Registration Dossier
Registration Dossier
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EC number: 947-787-5 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- 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'.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- 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.
| 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety evaluation of a medium- and long-chain triacylglycerol oil produced from medium-chain triacylglycerols and edible vegetable oil
- Author:
- Matulka RA, Noguchi O, Nosaka N
- Year:
- 2 006
- Bibliographic source:
- Food and Chemical Toxicology 44:1530-1538
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Oleic acid
- EC Number:
- 204-007-1
- EC Name:
- Oleic acid
- Cas Number:
- 112-80-1
- Molecular formula:
- C18H34O2
- IUPAC Name:
- octadec-9-enoic acid
- Reference substance name:
- Linoleic acid
- EC Number:
- 200-470-9
- EC Name:
- Linoleic acid
- Cas Number:
- 60-33-3
- Molecular formula:
- C18H32O2
- IUPAC Name:
- octadeca-9,12-dienoic acid
- Reference substance name:
- Octanoic acid
- EC Number:
- 204-677-5
- EC Name:
- Octanoic acid
- Cas Number:
- 334-48-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- Caprylic acid
- Reference substance name:
- Linolenic acid
- EC Number:
- 207-334-8
- EC Name:
- Linolenic acid
- Cas Number:
- 463-40-1
- Molecular formula:
- C18H30O2
- IUPAC Name:
- octadeca-9,12,15-trienoic acid
- Reference substance name:
- Palmitic acid
- EC Number:
- 200-312-9
- EC Name:
- Palmitic acid
- Cas Number:
- 57-10-3
- Molecular formula:
- C16H32O2
- IUPAC Name:
- palmitic acid
- Reference substance name:
- Capric acid
- IUPAC Name:
- Capric acid
- Reference substance name:
- Stearic acid
- EC Number:
- 200-313-4
- EC Name:
- Stearic acid
- Cas Number:
- 57-11-4
- Molecular formula:
- C18H36O2
- IUPAC Name:
- stearic acid
- Reference substance name:
- Other fatty acids
- Molecular formula:
- Not available
- IUPAC Name:
- Other fatty acids
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
- 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%)
Method
Species / strainopen allclose all
- 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
Controls
- 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.
Results and discussion
Test resultsopen allclose all
- 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
Any other information on results incl. tables
| 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
Applicant's summary and conclusion
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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