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Registration Dossier
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EC number: 217-978-1 | CAS number: 2028-63-9
Toxicological information
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October - November 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Year 1991 or earlier
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Version / remarks:
- Year 1991 or earlier
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- But-3-yn-2-ol
- EC Number:
- 217-978-1
- EC Name:
- But-3-yn-2-ol
- Cas Number:
- 2028-63-9
- Molecular formula:
- C4H6O
- IUPAC Name:
- but-3-yn-2-ol
- Details on test material:
- purity 56.1%
other component: water
according to order sheet from Dec 2nd 1988
Constituent 1
Method
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:
- rat liver S-9 mix
- Test concentrations with justification for top dose:
- 20, 100, 500, 2500 and 5000 µg/plate
- Vehicle / solvent:
- water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- 10 µg for all S. typhimurium strains, 60 µg for E.coli with activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- 5 µg for TA 100 and TA 1535 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamine
- Remarks:
- 10 µg for TA 98 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine chloride monohydrate
- Remarks:
- 100 µg for TA 1537 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- 10 µg for E.coli without activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 37 °C for 20 min
- Exposure duration: 48 h at 37 °C
NUMBER OF REPLICATIONS: each 3 plates 2 times
DETERMINATION OF CYTOTOXICITY
- Method: reduction of background growth - Evaluation criteria:
- Substance is positive in bacterial test if:
- causes doubling of spontaneous mutation rate (control)
- has a dose-response relationship
- has reproducible results - Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- 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
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Untreated negative controls validity:
- not examined
- 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
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Complete solubility of the test substance in aqua dest.
No bacteriotoxic effects observed. - Remarks on result:
- other: standard plate test and preincubation test
Any other information on results incl. tables
Standard plate test
| Dose (µg/plate) | Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli | ||||
| TA1535 | TA100 | TA1537 | TA98 | WP2 uvrA | |
| Results without S9 | |||||
| Aqua dest | 14 ± 2 | 92 ± 12 | 8 ± 1 | 22 ± 3 | 26 ± 2 |
| 20 | 15 ± 3 | 91 ± 6 | 6 ± 1 | 21 ± 3 | 23 ± 3 |
| 100 | 12 ± 3 | 93 ± 10 | 8 ± 3 | 22 ± 3 | 22 ± 4 |
| 500 | 13 ± 2 | 102 ± 10 | 10 ± 1 | 18 ± 7 | 23 ± 6 |
| 2500 | 19 ± 2 | 78 ± 12 | 12 ± 3 | 20 ± 7 | 24 ± 7 |
| 5000 | 13 ± 3 | 81 ± 2 | 9 ± 3 | 21 ± 2 | 18 ± 6 |
| MNNG (5) | 1917 ± 100 | 1787 ± 225 | |||
| AAC (100) | 506 ± 98 | ||||
| NPD (10) | 736 ± 71 | ||||
| ENNG (10) | 417 ± 37 | ||||
| Results with S9 | |||||
| Aqua dest | 16 ± 3 | 101 ± 16 | 11 ± 5 | 35 ± 2 | 30 ± 3 |
| 20 | 14 ± 3 | 107 ± 6 | 15 ± 1 | 34 ± 5 | 33 ± 2 |
| 100 | 11 ± 1 | 96 ± 6 | 10 ± 2 | 31 ± 5 | 30 ± 6 |
| 500 | 15 ± 3 | 81 ± 15 | 13 ± 2 | 31 ± 8 | 33 ± 2 |
| 2500 | 15 ± 2 | 86 ± 13 | 15 ± 1 | 33 ± 2 | 31 ± 3 |
| 5000 | 15 ± 1 | 98 ± 13 | 17 ± 3 | 35 ± 3 | 33 ± 6 |
| 2-AA (10) | 183 ± 22 | 1273 ± 206 | 158 ± 14 | no value | |
| 2-AA (60) | 138 ± 15 | ||||
Preincubation test
| Dose (µg/plate) | Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli | ||||
| TA1535 | TA100 | TA1537 | TA98 | WP2 uvrA | |
| Results without S9 | |||||
| Aqua dest | 15 ± 3 | 109 ± 6 | 8 ± 2 | 25 ± 3 | 22 ± 3 |
| 20 | 14 ± 3 | 105 ± 12 | 9 ± 1 | 19 ± 4 | 22 ± 2 |
| 100 | 13 ± 3 | 101 ± 9 | 9 ± 1 | 21 ± 1 | 21v1 |
| 500 | 13 ± | 108 ± 9 | 9 ± 1 | 19 ± 2 | 22 ± 2 |
| 2500 | 18 ± 5 | 101 ± 12 | 8 ± 3 | 22 ± 2 | 21 ± 4 |
| 5000 | 16 ± 5 | 85 ± 2 | 11 ± 4 | 23 ± 1 | 19 ± 2 |
| MNNG (5) | 1029 ± 42 | 1095 ± 107 | |||
| AAC (100) | 459 ± 51 | ||||
| NPD (10) | 979 ± 106 | ||||
| ENNG (10) | 613 ± 22 | ||||
| Results with S9 | |||||
| Aqua dest | 15 ± 4 | 113 ± 8 | 12 ± 2 | 35 ± 6 | 23 ± 3 |
| 20 | 14 ± 3 | 97 ± 6 | 13 ± 3 | 35 ± 2 | 20 ± 1 |
| 100 | 14 ± 2 | 123 ± 5 | 12 ± 4 | 35 ± 6 | 24 ± 1 |
| 500 | 14 ± 4 | 106 ± 13 | 9 ± 2 | 36 ± 6 | 23 ± 4 |
| 2500 | 15 ± 1 | 101 ± 12 | 12 ± 3 | 34 ± 3 | 22 ± 2 |
| 5000 | 14 ± 2 | 105 ± 3 | 11 ± 2 | 31 ± 2 | 23 ± 1 |
| 2-AA (10) | 156 ± 11 | 908 ± 54 | 106 ± 10 | 709 ± 114 | |
| 2-AA (60) | 69 ± 17 | ||||
Applicant's summary and conclusion
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