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EC number: 212-079-0 | CAS number: 760-23-6
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:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study. Adopted according to OECD SIDS (public available peer reviewed source). The original source is available and has been reviewed.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report for 11th SIAM
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3,4-dichlorobut-1-ene
- EC Number:
- 212-079-0
- EC Name:
- 3,4-dichlorobut-1-ene
- Cas Number:
- 760-23-6
- Molecular formula:
- C4H6Cl2
- IUPAC Name:
- 3,4-dichlorobut-1-ene
- Details on test material:
- - Name of test material (as cited in study report): 3,4-dichlorobut-1-ene
- Analytical purity: 99%
Constituent 1
Method
- Target gene:
- his operon, trp operon
Species / strain
- Species / strain / cell type:
- other: S.typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver, induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- -S9 mix: 0, 250 -2500 µg/plate (TA100 and TA1535); 0, 39 - 2500 µg/plate (WP2); 0, 78 - 2500 µg/plate (TA98); 39 - 2500 µg/plate (TA1537)
+S9 mix: 0, 1000 - 3000 (TA100); 0, 500 - 2500 µg/plate (TA1535); 0, 39 - 2500 µg/late (TA1537 and WP2); 0, 39 - 5000 µg/plate (TA98). - Vehicle / solvent:
- acetone
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (five strains,+S9 mix)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: TA1535; -S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (TA100, WP2, TA98; -S9 mix)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: TA1537; -S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Plate incubation method
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
Results and discussion
Test results
- Species / strain:
- other: S.typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- Salm. typh. TA 1535
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- This chemical induced gene mutations in the S. typhimurium TA 1535. Toxicity was observed at 625 µg/plate (TA98 and TA1537), 850 µg/plate (TA100), 1000 µg/plate (TA1535) and 1250 µg/plate (WP2) with the -S9 mix, and at 1250 µg/plate (WP2, TA98 and TA1537), 1500 µg/plate (TA1535) and 2200 µg/plate (TA100) with the +S9 mix.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table1. Results of confirmation test (I) in reverse mutation test of 3,4 -dichloro-1 -butene on bacteria
| With (-) or Without (+) S9 mix | Test substance dose (µg/plate) | Number of revertants (number of colonies/plate, mean±SD) | |
| S9 mix - | Base-pair substitution type | ||
| - | TA100 | TA1535 | |
| - | 0 | 148±7.0 | 16±3.6 |
| - | 250 | 186±26.2 | 20±4.9 |
| - | 400 | 222±37.3 | 33±3.1 |
| - | 550 | 264±29.9 | 30±4.0 |
| - | 700 | 282±11.9 | 35±5.5 |
| - | 850 | 271±6.7 | 48±3.5 |
| - | 1000 | 288±62.1* | 45±8.1* |
| Positive control S9 mix (-) | Chemical | AF2 | SA |
| Dose (µg/plate) | 0.01 | 0.5 | |
| Number of colonies / plate | 729±33.4 | 178±7.0 | |
AF2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide, SA: Sodium azide
*: Inhibition was observed against growth of the bacteria.
Table 2. Results of confirmation test (I) in reverse mutation test of 3,4 -dichloro-1 -butene on bacteria
| With (-) or Without (+) S9 mix | Test substance dose (µg/plate) | Number of revertants (number of colonies/plate, mean±SD) | ||
| Base-pair substitution type | Frameshift type | |||
| S9 mix - | WP2uvrA | TA98 | TA1537 | |
| - | 0 | 22±4.6 | 23±4.0 | |
| - | 39 | 24±4.0 | ND | |
| - | 78 | 27±7.1 | 25±1.5 | |
| - | 156 | 27±5.1 | 29±6.1 | |
| - | 313 | 31 ± 1.5 | 22±2.3 | |
| - | 625 | 28±6.1 | 25±2.1 | |
| - | 1250 | 28±5.5* | 24±4.5* | |
| - | 2500 | 0±0.0* | ||
| S9 mix + | 0 | 18±4.6 | 31±5.0 | 10±1.2 |
| + | 39 | 24±0.6 | 30±3.1 | 9±2.3 |
| + | 78 | 25±2.1 | 27± 10.4 | 12±3.6 |
| + | 156 | 23±10.1 | 27±3.5 | 11±4.0 |
| + | 313 | 26±5.3 | 24±10.4 | 9±2.3 |
| + | 625 | 17±6.8 | 30±10.4 | 9±2.0 |
| + | 1250 | 25±3.6* | 19±5.5* | 6±1.2* |
| Positive control S9 mix - | Chemical | AF2 | AF2 | |
| Dose (µg/plate) | 0.01 | 0.1 | ||
| Number of colonies / plate | 161±10.8 | 893±24.0 | ||
| Positive control S9 mix + | Chemical | 2AA | 2AA | 2AA |
| Dose (µg/plate) | 10 | 0.5 | 2 | |
| Number of colonies / plate | 1357±21.4 | 381±33.5 | 261±22.0 | |
AF2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide, 2AA: 2 -Aminoantthracene
*: Inhibition was observed against growth of the bacteria.
Table 3. Results of confirmation test (I) in reverse mutation test of 3,4 -dichloro-1 -butene on bacteria
| With (-) or Without (+) S9 mix | Test substance dose (µg/plate) | Number of revertants (number of colonies/plate, mean±SD) |
| S9 mix (-) | 0 | 113±15.0 |
| - | 250 | 190±14.4 |
| - | 400 | 206±31.0 |
| - | 550 | 196±19.3 |
| - | 700 | 214±8.3 |
| - | 850 | 203±8.3 |
| - | 1000 | 219±11.6 |
| Positive control S9 mix (-) | Chemical | AF2 |
| Dose (µg/plate) | 0.01 | |
| Number of colonies/plate | 654±28.2 | |
AF2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide, 2AA: 2 -Aminoantthracene
*: Inhibition was observed against growth of the bacteria.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive TA1535 at 1000µg/plate - Executive summary:
MHW, Japan (1996)
3,4-DCB has been tested for bacterial reverse mutation in Salmonella typhimurium and Escherichia coli with and without an exogenous metabolic activation by OECD TG 471 test; at the following dosage: -S9 mix, 0, 250 -2500 µg/plate (TA100 and TA1535), 0, 39 - 2500 µg/plate (WP2), 0, 78 - 2500 µg/plate (TA98) and 39 - 2500 µg/plate (TA1537). This chemical shows mutagenicity only in TA1535 at 1000 µg/plate, but not in other Salmonella typhimurium strains or Escherichia coli strain. In the case of TA1535, the number of induced colonies/plate, indicates that this chemical is weakly mutagenic.
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