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EC number: 201-877-4 | CAS number: 89-04-3
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:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted according to internationally recognised test methods.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Also compliant with Guideline for Screening Mutagenicity Testing of Chemicals Japan
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trioctyl benzene-1,2,4-tricarboxylate
- EC Number:
- 201-877-4
- EC Name:
- Trioctyl benzene-1,2,4-tricarboxylate
- Cas Number:
- 89-04-3
- Molecular formula:
- C33H54O6
- IUPAC Name:
- 1,2,4-trioctyl benzene-1,2,4-tricarboxylate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Lot/batch No.: C-120
Method
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction (mixed induction rat liver preparation)
- Test concentrations with justification for top dose:
- Without S9 mix 0 313 625 1250 2500 &5000 ug/plate
With S9 mix 0 313 625 1250 2500 & 5000 ug/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: Substance is soluble in acetone.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- furylfuramide
- Remarks:
- TA100, TA98 in absence of S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 in absence of S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- WP2 in absence of S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 in absence of S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All strains in the presence of S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Preincubation period: 10h
- Exposure duration: 48h at 37 degrees C
- Expression time (cells in growth medium): 48h
- Selection time (if incubation with a selection agent): N/A
- Fixation time (start of exposure up to fixation or harvest of cells): N/A
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: plates/test: 3
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: not observed at doses of up to 5000 ug/plate with or without S9 - Evaluation criteria:
- An increase in colony count of more than 2 fold when compared with concurrent controls and/or a dose dependent increase in the colony count which is statistically significantly higher than the count for the controls.
- Statistics:
- No statistical analyses were done.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No
- Effects of osmolality: No
- Evaporation from medium: No data
- Water solubility: N/A
- Precipitation: No
- Other confounding effects: No
RANGE-FINDING/SCREENING STUDIES: yes range of doses tested 1.22-5000ug/plate.
COMPARISON WITH HISTORICAL CONTROL DATA:
ADDITIONAL INFORMATION ON CYTOTOXICITY: Toxicity was not observed at 313-5000 ug/plate - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1 - Results of reverse mutation test I
With (+) or |
Dose (µg/plate) |
Number of revertants Mean (±SD) |
||||
without(-) |
Base-pair substitution type |
Frameshift type |
||||
S9 mix |
TA100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
|
|
0 |
105 (±3) |
15 (±5) |
34 (±4) |
23 (±4) |
9 (±2) |
|
313 |
106 (±6) |
17 (±4) |
33 (±7) |
23 (±4) |
10 (±2) |
S9 mix |
625 |
113 (±7) |
20 (±5) |
38 (±2) |
25 (±4) |
8 (±1) |
(-) |
1250 |
124 (±16) |
19 (±3) |
38 (±6) |
28 (±5) |
10 (±1) |
|
2500 |
123 (±12) |
21 (±2) |
36 (±6) |
26 (±2) |
8 (±2) |
|
5000 |
116 (±9) |
23 (±1) |
36 (±3) |
25 (±8) |
8 (±3) |
|
0 |
107 (±8) |
16 (±1) |
29 (±5) |
35 (±3) |
11 (±3) |
|
313 |
114 (±8) |
17 (±2) |
35 (±2) |
31 (±3) |
13 (±3) |
S9 mix |
625 |
115 (±12) |
20 (±2) |
42 (±2) |
35 (±2) |
11 (±1) |
(+) |
1250 |
116 (±10) |
20 (±1) |
43 (±5) |
39 (±3) |
12 (±0) |
|
2500 |
125 (±18) |
21 (±3) |
34 (±3) |
36 (±3) |
11 (±1) |
|
5000 |
131 (±24) |
21 (±3) |
37 (±3) |
39 (±3) |
12 (±2) |
+ve control |
Chemical |
AF-2 |
SA |
ENNG |
AF-2 |
9-AA |
S9 mix(-) |
Doseµg/plate |
0.01 |
0.5 |
2 |
0.1 |
80 |
|
Colonies/plate |
514 (±14) |
441 (±30) |
833 (± 42) |
549 (±40) |
313 (±6) |
+ve control |
Chemical |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
S9 mix(+) |
Doseµg/plate |
1 |
2 |
10 |
0.5 |
2 |
|
Colonies/plate |
1301 (±82) |
228 (±3) |
1092 (±28) |
461 (±10) |
189 (±13) |
AF-2 = 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide; SA = sodium azide; ENNG = N-ethyl-n’-nitro-N-nitrosoguanidine; 9-AA = 9-aminoacridine; 2 -AA = 2 -aminoanthracene
Table 2 - Results of reverse mutation test II
With (+) or |
Dose (µg/plate) |
Number of revertants Mean (±SD) |
||||
without(-) |
Base-pair substitution type |
Frameshift type |
||||
S9 mix |
TA100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
|
|
0 |
151 (±5) |
11 (±2) |
33 (±2) |
20 (±3) |
8 (±2) |
|
313 |
130 (±6) |
10 (±1) |
41 (±5) |
18 (±2) |
8 (±1) |
S9 mix |
625 |
135 (±3) |
10 (±1) |
39 (±2) |
21 (±5) |
7 (±2) |
(-) |
1250 |
135 (±13) |
10 (±3) |
39 (±7) |
17 (±2) |
9 (±3) |
|
2500 |
142 (±6) |
10 (±1) |
42 (±1) |
19 (±2) |
11 (±1) |
|
5000 |
140 (±20) |
9 (±1) |
41 (±1) |
18 (±1) |
8 (±1) |
|
0 |
111 (±6) |
10 (±1) |
40 (±3) |
28 (±2) |
17 (±2) |
|
313 |
135 (±13) |
10 (±2) |
48 (±3) |
26 (±3) |
13 (±2) |
S9 mix |
625 |
151 (±17) |
10 (±1) |
45 (±8) |
29 (±5) |
16 (±3) |
(+) |
1250 |
135 (±24) |
12 (±1) |
45 (±7) |
30 (±4) |
13 (±4) |
|
2500 |
146 (±8) |
10 (±1) |
41 (±4) |
31 (±10) |
16 (±4) |
|
5000 |
140 (±5) |
12 (±2) |
39 (±2) |
29 (±3) |
13 (±3) |
+ve control |
Chemical |
AF-2 |
SA |
ENNG |
AF-2 |
9-AA |
S9 mix(-) |
Doseµg/plate |
0.01 |
0.5 |
2 |
0.1 |
80 |
|
Colonies/plate |
633 (±27) |
485 (±8) |
929 (±39) |
531 (±53) |
436 (±15) |
+ve control |
Chemical |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
S9 mix(+) |
Doseµg/plate |
1 |
2 |
10 |
0.5 |
2 |
|
Colonies/plate |
1230 (±38) |
250 (±2) |
1305 (±68) |
510 (±19) |
190 (±27) |
AF-2 = 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide; SA = sodium azide; ENNG = N-ethyl-n’-nitro-N-nitrosoguanidine; 9-AA = 9-aminoacridine; 2 -AA = 2 -aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on results under the conditions of this test the substance was not considered to be mutagenic to Salmonella typhimurium TA100, TA 1535, TA98, TA1537 & E coli WP2 uvrA. - Executive summary:
A bacterial reverse mutation assay (Ames test) has been undertaken following OECD test methods.
The substance does not induce reverse mutation in Salmonella typhimurium or Escherichia coli.
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