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EC number: 290-754-9 | CAS number: 90218-76-1
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:
- 1987-05-12 to 1987-06-22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (only three Salmonella typhimurium strains tested)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,2,4-Benzenetricarboxylic acid, decyl octyl ester
- EC Number:
- 268-007-3
- EC Name:
- 1,2,4-Benzenetricarboxylic acid, decyl octyl ester
- Cas Number:
- 67989-23-5
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- 1,2,4-Benzenetricarboxylic acid, decyl octyl ester
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): WITAMOL 218
- Substance type: product
- Physical state: liquid
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Additional strain / cell type characteristics:
- other: histidine auxotrophe
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: histidine auxotroph
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: histidine auxotroph
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver post-mitochondrial fraction (S9) from Arochlor-1254 induced male Wistar rats
- Test concentrations with justification for top dose:
- 0, 8, 40, 200, 1000 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethylsulfoxide (DMSO)
- Justification for choice of solvent/vehicle: not stated
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-nitrofluorene (50 µg/plate) for TA 98; sodium azide (2 µg/plate) for TA 100; 9-aminoacridine (50 µg/plate) for TA 97
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (5 µg/plate) with all strains
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Preincubation period: not applicable
- Exposure duration: 2 days
NUMBER OF REPLICATIONS: 3 (test substance), 5 (controls)
DETERMINATION OF CYTOTOXICITY
- Method: other: the background lawn was inspected for signs of toxicity (no further details mentioned)
OTHER:
- Colony counting: Colonies were counted electronically using a 40-10 image analyser (Analytical Measuring Systems). - Evaluation criteria:
- - Validity criteria: a) negative control within the normal range, b) clear induced increase in revertant numbers by the positive control confirming discrimination between different strains and an active S9 preparation and c) no more than 5% loss of the plates due to contamination or unforeseen event
- Evaluation criteria: the test compound is considered mutagenic if a) the assay is valid and b) if it induces a two-fold and significant increase in revertant numbers, accompanied by dose response correlations - Statistics:
- Analysis of variance (the F-test) and regression analysis were performed
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- 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:
- no cytotoxicity
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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: at 5000 µg/plate, this did not affect scoring of mutant colonies
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: An initial toxicity range-finding experiment was carried out in TA 100 only, using final concentrations at 8, 40, 200, 1000 and 5000 µg/plate plus a solvent and positive control. From these test results the highest test dose were chosen for the main mutation assay. There were no signs of toxicity up to 5000 µg/plate either in the absence and presence of S9.
COMPARISON WITH HISTORICAL CONTROL DATA: yes, the mean solvent control counts fell within the normal historical range.
ADDITIONAL INFORMATION ON CYTOTOXICITY: no cytotoxicity up to 5000 µg/plate in all strains - Remarks on result:
- other: strain/cell type: Salmonella typhimurium
Any other information on results incl. tables
Table #: Number of revertants per plate (mean of 3 (test substance) resp. 5 (control) plates)
|
[Strain TA 97] |
[Strain TA 98] |
[Strain TA 100] |
||||||
Conc. |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
0* |
85.4 |
157.4 |
no |
19.8 |
23.0 |
no |
90.2 |
126.6 |
no |
8 |
76.7 |
143.7 |
no |
15.7 |
22.7 |
no |
82.3 |
125.3 |
no |
40 |
83.0 |
137.7 |
no |
24.3 |
33.0 |
no |
97.0 |
140.0 |
no |
200 |
80.0 |
159.0 |
no |
22.3 |
29.7 |
no |
93.0 |
136.7 |
no |
1000 |
79.7 |
154.3 |
no |
19.0 |
28.7 |
no |
93.0 |
126.7 |
no |
5000 |
86.7** |
140.3** |
no |
15.7** |
32.7** |
no |
95.0** |
120.7** |
no |
Positive control |
484.6 |
520.6 |
no |
1224.2 |
940.8 |
no |
536.0 |
675.8 |
no |
*solvent control with DMSO ** precipitate observed
Applicant's summary and conclusion
- Conclusions:
- The test item failed to induce a two-fold increase in revertants numbers with any tester strain either in the absence or presence of S-9, so were considered non-mutagenic in this assay.
- Executive summary:
1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was tested for mutation in three histidine requiring strains (TA97, TA98 and TA100) of Salmonella typhimurium both in the absence and presence of metabolic activation by an Aroclor 1254 induced rat liver post-mitochondrial fraction (S9).
An initial toxicity range-finder experiment was carried out in TA100 only, using final concentratios of the test substance at 8, 40, 200, 1000 and 5000 µg/plate plus a solvent and positive control. From these results the highest test dose were chosen for the main mutation assay. In the mutation assay bacteria were tested with up to 50000 µg/plate of the test compound. Negative (solvent) and positive control treatments were included for all strains. The mean numbers of revertant colonies plated all fell within acceptable ranges, and were significantly elevated by positive control treatments.
1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters failed to induce a two-fold increase in revertant numbers with any tester strain either in the absence or presence of S9, so was considered non-mutagenic in this assy.
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