Registration Dossier
Registration Dossier
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EC number: 204-624-6 | CAS number: 123-39-7
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is comparable to OECD Guideline 471 with acceptable restrictions (no details about the test substance; no data on pH or osmolality [but negative results]; no data about historical controls [but vehicle control within values published elsewhere]).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- monomethylformamide
- IUPAC Name:
- monomethylformamide
- Reference substance name:
- N-methylformamide
- EC Number:
- 204-624-6
- EC Name:
- N-methylformamide
- Cas Number:
- 123-39-7
- Molecular formula:
- C2H5NO
- IUPAC Name:
- N-methylformamide
- Details on test material:
- clourless liquid
stability of the test substance has been shown by analytical control (reanalysis)
no further data
Constituent 1
Constituent 2
Method
- Target gene:
- His- (S. typhimurium)
Try- (E.coli)
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 100, 98, 1535, 1537, E. coli WP2uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9-fraction prepared from livers of at least 5 male Sprague-Dawley rats i.p. injected with 500 mg/kg bw Aroclor1254 5 days prior to sacrifice.
- Test concentrations with justification for top dose:
- 2 independent experiments with and without metabolic activation
1) standard plate test: 0, 40, 200, 1000, 5000, and 10000 µg/plate
2) preincubation assay: 0, 40, 200, 1000, 5000, and 10000 µg/plate - Vehicle / solvent:
- water
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see below
- Details on test system and experimental conditions:
- S9-mix prepared freshly prior to experiment.
3 plates per dose level.
Positive control with S-9 mix:
2.5 µg/plate 2-aminoanthracene (2-AA) dissolved in DMSO for the strains TA 100, TA 98, TA 1537 and TA 1535
and 60 µg/plate 2-aminoanthracene dissolved in DMSO for the strain E. coli WP2 uvrA
Positive control without S-9 mix:
5 µg/plate N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) dissolved in DMSO for the strains TA 100 and TA 1535
10 µg/plate 4-nitro-o-phenylendiamine (NOPD) dissolved in DMSO for the strain TA 98
100 µg/plate 9-aminoacridine chioride monohydrate (AAC) dissolved in DMSO for the strain TA 1537
10 µg/plate N-ethyl-N'-nitro-N-nitrosoguanidin (ENNG) dissolved in DMSO for the strain E. coli WP2 uvrA - Evaluation criteria:
- - doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results - Statistics:
- Mean +- SD (standard deviation) was calculated.
Results and discussion
Test results
- Species / strain:
- bacteria, other: Salmonella typhimurium TA 100, 98, 1535, 1537, E. coli WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- (10 mg/plate, no precipitates)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No test substance precipitation was found.
No data about historical controls but vehicle controls within values published elsewhere.
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data - Remarks on result:
- other: other: standard plate test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Mutagenicity in the Ames test with and without metabolic activation
Mean number of revertants +- standard deviation
Dose in µg per plate |
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli WP2uvrA |
|||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
- |
Standard plate test |
|||||||||
Water |
32+-2 |
40+-2 |
139+-3 |
157+-3 |
19+-3 |
19+-1 |
10+-2 |
10+-1 |
30+-4 |
39+-2 |
40 |
31+-4 |
38+-8 |
145+-14 |
161+-3 |
18+-1 |
18+-2 |
9+-1 |
10+-3 |
32+-0 |
37+-2 |
200 |
27+-5 |
36+-2 |
147+-7 |
155+-14 |
14+-2 |
18+-1 |
8+-1 |
10+-2 |
31+-1 |
31+-1 |
1000 |
26+-4 |
36+-1 |
143+-11 |
129+-21 |
13+-2 |
20+-2 |
8+-1 |
8+-2 |
33+-6 |
31+-2 |
5000 |
24+-5 |
37+-2 |
170+-9 |
151+-20 |
14+-1 |
13+-2 |
9+-1 |
9+-3 |
27+-5 |
32+-4 |
10000 |
23+-5 |
36+-5 |
159+-9 |
125+-19 |
12+-4 |
16+-2 |
8+-2 |
7+-1 |
25+-3 |
30+-3 |
Positive control |
1004+-5 |
1151+-156 |
1264+-175 |
1227+-113 |
1821+-388 |
175+-43 |
734+-22 |
132+-18 |
501+-10 |
241+-19 |
- |
Preincubation assay |
|||||||||
Water |
32+-3 |
47+-5 |
134+-12 |
149+-11 |
20+-3 |
21+-3 |
10+-3 |
12+-3 |
33+-2 |
43+-4 |
40 |
33+-2 |
41+-1 |
136+-11 |
141+-9 |
21+-4 |
19+-4 |
10+-1 |
11+-2 |
35+-3 |
42+-3 |
200 |
33+-3 |
41+-5 |
140+-16 |
148+-11 |
20+-4 |
19+-2 |
9+-2 |
12+-2 |
31+-2 |
43+-3 |
1000 |
30+-4 |
42+-3 |
121+-19 |
160+-6 |
20+-3 |
17+-1 |
11+-2 |
11+-1 |
31+-3 |
42+-5 |
5000 |
34+-4 |
39+-3 |
138+-11 |
156+-6 |
20+-3 |
16+-3 |
9+-1 |
11+-2 |
32+-4 |
45+-6 |
10000 |
32+-4 |
43+-2 |
126+-3 |
143+-4 |
20+-4 |
15+-3 |
7+-2 |
11+-3 |
33+-3 |
36+-3 |
Positive control |
1144+-73 |
975+-39 |
1194+-51 |
866+-24 |
1027+-26 |
111+-16 |
833+-73 |
121+-3 |
507+-17 |
210+-12 |
MA: metabolic activation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
No mutagenic and cytotoxic activity was detected with and without metabolic activation even at concentrations of 10 mg/plate in the Ames test using S. typhimurium TA98, 100, 1535, 1537 and E. coli WP2uvrA. - Executive summary:
The study is comparable to OECD Guideline 471 with acceptable restrictions (no details about the test substance solution; no data on pH or osmolality [but negative results]; no data about historical controls [but vehicle control within values published elsewhere]).
In the Ames test with S.typhimurium TA98, 100, 1535, 1537 and E. coli WP2uvrA the test substance was studied using two different protocols with and without addition of a metabolic activation system: the standard plate test and the preincubation test (dose levels: 0; 40; 200; 1000; 5000 and 10000 µg/plate). Negative and positive controls were valid. In each test system cytotoxic concentrations were not reached but dose levels were >= 5 mg/plate. There was no increase in revertants in any strain.
Conclusion: No mutagenic and cytotoxic activity was detected with and without metabolic activation even at concentrations of 10 mg/plate in the Ames test using S. typhimurium TA98, 100, 1535, 1537 and E. coli WP2uvrA.
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