Registration Dossier
Registration Dossier
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EC number: 939-235-7 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comprehensive test programme using test procedures in accordance with accepted standard methods, sufficiently documented.
Data source
Reference
- Reference Type:
- publication
- Title:
- The results of microbial mutation test for forty-three industrial chemicals.
- Author:
- Shimizu, H. et al.
- Year:
- 1 985
- Bibliographic source:
- Jpn J Ind Health 27: 400-419
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methanol
- EC Number:
- 200-659-6
- EC Name:
- Methanol
- Cas Number:
- 67-56-1
- Molecular formula:
- CH4O
- IUPAC Name:
- methanol
- Details on test material:
- - Name of test material (as cited in study report): Methanol
- Analytical purity: 99.6 % pure, no further data
- Other: Source: Wako Pure Chemical Industries, LTD., Osaka, Japan
Constituent 1
Method
- Target gene:
- His-operon, Trp-operon (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 fraction of KC500-pretreated rats
- Test concentrations with justification for top dose:
- 5, 10, 50, 100, 500, 1000, 5000 µg/plate
- 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
- Remarks:
- 0.01 and 5.0 µg/plate, respectively
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2) without S9, benzo(a)pyrene (B(a)P) with S9
- Remarks:
- TA100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- both 5.0 µg/plate, respectively
- Positive control substance:
- other: N-ethyl -N'-nitro-N-nitrosoguanidine (ENNG) without S9, 2-aminoanthracene (2AA) with S9
- Remarks:
- TA1535both 5.0 µg/plate, respectively
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.05 and 5.0 µg/plate, respectively
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2) without S9, 2-aminoanthracene (2AA) with S9
- Remarks:
- WP2 uvrA
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.05 and 5.0 µg/plate, respectively
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2) without S9, benzo(a)pyrene (B(a)P) with S9
- Remarks:
- TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 80.0 and 5.0 µg/plate, respectively
- Positive control substance:
- other: 9-aminoacridine (9AC) without S9, benzo(a)pyrene (B(a)P) with S9
- Remarks:
- TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.25 and 5.0 µg/plate, respectively
- Positive control substance:
- other: 4-nitroquinoline-1-oxide (4NQO) without S9, benzo(a)pyrene (B(a)P) with S9
- Remarks:
- TA1538
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: duplicates
DETERMINATION OF CYTOTOXICITY
- Method: other: growth inhibition of revertant clones - Evaluation criteria:
- Doubling of revertant numbers in comparison to control and dose-response correlation.
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:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
Any other information on results incl. tables
Maximum number of revertants:
|
Control (water) [mean±SD] |
Test substance (µg/plate) |
||
Strain |
-S9 |
+S9 |
-S9 |
+S9 |
TA100 |
149±17.1 |
161±16.2 |
175 (100) |
180 (50) |
TA1535 |
28±6.9 |
15±3.6 |
35 (50) |
17 (5000) |
TA98 |
29±6.2 |
39±8.6 |
42 (50) |
39 (1000) |
TA1537 |
16±6.4 |
21±8.1 |
22 (5000) |
35 (5) |
TA1538 |
21±5.5 |
28±7.0 |
18 (500) |
31 (5) |
E.coli WP2 uvrA |
32±7.3 |
33±10.3 |
36 (5000) |
43 (10) |
The test substance was not mutagenic in the tested strains up to 5000 µg/plate.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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