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EC number: 500-066-5 | CAS number: 28961-43-5 1 - 6.5 moles ethoxylated
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 07, 2005 to February 17, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study is according to OECD Guideline 476 and EU Method B.17 in compliance with Good Laboratory Practices of UK
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 2000/32/EC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: United Kingdom Environmental Mutagen Society
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to UK GLP
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
Test material
- Reference substance name:
- Propylidynetrimethanol, ethoxylated, esters with acrylic acid
- EC Number:
- 500-066-5
- EC Name:
- Propylidynetrimethanol, ethoxylated, esters with acrylic acid
- Cas Number:
- 28961-43-5
- Molecular formula:
- n.a.
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-[(1-oxo-2- propenyl)oxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)
- Reference substance name:
- ethoxylated trimethylolpropane triacrylate (TMPeoTA)
- IUPAC Name:
- ethoxylated trimethylolpropane triacrylate (TMPeoTA)
- Details on test material:
- - Physical state: Clear colourless slightly viscous liquid
- Lot/batch No.: 5010121200
- Storage condition of test material: Stored at room temperature in the dark
Constituent 1
Constituent 2
Method
- Target gene:
- Thymidine Kinase (TK)
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The L5178Y TK+/- 3.7.2c mouse lymphoma cell line was obtained from Dr J Cole of the MRC Cell Mutation Unit at the University of Sussex, Brighton, UK.
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: Yes
- Periodically checked for karyotype stability: Yes
- Periodically "cleansed" against high spontaneous background: Yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Pβ/PNF S9 (2% )
- Test concentrations with justification for top dose:
- Preliminary toxicity test:
- 4 h without S9: 0, 0.16, 0.31, 0.63, 1.25, 2.5, 5, 10, 20 and 40 µg/mL
- 4 h with S9: 0, 19.53, 39.06, 78.13, 156.25, 312.5, 625, 1250, 2500 and 5000 µg/mL
- 24 h without S9: 0, 0.08, 0.16, 0.31, 0.63, 1.25, 2.5, 5, 10 and 20 µg/mL
Mutagenicity test:
Experiment 1:
- Without S9: 0, 0.13, 0.25, 0.5, 1, 2, 3, 4 and 5 µg/mL;
- With S9: 0, 1.25, 2.5, 5, 7.5, 10, 20, 30, 40, 50 and 60 µg/mL
Experiment 2:
- Without S9: 0, 0.13, 0.25, 0.5, 1, 2, 3, 4 and 5 µg/mL;
- With S9: 0, 10, 20, 30, 35, 40, 45, 50 and 55 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- absence of metabolic activation Migrated to IUCLID6: 400 µg/mL
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- presence of metabolic activation Migrated to IUCLID6: 1.25 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In suspension
DURATION
-Exposure duration: 24 h
Preliminary study:
- Expression duration- Preliminary test: 4 h (with and without S9); 24 h (without S9)
- Fixation time (start of exposure up to fixation or harvest of cells): 24- 48 h
Experiment 1: 4 h incubation
Experiment 2: 48 h incubation
- Expression time (cells in growth medium): 48 h
SELECTION AGENT (mutation assays): 5-trifluorothymidine (TFT)
STAIN (for cytogenetic assays): MTT solution
NUMBER OF REPLICATIONS: Two - Evaluation criteria:
- - Vehicle control values greater than 250 x 10(-6) mutant frequency per survivor are not normally acceptable and will be repeated.
- Positive control chemicals should induce at least three to five fold increases in mutant frequency greater than the corresponding vehicle control.
- Any test material dose level that has a mutation frequency value that is greater than the corresponding vehicle control by the Global Evaluation Factor (GEF) of 126 x 10(-6) will be considered positive. - Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No
RANGE-FINDING/SCREENING STUDIES: The dose range in the preliminary toxicity test was 0.16 to 40 µg/mL in the 4 h without S9 cultures, 19.53 to 5000 µg/mL in the 4 h with S9 cultures and 0.08 to 20 µg/mL in the 24 h without S9 cultures.
Maximum dose levels were selected using the following criteria:
i) Maximum recommended dose level, 5000 µg/mL or 10 mM.
ii) The presence of excessive precipitate where no test material-induced toxicity was observed.
iii) Test material-induced toxicity, where the maximum dose level used should produce 10 to 20% survival (the maximum level of toxicity required).
As the test material produced cytotoxicity, therefore, criteria (iii) was used for dose selection in the main study.
RESULT DETAILS: IRR 560 induced weak but reproducible toxicologically significant dose-related increases in the mutant frequency both with and without metabolic activation, in the first and second experiment. The mutagenic response was only observed in dose levels approaching the limit of acceptable toxicity. The increase in mutant frequency was predominantly due to small colony formation, indicating clastogenic activity resulting in structural chromosome damage.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- A study was conducted to assess the mutagenic potential of the test substance on the thymidine kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line. The study was conducted according to OECD Guideline 476 and EU Method B.17 in compliance with principles of GLP UK. L5178Y TK +/- 3.7.2c mouse lymphoma cells (heterozygous at the thymidine kinase locus) were treated with the test substance at up to ten dose levels, in duplicate, together with vehicle (solvent) and positive controls. The entire experiment was repeated to confirm the result of the first experiment. 4 h exposures were used both with and without activation in Experiment 1 and Experiment 2.
The test substance induced weak but reproducible toxicologically significant dose-related increases in the mutant frequency both with and without metabolic activation, in the first and second experiment. The mutagenic response was only observed in dose levels approaching the limit of acceptable toxicity. The increase in mutant frequency was predominantly due to small colony formation, indicating clastogenic activity resulting in structural chromosome damage.
In conclusion, the test substance was considered to be mutagenic to L5178Y cells with and without metabolic activation. - Executive summary:
A study was conducted to assess the mutagenic potential of the test substance on the thymidine kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line. The study was conducted according to OECD Guideline 476 and EU Method B.17 in compliance with principles of GLP UK. L5178Y TK +/- 3.7.2c mouse lymphoma cells (heterozygous at the thymidine kinase locus) were treated with the test substance at up to ten dose levels, in duplicate, together with vehicle (solvent) and positive controls. The entire experiment was repeated to confirm the result of the first experiment. 4 h exposures were used both with and without activation in Experiment 1 and Experiment 2.
The dose range of the test substance, plated for expression of mutant colonies, was selected following the results of a preliminary toxicity test and was 0.13 to 4 µg/mL without activation and 7.5 to 50 µg/mL with activation for the first experiment. For the second experiment the dose range was 0.13 to 5 µg/mL without activation and 10 to 55 µg/mL with activation.
The maximum dose level used was limited by the test substance induced toxicity. No precipitate of the test substance was observed at any of the dose levels. The vehicle (solvent) controls had acceptable mutant frequency values that were within the normal range for the L5178Y cell line at the TK +/- locus. The positive control materials induced marked increases in the mutant frequency indicating the satisfactory performance of the test and of the activity of the metabolising system.
The test substance induced weak but reproducible toxicologically significant dose-related increases in the mutant frequency both with and without metabolic activation, in the first and second experiment. The mutagenic response was only observed in dose levels approaching the limit of acceptable toxicity. The increase in mutant frequency was predominantly due to small colony formation, indicating clastogenic activity resulting in structural chromosome damage.
In conclusion, the test substance was considered to be mutagenic to L5178Y cells with and without metabolic activation.
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