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Diss Factsheets

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (4 tested strains)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
6,10,14-trimethylpentadecan-2-one
EC Number:
207-950-7
EC Name:
6,10,14-trimethylpentadecan-2-one
Cas Number:
502-69-2
Molecular formula:
C18H36O
IUPAC Name:
6,10,14-trimethylpentadecan-2-one
Details on test material:
Hexahydrofarnesylaceton
- purity: 93.4%
- test substance number: 88/596
- storage: room temperature
- complete solubility in DMSO
Specific details on test material used for the study:
Hexahydrofarnesylaceton
Degree of purity: 93.4%

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat S9 (Sprague-Dawley)
Test concentrations with justification for top dose:
0, 20, 100, 500, 2500 and 5000 µg/plate
Vehicle / solvent:
DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (10 µg)
Remarks:
with S9-mix
Positive control substance:
other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG; 5 µg)
Remarks:
for TA 100 and TA 1535 without S9-mix
Positive control substance:
other: 4-nitro-o-phenylendiamine (10 µg)
Remarks:
for TA 98 without S9-mix
Positive control substance:
9-aminoacridine
Remarks:
for TA 1537 without S9-mix Migrated to IUCLID6: 100 µg
Details on test system and experimental conditions:
- test conditions: standard plate test and preincubation test both with and without metabolic activation (S9-mix)
- 3 test plates per dose or per control
Evaluation criteria:
In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
- no increase in the number of his+ revertants in any of the tests
- no bacteriotoxic effect observed

Any other information on results incl. tables

method: SPT
strain: TA 100
  revertants / plate quotient
dose [µg/plate] -S9 mean SD +S9 mean SD -S9 +S9
DMSO 105     125        
115 114 9 106 115 10 1,0 1,0
122     113        
20 104     102      
122 108 12 112 108 6 0,9 0,9
98     111        
100 121     127      
108 115 7 105 111 14 1,0 1,0
116     102        
500 108     92      
118 109 8 115 101 12 1,0 0,9
102     96        
2500 106     98      
109 105 5 108 105 6 0,9 0,9
99     109        
5000 114     125      
111 115 4 112 117 7 1,0 1,0
119     113        
2-AA [10 µg/pl]       1940      
  1700 1827 121 15,9
      1840        
MNNG [5 µg/plate] 1330    
1380 1347 29   11,8  
1330              
method: SPT
strain: TA 98
  revertants / plate quotient
dose [µg/plate] -S9 mean SD +S9 mean SD -S9 +S9
DMSO 20     34        
23 22 2 33 33 2 1,0 1,0
23     31        
20 23     43        
27 24 2 32 36 6 1,1 1,1
23     34        
100 20     37        
20 21 2 41 39 2 1,0 1,2
23     40        
500 21     33        
22 22 2 34 33 2 1,0 1,0
24     31        
2500 17     40        
21 20 3 30 35 5 0,9 1,1
22     34        
5000 21     32        
17 20 2 31 33 3 0,9 1,0
21     36        
2-AA [10 µg/pl]       1370        
  1120 1297 154 39,7
      1400        
NPD [10 µg/plate] 760    
784 810 66   36,8  
885              
method: SPT
strain: TA 1535
  revertants / plate quotient
dose [µg/plate] -S9 mean SD +S9 mean SD -S9 +S9
DMSO 17     20        
22 18 4 15 17 3 1,0 1,0
15     16        
20 17     29      
21 18 3 24 23 7 1,0 1,4
16     16        
100 17     24      
20 21 4 23 23 1 1,1 1,4
25     22        
500 18     0      
20 19 1 16 21 6 1,1 1,2
19     25        
2500 21     20      
17 18 2 14 19 5 1,0 1,1
17     23        
5000 26     17      
16 22 6 19 18 1 1,2 1,1
25     18        
2-AA [10 µg/pl]       181      
  208 193 14 11,4
      191        
MNNG [5 µg/plate] 2250    
2150 2077 219   115,4  
1830              
method: SPT
strain: TA 1537
  revertants / plate quotient
dose [µg/plate] -S9 mean SD +S9 mean SD -S9 +S9
DMSO 8     7        
9 8 1 11 9 2 1,0 1,0
8     8        
20 12     12      
11 11 2 10 11 1 1,3 1,3
9     11        
100 8     14      
8 8 1 12 12 2 1,0 1,4
9     10        
500 6     13      
7 7 1 8 10 3 0,8 1,2
8     9        
2500 6     10      
10 10 4 6 8 2 1,2 1,0
13     9        
5000 6     8      
12 8 4 6 6 2 0,9 0,7
5     5        
2-AA [10 µg/pl]       160      
  189 177 15 20,4
      181        
AAC [100 µg/plate] 604    
719 656 58   78,8  
646              
method: PIT
strain: TA 1535
  revertants / plate quotient
dose [µg/plate] -S9 mean SD +S9 mean SD -S9 +S9
DMSO 18     20        
22 20 2 21 24 6 1,0 1,0
19     30        
20 21     19      
26 22 4 22 20 2 1,1 0,8
19     18        
100 19     34      
22 19 4 22 28 6 0,9 1,2
15     29        
500 12     19      
19 17 4 21 20 1 0,8 0,8
19     19        
2500 20     23      
19 20 1 26 27 4 1,0 1,1
20     31        
5000 15     25      
17 17 3 17 22 4 0,9 0,9
20     23        
2-AA [10 µg/pl]       117      
  140 141 25 6,0
      166        
MNNG [5 µg/plate] 1750    
1500 1567 161   79,7  
1450              
method: PIT
strain: TA 100
  revertants / plate quotient
dose [µg/plate] -S9 mean SD +S9 mean SD -S9 +S9
DMSO 92     105        
107 98 8 99 100 5 1,0 1,0
95     95        
20 102     96      
88 97 8 94 96 2 1,0 1,0
101     97        
100 97     85      
105 104 7 96 93 7 1,1 0,9
110     99        
500 97     94      
90 102 16 102 94 8 1,0 0,9
120     87        
2500 89     87      
112 96 14 94 89 4 1,0 0,9
87     87        
5000 91     75      
104 101 9 80 80 6 1,0 0,8
107     86        
2-AA [10 µg/pl]       1500      
  1350 1417 76 14,2
      1400        
MNNG [5 µg/plate] 1000    
993 1000 7   10,2  
1007              
method: PIT
strain: TA 1537
  revertants / plate quotient
dose [µg/plate] -S9 mean SD +S9 mean SD -S9 +S9
DMSO 6     8        
8 7 1 10 9 1 1,0 1,0
7     8        
20 6     10      
5 5 1 11 10 2 0,8 1,1
5     8        
100 10     9      
5 7 3 9 9 1 1,0 1,1
7     10        
500 6     6      
7 6 1 9 7 2 0,9 0,8
6     5        
2500 8     4      
5 8 3 5 5 2 1,1 0,6
10     7        
5000 6     7      
6 6 1 9 8 1 0,9 0,9
7     8        
2-AA [10 µg/pl]       216      
  211 215 4 24,8
      218        
AAC [100 µg/plate] 646    
638 625 29   89,3  
592              
method: PIT
strain: TA 98
  revertants / plate quotient
dose [µg/plate] -S9 mean SD +S9 mean SD -S9 +S9
DMSO 26     27        
24 23 3 33 29 3 1,0 1,0
20     27        
20 29     27      
23 25 3 26 27 2 1,1 0,9
24     29        
100 20     30      
27 22 5 25 27 3 0,9 0,9
18     25        
500 19     32      
21 21 2 31 30 2 0,9 1,0
23     28        
2500 23     25      
17 20 3 29 30 5 0,9 1,0
21     35        
5000 20     33      
19 20 1 27 29 4 0,9 1,0
21     26        
2-AA [10 µg/pl]       1180      
  1250 1222 37 42,1
      1235        
NPD [10 µg/plate] 1160    
1170 1110 95   47,6  
1000              

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative