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EC number: 203-931-2 | CAS number: 112-05-0
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Nonanoic acid
- EC Number:
- 203-931-2
- EC Name:
- Nonanoic acid
- Cas Number:
- 112-05-0
- Molecular formula:
- C9H18O2
- IUPAC Name:
- nonanoic acid
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Pelargonsäure
- Substance type: organic acid
- Physical state: liquid
- Analytical purity: 93% C9 fatty acid
- Lot/batch No.: 799800
Constituent 1
Method
- Target gene:
- histidine operon (Salmonella typhimurium))
tryptophan operon (E. coli)
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:
- S9-mix; contains 9000 g rat liver supernatant from Aroclor 1254 induced Wistar rats
- Test concentrations with justification for top dose:
- 100, 333, 1000, 3330, and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: low water solubility of the test substance
Controls
- Untreated negative controls:
- yes
- Remarks:
- historical controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: sodium azide; 9-aminoacridine; daunomycine; methylmethanesulfonate; 4-nitroquinoline N-oxide. With metabolic activation: 2-aminoanthracene.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 48 hours
SELECTION AGENT (mutation assays): hisitidine (S. typhimurium); tryptophan (E. coli)
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: all colonies
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; relative total growth - Evaluation criteria:
- Inter alia, at least doubling of vehicle control number of revertants in at least one strain, and reproducibility
- Statistics:
- Calculation of means and standard deviation
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: noted at 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES: yes
COMPARISON WITH HISTORICAL CONTROL DATA: yes
ADDITIONAL INFORMATION ON CYTOTOXICITY: strain-dependent reduction of treh number of revertant colonies was not from 1000 µg/plate onwards (cf. below)
Any other information on results incl. tables
Results of experiment 1 (empty cells: strains not examined)
Concentration [µg/plate] |
Metabol activation1 |
Revertants/plate [mean of 3 plates] |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli |
||
DMSO |
- |
16±2 |
n.d. |
13±2 |
6±2 |
n.d. |
100 |
- |
18±7 |
n.d. |
11±2 |
7±1 |
n.d. |
333 |
- |
15±2 |
n.d. |
12±4 |
6±2 |
n.d. |
1000 |
- |
13±1 |
n.d. |
11±1 |
5±1 |
n.d. |
3333 |
- |
9±2 |
n.d. |
11±5 |
2±1 |
n.d. |
5000 |
- |
7±2 |
n.d. |
12±6 |
MC ³ |
n.d. |
Pos. control |
- |
239±71 |
n.d. |
138±5 |
174±10 |
n.d. |
|
||||||
DMSO |
+ |
23±4 |
n.d. |
13±1 |
5±1 |
n.d. |
100 |
+ |
20±5 |
n.d. |
12±1 |
6±2 |
n.d. |
333 |
+ |
25±6 |
n.d. |
9±2 |
6±3 |
n.d. |
1000 |
+ |
15±3 |
n.d. |
10±2 |
4±15 |
n.d. |
3333 |
+ |
16±1 |
n.d. |
7±1 |
1±1 |
n.d. |
5000 |
+ |
11±3 |
n.d. |
11±3 |
MC ³ |
n.d. |
Pos. control |
+ |
419±25 |
n.d. |
138±5 |
418±57 |
n.d. |
MC Microcolonies
1 the S9-mix contained 5% S9 fraction
² background lawn slightly reduced
³ background lawn extremely reduced
n.d. not determined
Results of experiment 2
Concentration [µg/plate] |
Metabol activation1 |
Revertants/plate [mean of 3 plates] |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli |
||
DMSO |
- |
18±1 |
99±10 |
11±2 |
8±3 |
15±5 |
100 |
- |
17±2 |
90±12 |
13±4 |
9±4 |
13±4 |
333 |
- |
18±6 |
81±3 |
13±4 |
6±4 |
10±1 |
1000 |
- |
17±5 |
70±13 |
6±1 |
6±3 |
12±5 |
3333 |
- |
8±4 |
55±5 |
9±3 |
1±2 |
9±4 |
5000 |
- |
5±1 |
5±1 SP |
6±2 ² |
0±0 |
9±2 |
Pos. control |
- |
422±69 |
25±6 ² |
461±24 |
449±58 |
1019±49 |
|
||||||
DMSO |
+ |
23±1 |
79±12 |
14±2 |
7±2 |
15±5 |
100 |
+ |
29±8 |
61±7 |
13±5 |
6±1 |
13±4 |
333 |
+ |
20±2 |
49±13 |
10±1 |
8±3 |
10±1 |
1000 |
+ |
18±5 |
29±2 ² |
13±8 |
6±4 |
12±5 |
3333 |
+ |
14±2 |
13± 2 SP |
7±0 |
2±1 ² |
9±4 |
5000 |
+ |
10±2 |
5±1 SP |
8±3 |
1±1 ² |
9±2 |
Pos. control |
+ |
198±15 |
9±4 ² |
125±28 |
86±18 |
1019±49 |
SP slight precipitate
1 the S9-mix contained 10% S9 fraction
² background lawn slightly reduced
n.d. not determined
Results of experiment 3 (empty cells: strains not examined)
Concentration [µg/plate] |
Metabol activation1 |
Revertants/plate [mean of 3 plates] |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli |
||
DMSO |
- |
27±2 |
n.d. |
15±5 |
5±2 |
12±1 |
1000 |
- |
23±7 |
n.d. |
10±2 |
7±3 |
12±6 |
3333 |
- |
9±3 |
n.d. |
10±6 |
1±1 |
9±5 |
5000 |
- |
9±4SP |
n.d. |
10±3SP |
0±0SP |
7±1SP |
Pos. control |
- |
597±51 |
n.d. |
247±23 |
170±27 |
997±97 |
|
||||||
DMSO |
+ |
38±6 |
n.d. |
13±1 |
7±3 |
13±2 |
1000 |
+ |
26±4 |
n.d. |
9±1 |
7±2 |
10±3 |
3333 |
+ |
16±5 |
n.d. |
12±2 |
1±2 |
15±3 |
5000 |
+ |
14±1SP |
n.d. |
15±8SP |
1±1SP |
12±2SP |
Pos. control |
+ |
306±14 |
n.d. |
116±3 |
148±3 |
286±49 |
SP light precipitate
1 the S9-mix contained 10% S9 fraction
n.d. not determined
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
Pelargonic acid was not genotoxic in bacteria. - Executive summary:
Pelargonic acid was not mutagenic in the Ames test (OECD guideline No. 471) using Salmonella typhimurium (strains TA98, TA100, TA1535, and TA1537) and E. coli (WP2uvrA) when tested up 5000 µg/mL with and without metabolic activation under GLP conditions. Precipitation was seen at 5000 µg/mL. Strain specific cytotoxicity was seen, as evidenced by reduced bacterial background lawn and/or reduction of the number of revertant colonies with increasing doses. Solvent control and positive controls performed as expected. Thus, pelargonic acid was not genotoxic in bacteria (NOTOX, 2001).
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