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EC number: 285-550-1 | CAS number: 85116-97-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no S. typhimurium TA102 or E. coli strain was included
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C16-18, esters with ethylene glycol
- EC Number:
- 292-932-1
- EC Name:
- Fatty acids, C16-18, esters with ethylene glycol
- Cas Number:
- 91031-31-1
- Molecular formula:
- C18H36O3, C20H40O3, C34H66O2, C36H70O4, C38H74O2
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537 and TA1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- First and second experiment: 8, 40, 200, 1000 and 5000 µg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween 80; 1:1 (w/w); dilution to desired test concentrations with water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- untreated suspension
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tween 80/bidist. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without S9: sodium azide (2 µg/plate) for TA100 and TA1535; 9-aminoacridine (80 µg/plate) for TA1537; 4-nitro-o-phenylendiamine (40 µg/plate) for TA98 and TA1538
- Untreated negative controls:
- yes
- Remarks:
- untreatred suspension
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tween 80/bidist. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with S9: 2-aminoanthracene (2.5 µg/plate) for TA1535 and TA1537; (5 µg/plate) for TA98, TA100 and TA1538
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- A combination of the following criteria was considered as a positive result: the plate background of non-reverted bacteria did not show any growth reduction versus the respective negative controls; the spontaneous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range; as a rule, the positive controls showed mutation rates exceeding the control values of TA 100 at least by the factor 2.0 and those of the other tester strains at least by the factor 3.03; at more than one dose tested, the test substance caused at least a 2.0-fold increase in comparison with the negative controls in the tester strain TA 100. For the other tester strains, an increase in the mutation rate of more than 3.0 above the corresponding negative controls was considered positive.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: noted at concentrations of 5000 µg/plate
Any other information on results incl. tables
Table 1: Maximum revertants of both experimental series
|
Maximum number of revertants (dose level in µg/mL) |
|||||
solvent control |
positive control |
test substance |
||||
Strain |
With S9 |
Without S9 |
With S9 |
Without S9 |
With S9 |
Without S9 |
TA 98 |
45.0 |
25 |
1218 |
643 |
46.7 (1000) |
24.3 (1000) |
TA 100 |
132.7 |
111 |
936.7 |
318.0 |
122.3 (1000) |
115.0 (1000) |
TA 1535 |
19.0 |
12.3 |
274.0 |
384.0 |
15.0 (1000) |
13.0 (200) |
TA 1537 |
11.3 |
9.3 |
124.7 |
955.3 |
13.3 (200) |
11.3 (1000) |
TA 1538 |
18.7 |
9.0 |
1499.7 |
1678.0 |
24.3 (200) |
10.7 (40) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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