Registration Dossier
Registration Dossier
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EC number: 947-787-5 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No information was available on the test substance, therefore read across was used to fill the endpoint. Three in vitro Ames tests were used as read across information. Two were considered reliable with restriction (Klimisch 2), conducted on medium- and long-chain triacylglycerol and oleic acid and one was considered not assignable (Klimisch 4) conducted on glyceryl citrate/lactate/linoleate/oleate. All three Ames tests resulted in no concentration-related increases in revertant colonies/plates in either strain of bacteria, with or without exogenous metabolic activation.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- No strain of E. coli tested
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Not specified.
- Test concentrations with justification for top dose:
- 50 to 5000 µg/plate
- Vehicle / solvent:
- - Solvent(s) used: Tetrahydrofurane
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tetrahydrofurane
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation) and preincubation - Rationale for test conditions:
- Not specified.
- Evaluation criteria:
- Not specified.
- Statistics:
- Not specified.
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- Glyceryl citrate/lactate/linoleate/oleate was not mutagenic in all strains, with or without metabolic activation.
- Executive summary:
The genetic toxicity of the test item was investigated using four strains of Salmonella: TA98, TA100, TA1535 and TA1537. The study followed plate incorporation and preincubation methods, with experiments performed with and without metabolic activation. The study was performed at concentrations ranging from 50 to 5000 µg/plate. Tetrahydrofurane was used as the solvent control, and the three positive controls were 2 -nitrofluorene, sodium azide and 9 -aminoacridine. There were no increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, with or without metabolic activation. Therefore glyceryl citrate/lactate/linoleate/oleate acid was considered to be non-mutagenic.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'. - Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material:
Nisshin Oillo Group, Ltd., Tokyo, Japan
- Composition: Caprylic acid (9.7%), capric acid (3.3%), palmitic acid (3.8%), stearic acid (1.7%), oleic acid (51.2%), linoleic acid (18.4%), linolenic acid (9.0%) and other fatty acids (2.9%) - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- concentration or volume of S9 mix and S9 in the final culture medium: 0.5 ml - Test concentrations with justification for top dose:
- 0, 313, 625, 1250, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: no data - vehicle control used
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: NaN3, AF-2, ICR-191
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 minutes - Rationale for test conditions:
- A preliminary study was conducted.
- Evaluation criteria:
- Not stated.
- Statistics:
- Not stated.
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- Administration of MLCT oil did not result in any concentration-related increases in revertant colonies/plates in either strain of bacteria, with or without exogenous metabolic activation.
- Executive summary:
The genetic toxicity of the test item, a mixture of medium and long-chain triacylglycerols (MLCT) of known composition, was investigated. The study was conducted in triplicate, following plate incorporation methods, with experiments performed with and without metabolic activation. The study was performed at concentrations of 0, 313, 625, 1250, 2500 and 5000 µg/plate. The studies without metabolic activation utilised AF-2 and NaN3 as positive control substances; the studies with metabolic activation utilised Benzo(a)pyrene as positive control substance. Solvent treatment groups were used as the negative control in all experiments. There were no increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, with or without metabolic activation (S9-mix). The vehicle control plates gave counts of revertant colonies within the normal range, and all positive control chemicals induced marked increases in the frequency of revertant colonies with and without metabolic activation. Therefore MLCT was considered to be non-mutagenic.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'. - Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- No strain of E. coli tested
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material:
American Scientific Prod. - Target gene:
- His
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : Male Sprague-Dawley rats and male Syrian hamsters
- method of preparation of S9 mix: The S9 fraction was obtained by centrifugation of the liver homogenate for 10 minutes at 9000 g and 4 degrees celcius
- concentration or volume of S9 mix and S9 in the final culture medium: 0.5 ml - Test concentrations with justification for top dose:
- All doses were chosen based on an initial test with TA1000 over a wide range of concentrations.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: DMSO was chosen for chemicals that were not soluble in water - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenyldiamine; tris(1,2-dichloro-2-propyl)phosphate
- Rationale for test conditions:
- Not stated.
- Evaluation criteria:
- 1) Mutagenic response: A dose-related, reproducible increase in the number of revertants over background;
2) Non-mutagenic response: When no increase in the number of revertants was elicited by the chemical;
3) Questionable response: When there was an absence of a clear-cut dose-related increase in revertants; when the dose-related increases in the number of revertants was not reproducible; or when the response was of insufficient magnitude to support a determination of mutagenicity. - Statistics:
- Not stated.
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Conclusions:
- Administration of oleic acid did not result in any concentration-related increases in revertant colonies/plates in either strain of bacteria, with or without exogenous metabolic activation.
- Executive summary:
The genetic toxicity of the test item, oleic acid, was investigated using four strains of Salmonella: TA98, TA100, TA1535 and TA1537. The study followed plate incorporation methods, with experiments performed with and without metabolic activation. The study was performed at concentrations of 0, 3.3, 10, 33, 100 and 333 µg/plate. Sodium azide was used as a positive control for the TA135 and TA100 strains, 4 -nitro-o-phenylenediamine was used for TA98 and 9 -aminoacridine was used for TA97 and TA 1537. Potasium chloride was used as the negative control in all experiments. There were no increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, with or without metabolic activation (S9-mix). The vehicle control plates gave counts of revertant colonies within the normal range, and all positive control chemicals induced marked increases in the frequency of revertant colonies with and without metabolic activation. Therefore oleic acid was considered to be non-mutagenic.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'. - Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- No strain of E. coli tested
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Not specified.
- Test concentrations with justification for top dose:
- 50 to 5000 µg/plate
- Vehicle / solvent:
- - Solvent(s) used: Tetrahydrofurane
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tetrahydrofurane
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation) and preincubation - Rationale for test conditions:
- Not specified.
- Evaluation criteria:
- Not specified.
- Statistics:
- Not specified.
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- Glyceryl citrate/lactate/linoleate/oleate was not mutagenic in all strains, with or without metabolic activation.
- Executive summary:
The genetic toxicity of the test item was investigated using four strains of Salmonella: TA98, TA100, TA1535 and TA1537. The study followed plate incorporation and preincubation methods, with experiments performed with and without metabolic activation. The study was performed at concentrations ranging from 50 to 5000 µg/plate. Tetrahydrofurane was used as the solvent control, and the three positive controls were 2 -nitrofluorene, sodium azide and 9 -aminoacridine. There were no increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, with or without metabolic activation. Therefore glyceryl citrate/lactate/linoleate/oleate acid was considered to be non-mutagenic.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material:
Nisshin Oillo Group, Ltd., Tokyo, Japan
- Composition: Caprylic acid (9.7%), capric acid (3.3%), palmitic acid (3.8%), stearic acid (1.7%), oleic acid (51.2%), linoleic acid (18.4%), linolenic acid (9.0%) and other fatty acids (2.9%) - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- concentration or volume of S9 mix and S9 in the final culture medium: 0.5 ml - Test concentrations with justification for top dose:
- 0, 313, 625, 1250, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: no data - vehicle control used
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: NaN3, AF-2, ICR-191
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 minutes - Rationale for test conditions:
- A preliminary study was conducted.
- Evaluation criteria:
- Not stated.
- Statistics:
- Not stated.
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- Administration of MLCT oil did not result in any concentration-related increases in revertant colonies/plates in either strain of bacteria, with or without exogenous metabolic activation.
- Executive summary:
The genetic toxicity of the test item, a mixture of medium and long-chain triacylglycerols (MLCT) of known composition, was investigated. The study was conducted in triplicate, following plate incorporation methods, with experiments performed with and without metabolic activation. The study was performed at concentrations of 0, 313, 625, 1250, 2500 and 5000 µg/plate. The studies without metabolic activation utilised AF-2 and NaN3 as positive control substances; the studies with metabolic activation utilised Benzo(a)pyrene as positive control substance. Solvent treatment groups were used as the negative control in all experiments. There were no increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, with or without metabolic activation (S9-mix). The vehicle control plates gave counts of revertant colonies within the normal range, and all positive control chemicals induced marked increases in the frequency of revertant colonies with and without metabolic activation. Therefore MLCT was considered to be non-mutagenic.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- No strain of E. coli tested
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material:
American Scientific Prod. - Target gene:
- His
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : Male Sprague-Dawley rats and male Syrian hamsters
- method of preparation of S9 mix: The S9 fraction was obtained by centrifugation of the liver homogenate for 10 minutes at 9000 g and 4 degrees celcius
- concentration or volume of S9 mix and S9 in the final culture medium: 0.5 ml - Test concentrations with justification for top dose:
- All doses were chosen based on an initial test with TA1000 over a wide range of concentrations.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: DMSO was chosen for chemicals that were not soluble in water - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenyldiamine; tris(1,2-dichloro-2-propyl)phosphate
- Rationale for test conditions:
- Not stated.
- Evaluation criteria:
- 1) Mutagenic response: A dose-related, reproducible increase in the number of revertants over background;
2) Non-mutagenic response: When no increase in the number of revertants was elicited by the chemical;
3) Questionable response: When there was an absence of a clear-cut dose-related increase in revertants; when the dose-related increases in the number of revertants was not reproducible; or when the response was of insufficient magnitude to support a determination of mutagenicity. - Statistics:
- Not stated.
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Conclusions:
- Administration of oleic acid did not result in any concentration-related increases in revertant colonies/plates in either strain of bacteria, with or without exogenous metabolic activation.
- Executive summary:
The genetic toxicity of the test item, oleic acid, was investigated using four strains of Salmonella: TA98, TA100, TA1535 and TA1537. The study followed plate incorporation methods, with experiments performed with and without metabolic activation. The study was performed at concentrations of 0, 3.3, 10, 33, 100 and 333 µg/plate. Sodium azide was used as a positive control for the TA135 and TA100 strains, 4 -nitro-o-phenylenediamine was used for TA98 and 9 -aminoacridine was used for TA97 and TA 1537. Potasium chloride was used as the negative control in all experiments. There were no increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, with or without metabolic activation (S9-mix). The vehicle control plates gave counts of revertant colonies within the normal range, and all positive control chemicals induced marked increases in the frequency of revertant colonies with and without metabolic activation. Therefore oleic acid was considered to be non-mutagenic.
Referenceopen allclose all
| Dose (µg/plate) | ||||||
| Strain | 0 | 313 | 625 | 1250 | 2500 | 5000 |
| TA98 (-) | 24 | 25 | 17 | 17 | 22 | 24 |
| TA100 (-) | 129 | 140 | 123 | 136 | 122 | 136 |
| TA1535 (-) | 21 | 29 | 19 | 23 | 23 | 20 |
| TA1537 (-) | 15 | 13 | 14 | 12 | 16 | 18 |
| WP2uvrA (-) | 23 | 19 | 27 | 22 | 22 | 24 |
| TA98 (+) | 33 | 46 | 35 | 33 | 45 | 42 |
| TA100 (+) | 143 | 140 | 137 | 141 | 130 | 156 |
| TA1535 (+) | 20 | 23 | 21 | 17 | 23 | 20 |
| TA1537 (+) | 27 | 25 | 21 | 22 | 24 | 25 |
| WP2uvrA (+) | 38 | 33 | 39 | 35 | 38 | 35 |
(-) = without metabolic activation; (+) = with metabolic activation
| Dose (µg/plate) | ||||||
| Strain | 0 | 313 | 625 | 1250 | 2500 | 5000 |
| TA98 (-) | 24 | 25 | 17 | 17 | 22 | 24 |
| TA100 (-) | 129 | 140 | 123 | 136 | 122 | 136 |
| TA1535 (-) | 21 | 29 | 19 | 23 | 23 | 20 |
| TA1537 (-) | 15 | 13 | 14 | 12 | 16 | 18 |
| WP2uvrA (-) | 23 | 19 | 27 | 22 | 22 | 24 |
| TA98 (+) | 33 | 46 | 35 | 33 | 45 | 42 |
| TA100 (+) | 143 | 140 | 137 | 141 | 130 | 156 |
| TA1535 (+) | 20 | 23 | 21 | 17 | 23 | 20 |
| TA1537 (+) | 27 | 25 | 21 | 22 | 24 | 25 |
| WP2uvrA (+) | 38 | 33 | 39 | 35 | 38 | 35 |
(-) = without metabolic activation; (+) = with metabolic activation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Three in vitro Ames test studies are available on read-across substances to evaluate the genotoxicity of the test item. Two studies were considered reliable with restriction (Klimisch 2) and sufficient for classification. One study was considered Klimisch 4 and therefore as background information. None of studies indicated any potential for mutagenicity. Consequently, in accordance with the CLP Regulation (EC) No. 1272/2008, the test item is not classified as a genetic toxicant.
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