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EC number: 224-631-8 | CAS number: 4431-83-8
- Life Cycle description
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Toxicological Summary
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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:
- From 2010-03-26 to 2010-04-26
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according 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:
- 2,5,7,10-tertaoxaudecane
- IUPAC Name:
- 2,5,7,10-tertaoxaudecane
- Details on test material:
- - Name of test material (as cited in study report): 2,5,7,10-tertaoxaudecane (TOU)
- Substance type: colourless liquid
- Physical state:
- Analytical purity: 99.632% (w/w)
- Impurities (identity and concentrations): alcohols (0.064%); aldehydes (not found); water (0.142%)
- Lot/batch No.: 0804061200
- Expiration date of the lot/batch: 06/04/2011
- Storage condition of test material: stored in a glas vial at laboratory temperature during the study
Constituent 1
Method
- Target gene:
- his (trp) locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Nutrient Broth (Merck); Agar-agar (Fluka)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: not specified
- Periodically checked for karyotype stability: yes, genotypes of each strain were controlled (plasmid pKM 101 - ampicillin resistance, uvr mutation, rfa mutation, his/trp mutation - spontaneous reversions)
- Periodically "cleansed" against high spontaneous background: not specified
S. typhimurium strains TA 1537 and TA 98 serve to detect frame shift mutations, strains TA100 and TA 1535 serve to detect base-pair substitution mutations. - Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Nutrient Broth (Merck); Agar-agar (Fluka)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: not specified
- Periodically checked for karyotype stability: yes, genotypes of each strain were controlled (plasmid pKM 101 - ampicillin resistance, uvr mutation, rfa mutation, his/trp mutation - spontaneous reversions)
- Periodically "cleansed" against high spontaneous background: not specified
E. coli strain WP2uvrA serve to detect cross-linking mutagens - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction of rat liver homogenate and mixture of cofactors
- Test concentrations with justification for top dose:
- Toxicity test: 10, 100, 500, 1000, 2500, 5000 µg/plate with TA 100 without metabolic activation
First and second mutation experiments: 50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation
(please refer to details to test system and conditions) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: not specified
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- (whitout solvent)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (contains 0.1 ml ofwater)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: 1.5 µg/plate; TA 100 and TA 1535 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenilenediamine (20 µg/plate;TA 98 without metabolic activation)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminofluorene (10 µg/plate; TA 100 and TA 98 with metabolic activation)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthacene (1.0 µg/plate; TA 1535 - 2.5 µg/plate; TA 1537 - 25 µg/plate; E. coli with metabolic activation)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine hydrochloride monohydrae (100 µg/plate; TA 1537 without metabolic activation)
- 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:
- Migrated to IUCLID6: (20 µg/plate; E. coli without metabolic activation)
- Details on test system and experimental conditions:
- TEST PROCEDURE
100 µl of TOU of required concentration, 0.1 ml 16-18h culture of tester strain, 0.5 ml relevant buffer and 30 or 100 µl ofS9 postmitochondrial fraction were added to the 2 ml top agar (with trace of hisdine or tryptophan) kept in a testtube at 45 +/- 3°C. After shaking the mixture was poured into a minimal glucose agar plate. After incubation of 48-78h at 37+/- 1°C, the number of revertant colonies on the plate was counted manually with exception of positive controls, which were counted by an AccuCount 1000.
For an adequate estimate of variation, triplicate plating was used ateach dose level except in the toxicity test with strain TA100, where the substance was tested in duplicate. Each experiment was repeated0 As there was no toxicity, no precipitation or dose-responsiveness, doses in the second experiments remained the same as in the first experiment. In case of toxicity or precipitation, toxic (precipitating) doses would be omitted0 In case of mutagenicity, such doses would be chosen which allow construction of a dose-response curve.
SELECTION OF DOSE / TOXICITY
The test substance was dissolved in water for injections in the maximum cocentration given in gguidelines (5000 µg/plate).
- The highest concentration was further diluted. The concentration series (10-5000 µg/plate) was tested for toxicity in strain TA100 without metabolic activation.
- The first mutagenicity tests were done with doses of 50, 150, 500, 1500 and 5000 µg/plate.
- The second mutagenicity tests was performed with the same doses than the ones used in first mutagenicity tests.
All concentrations of the test substance suspension were dosed in the volume of 0.1 ml/plate. Fresh suspensions of test substance were prepared before each experiment. The suspensions were shaken during dilution, before dosing to the top agar and before pouring onto the plates. - Evaluation criteria:
- The main criterion for evaluation of results was modified 2-fold increase rule that is compatible with the application of statistical methods. Following application of this rule, the result is positive, if a reproductible dose-response effect occurs and/or a doubling of the ratio of revertants at tested dose to number of revertants at negative doseis reached.
- Statistics:
- Dunkel & Chu (1980), Claxton et al. (1987)
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:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Toxicity test: Precipitation and signs of toxicity were not observed at any dose.
First and second mutagenicity test: The results obtained did not show substantial (biologically significant) increases in the number of revertants versus solvent control and no experiment gave evidence of rising trend in the number of revertants with increasing dose. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the described experimental design, the test substance 2,5,7,10-tertaoxaudecane (TOU) was non mutagenic for all Salmonella typhimurium as well as Escherchia coli strains both in experiments with and without metabolic activation. - Executive summary:
Test substance2,5,7,10-tertaoxaudecane (TOU)was assayed for the mutagenicity by the Bacterial Reverse Mutation Test. The test was performed according to EU method B.13/14 Mutagenicity – Reverse mutation test using bacteria, which is analogous to the OECD Test Guideline No. 471.
Four indicator Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and one indicator Escherchia coli WP2 uvrA strain was used. The test substance was diluted in water and assayed in doses of 50-5000 µg which were applied to plates in volumes of 0.1 mL.
Two series of experiments were performed with each strain – without metabolic activation and with a supernatant of rat liver and a mixture of cofactors.
Under the described experimental design, the test substance 2,5,7,10-tertaoxaudecane (TOU) was non mutagenic for all Salmonella typhimurium as well as Escherchia coli strains both in experiments with and without metabolic activation.
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