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A mixture of Propanoic acid, -1-methyl, 2-hydroxy-, (C12-14)-alkyl ester, Propanoic acid, 2-hydroxy-, 2-(C12-14-alkyloxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester and Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester
EC number: 941-488-3 | CAS number: -
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:
- 2007-05-30 to 2007-06-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- A mixture of Propanoic acid, -1-methyl, 2-hydroxy-, (C12-14)-alkyl ester, Propanoic acid, 2-hydroxy-, 2-(C12-14-alkyloxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester and Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester
- EC Number:
- 941-488-3
- Molecular formula:
- UVCB Substance of nominal composition C18H34O5 - C20H38O5
- IUPAC Name:
- A mixture of Propanoic acid, -1-methyl, 2-hydroxy-, (C12-14)-alkyl ester, Propanoic acid, 2-hydroxy-, 2-(C12-14-alkyloxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester and Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester
- Details on test material:
- - Name of test material (as cited in study report): Stepan-Mild L3
- Physical state: Clear colourless liquid
- Analytical purity: 100%
- Lot/batch No.: 17821-040407
- Expiration date of the lot/batch: 2008-04-04
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark.
Constituent 1
Method
- Target gene:
- Gene of histidine-requiring S. typhimurium bacterial strains resulting in histidine-indpendant strains, and a gene of tryptophan-requiring E.coli bacterial strain resulting in a tryptophan-independent strain.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: rfa: deep rough (defective lipopolysaccharide cellcoat), gal: mutation in the galatose metabolism, chl: mutation in notrate reductase, bio: defective biotin synthesis, uvrB: loss of the excision repair system (deletion of the ultraviolet-repair B gene).
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Dose range finding (+/- S9): 3 to 5000 µg/plate
Ist Expt (+/- S9): 3 - 1000 µg/plate
2nd Expt (+/- S9): 10 - 1000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: not specified
Controls
- Untreated negative controls:
- yes
- Remarks:
- Vehicle, DMSO, only
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO only (negative control)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: See attached document: 07-006A; Positive control data
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: Not applicable
- Exposure duration: 48 h
- Expression time (cells in growth medium): 10E09 cells/mL
- Selection time (if incubation with a selection agent): Not applicable
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: reduction in bacterial background lawn, increase in size of the microcolonies and reduction of revertant colonies - Evaluation criteria:
- A response is considered negative if:
- the total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 and WP2uvrA is not greater than three (3) times the concurrent control.
- the negative response should be reproducible in at least one independently repeated experiment.
A response is considered positive if
- The total number of revertants in tester strain TA100 is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three (3) times the concurrent control.
- In case a positive response will be repeated, the positive response should be reproducible in at least one indepentently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision. - Statistics:
- Not stated.
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:
- cytotoxicity
- Remarks:
- See attached document; 07-006A cytotoxicity data
- 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
- Remarks:
- See attached document; 07-006A cytotoxicity data
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitaion of the test material on the plates was observed at the start of the incubation period at concentrations of 333 µg/plate and upwards and at 1000 µg/plate and upwards at the end of the incubation period.
RANGE-FINDING/SCREENING STUDIES:
The test material was tested up to 5000 µg/plate, +/- S9 in the strains TA100 and WP2uvrA. In tester strain TA100, toxicity was observed at dose levels of 100 µg/plate, with and without S9. With WP2uvrA, no toxicity was observed at any dose levels tested.
COMPARISON WITH HISTORICAL CONTROL DATA:
All control values were within laboratory historical control data ranges confirming that the test conditions were adequate and that the metabolic activation system functioned properly. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
See attached document: 07-006A; Mutagenicity Response Tables
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material is not mutagenic with or without metabolic activiation in bacteria under the conditions of the study. - Executive summary:
The test material dissolved in dimethyl sulfoxide (DMSO) was evaluated in the Salmonella typhimurium (strains TA1535, TA1537, TA98 and TA100) reverse mutation assay and the Escherichia coli (WP2uvrA) reverse mutation assay (with independent repeat) in the absence and presence of phenobarbital and beta-naphthoflavone induced rat liver S9 following OECD 471 and EC B13/14 Guidelines.
In a dose range-finding study the test material was tested up to 5000 µg/plate, +/- S9 in the strains TA100 and WP2uvrA. In tester strain TA100, toxicity was observed at dose levels of 100 µg/plate, with and without S9. With WP2uvrA, no toxicity was observed at any dose levels tested.
The test material precipitated at dose levels of 1000 µg/plate and above.
In the first experiment the test material was tested at a concentration range of 3 to 1000 µg/plate with and without 5% (v/v) S9 in strains TA1535, TA1537 and TA98. Toxicity was only observed in the tester strain TA1535 with and without S9 and in TA1537 without S9.
In the repeat assay with additional parameters the test material was tested in the concentration range 10 to 1000 µg/plate in the absence and presence of 10% (v/v) S9 -mix in strains TA1535, TA1537, TA98 and WP2uvrA and at 3 to 666 µg/plate (+/- S9) in tester strain TA100. Toxicity was observed in tester strains TA1535 without S9, and TA1537 and TA100 with and without S9.
The test material did not induce a signficant dose-related increase in the number of revertant (His+) colonies in each of the four S typhimurium tester strains and in the number of revertant (Trp+) colonies in the E.coli tester strain both with and without S9.
All control values were within laboratory historical control data ranges confirming that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that the test material is not mutagenic in vitro in bacteria with or without metabolic activation.
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