Registration Dossier
Registration Dossier
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EC number: 700-100-0 | CAS number: 39716-58-0
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:
- other: The study was conducted according to the OECD guideline 471 and is fully GLP-compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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 (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Pent-4-enoic acid
- EC Number:
- 209-732-7
- EC Name:
- Pent-4-enoic acid
- Cas Number:
- 591-80-0
- Molecular formula:
- C5H8O2
- IUPAC Name:
- pent-4-enoic acid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- first assay (plate incorporation): 0, 100, 316, 1000, 3160, 5000 µg/plate
second assay (preincubation): 0, 10, 31.6, 100,316, 1000 µg/plate
In the second assay the concentration was reduced because cytotoxicity was observed. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: for TA98 without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: for TA1537 without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Migrated to IUCLID6: for TA102 without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: 2-amina anthracene for TA98, TA102, TA1537 with metabolic activation
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Migrated to IUCLID6: for TA100 and TA1535 with metabolic activation
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
first assay in agar (plate incorporation)
second assay preincubation
DURATION first assay
- Preincubation period: no
- Exposure duration: 72 hours
DURATION second assay
- Preincubation period: 20 minutes
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- A test item was considered to show a positive response if
- the number of revertants is significantly increased (p >= 0.05, U-test) compared with the solvent control to at least 2-fold of the solvent control for TA98, TA100 and TA 102 and 3-fold of the solvent control for TA1535 and TA1537 in both independent experiments - Statistics:
- U-test according to MANN and WHITNEY
Results and discussion
Test results
- 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:
- cytotoxicity
- Remarks:
- at 1000µg/plate in the preincubation assay
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
in a preliminary test concentrations ranging from 0.316 to 5000 µg/plate were analysed for cytotoxicity. Pronounced cytotoxicity (scarce background lawn and reduction of the number of revertants by more than 50 %) was noted at concentrations from 1000 µg/plate onwards in the preincubation test.
COMPARISON WITH HISTORICAL CONTROL DATA:
The range of the spontaneous reversion frequencies are
TA98: 20 - 60
TA100: 100-200
TA102:240-320
TA1535: 10-35
TA1537: 3-20
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Plate incorporation test; Number of revertants per plate (mean of three plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
38 |
38 |
no |
144.7 |
149 |
no |
286.3 |
281.3 |
no |
100 |
39 |
30.3 |
no |
122.7 |
143.3 |
no |
277.3 |
278.3 |
no |
316 |
24.7 |
36.7 |
no |
135.7 |
145.3 |
no |
269 |
271.0 |
no |
1000 |
28.3 |
33.7 |
no |
143 |
143 |
no |
282.3 |
264.3 |
no |
3160 |
28.7 |
25.7 |
no |
118.3 |
114.3 |
no |
260.7 |
268.7 |
no |
5000 |
15 |
29 |
no |
44 |
132.7 |
no |
183.3 |
259.3 |
no |
Positive control |
603.7 |
586.7 |
no |
824.7 |
813 |
no |
1114.3 |
1140 |
no |
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
21 |
20 |
no |
8 |
8.7 |
no |
100 |
19 |
19 |
no |
5.7 |
6 |
no |
316 |
17 |
18.7 |
no |
5.7 |
7 |
no |
1000 |
18.7 |
18.7 |
no |
7 |
6.3 |
no |
3160 |
15.3 |
17 |
no |
4.7 |
5.7 |
no |
5000 |
11 |
14.7 |
no |
1.3 |
6.3 |
no |
Positive control |
299.7 |
302.3 |
no |
267.3 |
282.3 |
no |
*solvent control with water
Table 2: Preincubation test; Number of revertants per plate (mean of three plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
37.7 |
33.3 |
no |
154.3 |
171 |
no |
284.7 |
274.73 |
no |
10 |
32 |
33 |
no |
130.3 |
148.7 |
no |
282.3 |
273.3 |
no |
31.6 |
31.77 |
23 |
no |
147 |
141.7 |
no |
262 |
261.7 |
no |
100 |
22.7 |
26.3 |
no |
135.3 |
116 |
no |
272 |
274 |
no |
316 |
23.7 |
29.7 |
no |
141.3 |
118.3 |
no |
274.7 |
258 |
no |
1000 |
13.7 |
26.3 |
yes |
43.3 |
58.7 |
yes |
188 |
147 |
yes |
Positive control |
603.7 |
586.7 |
no |
824.7 |
813 |
no |
1114.3 |
1140 |
no |
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
20.3 |
17 |
no |
6.3 |
6 |
no |
10 |
15.7 |
15.3 |
no |
5 |
5 |
no |
31.6 |
16 |
16 |
no |
4 |
4.3 |
no |
100 |
14 |
15.7 |
no |
4 |
4.3 |
no |
316 |
11 |
13.3 |
no |
4 |
3.7 |
no |
1000 |
7.7 |
7.7 |
yes |
2.3 |
1.7 |
yes |
Positive control |
299.7 |
302.3 |
no |
267.3 |
282.3 |
no |
*solvent control with water
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Under the test conditions of the study 4-Pentenoic acid tested up to cytotoxic concentrations caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535, TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
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