Key result
- 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
- Key result
- 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
- Key result
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1538
- 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: No cytotoxicity up to the highest concentation of 5000 µg/plate was seen in the tester strains.
COMPARISON WITH HISTORICAL CONTROL DATA: not performed
ADDITIONAL INFORMATION ON CYTOTOXICITY: none - Remarks on result:
- other: strain/cell type: Salmonella typhimurium
Any other information on results incl. tables
Table #1: Plate incorporation test #1: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 1535] |
[Strain TA 1537] |
[Strain TA 1538] |
||||||
Conc. |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
0* |
10±1.5 |
11±3.5 |
no |
9±1.2 |
9±1.5 |
no |
10±0.6 |
14±1.2 |
no |
50 |
12±1.5 |
11±3.2 |
no |
9±2.1 |
9±2.1 |
no |
8± 1.2 |
12±0.6 |
no |
150 |
9±3.0 |
11±3.2 |
no |
9±1.0 |
9±1.5 |
no |
8±1.7 |
9±3.0 |
no |
500 |
9±2.6 |
9±1.0 |
no |
11±2.3 |
12±1.2 |
no |
9±3.1 |
11±0.6 |
no |
1500 |
9±1.2 |
10±2.5 |
no |
10±2.5 |
12±0.6 |
no |
8±1.5 |
12±2.3 |
no |
5000 |
7±0.6 |
11±1.0 |
no |
10±2.1 |
10±0.6 |
no |
11±2.1 |
14±2.5 |
no |
Positive control |
986±85.7 |
70±4.2 |
no |
X |
47±3.2 |
no |
59±8.5 |
56±1.5 |
no |
*solvent control with Ethanol X = too many colonies to count accurately
Table #2: Plate incorporation test #1: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 98] |
[Strain TA 100] |
[-] |
||||||
Conc. |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
|||
0* |
20±3.5 |
23±1.5 |
no |
98±3.5 |
110±6.0 |
no |
|
|
|
50 |
18±2.6 |
23±5.0 |
no |
82±5.5 |
101±2.6 |
no |
|
|
|
150 |
18±2.1 |
19±1.5 |
no |
84±6.5 |
104±5.2 |
no |
|
|
|
500 |
20±3.2 |
21±5.0 |
no |
96±9.3 |
99±1.2 |
no |
|
|
|
1500 |
19±0.6 |
21±4.6 |
no |
83±6.2 |
90±16.6 |
no |
|
|
|
5000 |
20±3.5 |
23±5.3 |
no |
69±2.1 |
104±1.7 |
no |
|
|
|
Positive control |
64±4.0 |
67±11.2 |
no |
484±17.5 |
324±20.6 |
no |
|
|
|
*solvent control with Ethanol
Table #3: Plate incorporation test #2: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 1535] |
[Strain TA 1537] |
[Strain TA 1538] |
||||||
Conc. |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
0* |
5±1.5 |
11±4.6 |
no |
10±4.0 |
14±1.7 |
no |
16±3.5 |
16±0.0 |
no |
50 |
5±1.5 |
12±2.1 |
no |
42.1 |
6±1.2 |
no |
7±1.5 |
13±2.1 |
no |
150 |
10±2.5 |
12±1.5 |
no |
4±2.5 |
6±1.5 |
no |
14±2.6 |
12±2.0 |
no |
500 |
8±1.7 |
11±1.5 |
no |
9±3.0 |
9±1.5 |
no |
6±1.5 |
11±2.1 |
no |
1500 |
5±1.5 |
12±2.3 |
no |
4±1.7 |
5±0.6 |
no |
8±1.5 |
12±3.0 |
no |
5000 |
8±4.2 |
9±1.0 |
no |
8±2.5 |
6±2.0 |
no |
7±2.0 |
16±1.7 |
no |
Positive control |
329± 108.6 |
111±9.5 |
no |
2261± 38.3 |
57±2.5 |
no |
44±4.6 |
42±3.0 |
no |
*solvent control with Ethanol
Table #4: Plate incorporation test #2: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 98] |
[Strain TA 100] |
[-] |
||||||
Conc. |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
|||
0* |
21±3.8 |
22±4.0 |
no |
91±8.0 |
99±5.8 |
no |
|
|
|
50 |
19±2.1 |
22±2.0 |
no |
84±7.6 |
87±9.5 |
no |
|
|
|
150 |
22±2.3 |
21±4.0 |
no |
86±7.2 |
84±5.3 |
no |
|
|
|
500 |
22±2.8 |
24±3.2 |
no |
90±7.0 |
98±4.0 |
no |
|
|
|
1500 |
19±2.1 |
24±1.5 |
no |
86±2.3 |
90±14.8 |
no |
|
|
|
5000 |
20±3.1 |
19±4.0 |
no |
91±1.0 |
89±14.7 |
no |
|
|
|
Positive control |
60±2.1 |
87±15.9 |
no |
353±12.4 |
336±11.5 |
no |
|
|
|
*solvent control with Ethanol
Applicant's summary and conclusion
- Conclusions:
- It was concluded that the target substance 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters showed no evidence of mutagenic activity when tested in this bacterial system.
- Executive summary:
It was concluded that 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters showed no evidence of mutagenic activity when tested in this bacterial system.
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