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EC number: 629-850-6 | CAS number: 1245638-61-2
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:
- March 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to standard guidelines (with deviations).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Recommended set of five strains not used; duplicate/triplicate plating not used with all strains
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-Propenoic acid, reaction products with pentaerythritol
- EC Number:
- 629-850-6
- Cas Number:
- 1245638-61-2
- Molecular formula:
- Not available for this UVCB.
- IUPAC Name:
- 2-Propenoic acid, reaction products with pentaerythritol
- Details on test material:
- - Name of test material (as cited in study report): SN-1738 pentaerythritol triacrylate
- Physical state: Clear viscous liquid
Constituent 1
Method
- Target gene:
- Not applicable
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):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- Saccharomyces cerevisiae
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: strain D4
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver
- Test concentrations with justification for top dose:
- 0.1, 1, 5 and 10 µL/plate
- Vehicle / solvent:
- No data
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- solvent
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Anthramine, 2-Acetylaminofluorene, 8-Aminoquinoline, Dimethylnitrosamine
- Remarks:
- with metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- solvent
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Methylnitrosoguanidine, 2-Nitrofluorene, Quinacrine mustard
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48-72 h at 37 °C
NUMBER OF CELLS EVALUATED: 10^9
NUMBER OF REPLICATIONS: Single plate/dose, no replication - Evaluation criteria:
- - Dose-related increases in mutant counts were considered as an indication of mutagenicity
- Mutant increases at only one or two doses may be significant if they occur at the higher doses
- Increases at low or intermediate concentrations followed by reduced mutant counts at higher doses may indicate that the test chemical has a narrow activity range or that the high dose levels were toxic and the induced revertant cells were killed - Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 10 µL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- 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:
- at 10 µL for all strains except TA-100
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- Saccharomyces cerevisiae
- 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:
- INTERPRETATION OF RESULTS AND CONCLUSIONS
The test substance, was examined for mutagenic activity in a series of in vitro microbial assays employing Salmonella and Saccharomyces indicator organisms. The test substance was tested directly and in the presence of liver microsomal enzyme preparations from Aroclor-induced rats.
The following results were obtained:
A. Toxicity
The test substance was tested over a series of concentrations such that there was evidence of some chemically-induced physiological effects at the high dose level. The low dose in all cases was below a concentration that demonstrated any toxic effect. The dose range employed for the evaluation of this test substance was 0.1 µL to 10 µL per plate. A considerably high toxicity level was observed at the high dose level for all strains except TA-100 and D4.
B. Non-activation Test Results
The results of the tests conducted on the test substance in the absence of a metabolic system were all negative.
C. Activation Test Results
The results of the tests conducted on the test substance in the presence of the rat liver activation system were all negative. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The substance was negative for mutagenicity (with or without metabolic activation) under the conditions of this Ames test. - Executive summary:
An Ames test was performed to determine the mutagenicity potential of SN-1738 pentaerythritol triacrylate.
Saccharomyces cerevisiae, strain D4 and Salmonella typhimurium strains TA1535, 1537, 1538, 98 and 100 were treated with the substance using the plate incorporation method at four dose levels (0.1, 1, 5 and 10 µL/plate) both with and without metabolic activation (1254 -Aroclor-induced rat liver). A considerably high toxicity level was observed at the high dose level for all strains except TA-100 and D4. Concurrent strain-specific positive and solvent controls, both with and without metabolic activation, were included in each assay.
The results of the tests conducted in the absence and presence of a metabolic activation system were negative.
In conclusion , the substance was not mutagenic under the conditions of this Ames test.
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