Registration Dossier
Registration Dossier
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EC number: 246-073-4 | CAS number: 24199-46-0
Toxicological information
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 6-methylhept-5-en-2-one
- EC Number:
- 203-816-7
- EC Name:
- 6-methylhept-5-en-2-one
- Cas Number:
- 110-93-0
- IUPAC Name:
- 6-methylhept-5-en-2-one
- Details on test material:
- - Name of test material (as cited in study report): 6-Methylhept-5-en-2-one (Methylheptenon)
- Test substance No.: 00/0874-1
- Physical state: colorless to yellowish liquid
- Analytical purity: 99.1%
- Purity test date: December 28, 2000
- Lot/batch No.: Continuous production
- Date of manufacture: November 14, 2000
- Storage condition of test material: refrigerator (N2 conditions)
The stability of the test substance throughout the study period was not determined analytically. However the characterization was performed from December 21, 2001 to January 18, 2002, whereas the study was conducted from January 23, 2002 (1st experiment) to February 28, 2002 (last experiment). Thus it can be assumed that the test substance was stable throughout the study period.
Constituent 1
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:
- Aroclor 1254 induced rat liver S9 mix
- Test concentrations with justification for top dose:
- 20, 100, 500, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, DMSO was selected as the vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 2.5 µg/plate, dissolved in DMSO; for TA1535, TA 100, TA 1537, TA 98; 60 µg/plate, dissolved in DMSO; for E. coli WP2 uvrA
- Remarks:
- with metabolic activation
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 5 µg/plate, dissolved in DMSO; for TA 1535, TA 100
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamine, 10 µg/plate, dissolved in DMSO; for TA 98
- Remarks:
- without metabolic activation
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 100 µg/plate, dissolved in DMSO; for TA 1537
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 5 pg/plate, dissolved in DMSO; for E. coli WP2 uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
The experimental procedure is based on the method described by Yahagi et al. (1977) and Matsushima et al. (1980).
1ST EXPERIMENT: in agar (plate incorporation) (SPT)
DURATION
- Exposure duration: 48 - 72 h, 37°C
2ND and 3RD EXPERIMENT: preincubation (PIT)
DURATION
- Preincubation period: 20 min, 37°C
- Exposure duration: 48 - 72 h, 37°C
NUMBER OF REPLICATIONS: triplicates; 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants, clearing or diminution of the background lawn (= reduced his- or trp- background growth), reduction in the titer - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
- A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
- The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other.
Results and discussion
Test resultsopen allclose all
- 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:
- other: > 2,500 µg/plate (SPT); > 1,000 - 2,000 µg/plate (PIT)
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: > 2,500 µg/plate (SPT); > 1,000 - 2,000 µg/plate (PIT)
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
- A weak bacteriotoxic effect (slight decrease in the number of revertants and/or slight reduction in the titer) was occasionally abserved in the standard plate test depending on the strain and test conditions from about 2,500 µg/plate onward.
-In the preincubation assay bacteriotoxicity (reduced background growth, decrease in the number of revertants, reduction in the titer) was observed depending an the strain and test conditions from about 1,000 µg - 2,000 µg/plate onward.
Any other information on results incl. tables
STABILITY OF THE TEST SUBSTANCE PREPARATION:
Has been verified at room temperature in the vehicle DMSO over a period of 4 hours.
SOLUBILITY
No test substance precipitation was found.
TOXICITY
A weak bacteriotoxic effect (slight decrease in the number of revertants and/or slight reduction in the titer) was
occasionally observed in the standard plate test depending on the strain and test conditions from about 2,500 µg/plate onward. In the preincubation assay bacteriotoxicity (reduced background growth, decrease in the number of revertants, reduction in the titer) was observed depending on the strain and test conditions from about 1,000 µg - 2,000 µg/plate onward.
MUTAGENICITY
An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system (see tables below).
REVERSION FREQUENCIES
Results as mean values from 3 plates
MNNG = M-methyl-N'-nitro-N-nitrosoguanidine
AA = 2-aminoanthracene
NQO = 4-nitroquinoline-N-oxide
AAC = 9-aminoacridine
NOPD = 4-nitro-o-phenylendiamine
B = reduced background growth
1st Experiment: Standard plate test
Strain TA 1535 TA 100 TA 1537
Dose (µg) -S-9 +S-9 -S-9 +S-9 -S-9 +S-9
Vehicle 17 18 103 111 10 10
20 18 16 94 121 8 12
100 16 15 100 107 8 14
500 15 14 108 120 13 9
2500 21 16 115 106 11 8
5000 16 13 119 44 9 5
MNNG 556 584
AA 149 1072 169
AAC 488
Strain TA 98 E. coli WP2 uvrA
Dose (µg) -S-9 +S-9 -S-9 +S-9
Vehicle 25 34 26 29
20 32 25 23 25
100 34 27 23 23
500 32 25 22 21
2500 23 24 20 18
5000 17 8 13 18
NOPD 961
AA 613 223
NQO 622
2nd Experiment: Preincubation test
Strain TA 1535 TA 100 TA 1537
Dose (µg) -S-9 +S-9 -S-9 +S-9 -S-9 +S-9
Vehicle 17 18 110 103 8 11
20 16 16 122 109 9 9
100 15 17 116 115 10 10
500 15 13 130 111 7 10
2500 11 3 98 42 6 5
5000 0B 0B 0B 0B 0B 0B
MNNG 554 584
AA 125 581 106
AAC 401
Strain TA 98 E. coli WP2 uvrA
Dose (µg) -S-9 +S-9 -S-9 +S-9
Vehicle 25 31 39 33
20 24 30 31 28
100 20 25 26 30
500 14 22 31 27
2500 10 7 18 9
5000 0B 0B 0B 0B
NOPD 862
AA 674 246
NQO 551
3rd Experiment: Preincubation test
Strain TA 1535 TA 100 TA 1537
Dose (µg) -S-9 +S-9 -S-9 +S-9 -S-9 +S-9
Vehicle 18 16 108 111 9 9
125 14 15 107 100 10 12
250 13 10 97 85 11 11
500 14 10 104 80 8 8
1000 14 12 100 85 7 6
2000 13 9 81 54 4 6
MNNG 1143 1393
AA 214 674 118
AAC 555
Strain TA 98 E. coli WP2 uvrA
Dose (µg) -S-9 +S-9 -S-9 +S9
Vehicle 26 32 31 28
125 24 24 36 28
250 24 25 33 28
500 18 22 31 23
1000 14 18 26 20
2000 12 20 20 11
NOPD 667
AA 574 230
NQO 793
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance 6-methyl-5-en-2-one was not mutagenic in the Ames test under the conditions chosen.
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