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EC number: 279-091-6 | CAS number: 79135-90-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
DURING THIS IN VITRO SALMONELLA/MAMMALIAN-MICROSOME ASSAY NO GENE MUTAGENIC ACTIVITY COULD BE DEMONSTRATED UNDER THE EXPERIMENTAL CONDITIONS REPORTED
In an IN VITRO ESCHERICHIA COLI REVERSE MUTATION ASSAY NO GENE MUTAGENIC ACTIVITY COULD BE DEMONSTRATED UNDER THE EXPERIMENTAL CONDITIONS REPORTED.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- well performed guideline like study with GLP but without confirmation of negative results in a second experiment
- Qualifier:
- according to guideline
- Guideline:
- other: Ames et al, Mutation Res. (1975) 31, 347-364
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- AROCLOR 1254 induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 1.58 / 5 / 15.8 / 50 / 158 / 500 / 1580 and 5000 µg/plate
- Vehicle / solvent:
- DIMETHYLSULFOXIDE
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: methylmethanesulphonate, 9-aminoacridine, 2-nitrofluorene, N-ethyl-N-nitro-N-nitrosoguanidine without metabolic activation; 2-aminoanthracene, benzo(a)pyrene with metabolic activation.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation
NUMBER OF REPLICATIONS: each compound concentration including controls is tested in triplicate, without confirmation of negative results by further testing - Evaluation criteria:
- SPECIAL ATTENTION WAS GIVEN TO A REPRODUCIBLE DOSE-EFFECT RELATIONSHIP.
A MUTAGENIC ACTIVITY WAS ASSUMED IF AT LEAST A TWO FOLD (FOR TA 100: ONE AND HALF FOLD) INCREASE OF THE NUMBER OF INDUCED REVERTANTS WAS OBTAINED IN COMPARISON WITH THE SPONTANEOUS REVERTANTS OF THE CORRESPONDING CONTROLS. - 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- DURING THIS IN VITRO SALMONELLA/MAMMALIAN-MICROSOME ASSAY NO GENE MUTAGENIC ACTIVITY COULD BE DEMONSTRATED UNDER THE EXPERIMENTAL CONDITIONS REPORTED.
- Executive summary:
THE TEST ITEM WAS TESTED FOR DETECTING ITS POTENTIAL GENE MUTAGENIC ACTIVITY ACCORDING TO THE PLATE INCORPORATION METHOD OF AMES ET AL. USING THE SALMONELLA THYPHIMURIUM STRAINS TA 98, TA 100, TA 1535, TA 1537 AND TA 1538.
THE TEST WAS PERFORMED WITH AND WITHOUT LIVER MICROSOMAL ACTIVATION. THE TEST MATERIAL WAS TESTED AT EIGHT CONCENTRATION: 1.58 / 5 / 15.8 / 50 / 158 / 500 / 1580 AND 5000 µg PER PLATE. EACH COMPOUND CONCENTRATION INCLUDING CONTROLS WAS TESTED IN TRIPLICATE.
A VERY SLIGHT PRECIPITATION OF THE TEST MATERIAL WAS OBSERVED AFTER POURING THE CONTENT OF THE TEST TUBE OVER THE SURFACE OF THE SELECTIVE AGAR PLATE AT THE CONCENTRATIONS OF 1580 AND 5000 µg PER PLATE. THE REVERTANTS WERE EASILY RECOGNIZABLE AND THE PLATES COULD BE EVALUATED.
UP TO THE HIGHEST TESTED DOSE, WITH AND WITHOUT MICROSOMAL ACTIVATION, NO RELEVANT INCREASE OF THE REVERTANT COLONY NUMBERS WAS OBTAINED IN ANY SALMONELLA THYPHIMURIUM STRAIN IN COMPARISON WITH THE CORRESPONDING CONTROLS.
NO TOXIC EFFECTS OF THE TEST MATERIAL WERE OBSERVED.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- well performed guideline like study with GLP but without confirmation of negative results in a second experiment
- Qualifier:
- according to guideline
- Guideline:
- other: Green et al, Mutation Res. (1976) 38, 3 - 32
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- AROCLOR 1254 induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 1.58 / 5 / 15.8 / 50 / 158 / 500 / 1580 and 5000 µg/plate
- Vehicle / solvent:
- dimethylsulfoxide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: methylmethanesulphonate, N-ethyl-N-nitro-N-nitrosoguanidine (without metabolic activation); 2-aminoanthracene (with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation
NUMBER OF REPLICATIONS: each compound concentration including controls is tested in triplicate, without confirmation of negative results by further testing - Evaluation criteria:
- SPECIAL ATTENTION WAS GIVEN TO A REPRODUCIBLE DOSE-EFFECT RELATIONSHIP.
A MUTAGENIC ACTIVITY IS ASSUMED IF AT LEAST A TWO FOLD INCREASE OF THE NUMBER OF INDUCED REVERTANTS IS OBTAINED IN COMPARISON WITH THE SPONTANEOUS REVERTANTS OF THE CORRESPONDING CONTROL. - Key result
- 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:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- IN CONCLUSION IT CAN BE STATED THAT DURING THIS IN VITRO ESCHERICHIA COLI REVERSE MUTATION ASSAY NO GENE MUTAGENIC ACTIVITY COULD BE DEMONSTRATED UNDER THE EXPERIMENTAL CONDITIONS REPORTED.
- Executive summary:
THE TEST ITEM WAS TESTED FOR DETECTING ITS POTENTIAL GENE MUTAGENIC ACTIYITY ACCORDING TO THE PLATE INCORPORATION METHOD OF GREEN ET AL, USING THE ESCHERICHIA COLI STRAIN WP2UVRA.
THE TEST WAS PERFORMED WITH AND WITHOUT LIVER MICROSOMAL ACTIYATION. THE TEST MATERIAL WAS TESTED AT EIGHT CONCENTRATIONS: 1.58 / 5 / 15.8 / 50 / 158 / 500 / 1580 AND 5000 µg PER PLATE. EACH COMPOUND CONCENTRATION INCLUDING CONTROLS WAS TESTED IN TRIPLICATE.
A VERY SLIGHT PRECIPITATION OF THE TEST MATERIAL WAS OBSERYED AFTER POURING THE CONTENT OF THE TEST TUBE OVER THE SURFACE OF THE SELECTIYE AGAR PLATE AT THE CONCENTRATIONS OF 1580 AND 5000 µg PER PLATE. THE REVERTANTS WERE EASILY RECOGNIZABLE AND THE PLATES COULD BE EYALUATED.
UP TO THE HIGHEST TESTED DOSE, WITH AND WITHOUT LIVER MICROSOMAL ACTIYATION, NO RELEVANT INCREASE OF THE REVERTANT COLONY NUMBERS WAS OBTAINED IN COMPARISON WITH THE CORRESPONDING CONTROLS.
NO TOXIC EFFECTS OF THE TEST MATERIAL WERE OBSERVED.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
No relevant findings observed
Additional information
Two Bacerial Reverse Mutation Assays were performed to investigate the potential of the test item to induce gene mutations using the following tester strains:
key_471 E. coli_1982_RCC_012385:
Escherichia colistrain WP2 uvrA, with and without metabolic activation.
key_471 S. typhimurium_1982_RCC_012385:
TA 1535, TA 1537, TA 98, TA 100, and 1538, with and without metabolic activation.
Although each of these tests is incomplete (regarding tester strains or confirmation of negative results) the set in its entirety fulfills all requirements of a fully valid study thus allowing the conclusion that the test item exerts no gene mutagenic activity in this test system.
Justification for selection of genetic toxicity endpoint
No single study was selected because in view of minor shortcomings
in all available studies preference is given to the entirety of all
available studies in order to get a fully valid data set.
Short description of key information:
AMES, key_471 E. coli_1982_RCC_012385: negative
AMES, key_471 S. typhimurium_1982_RCC_012385: negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Findings in the bacterial reverse mutation assays do not point to genotoxic properties of the test item.
Thus the substance subject to registration does not meet criteria for classification according to REGULATION (EC) No 1272/2008.
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