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EC number: 701-317-3 | CAS number: 139734-65-9
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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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: Guideline study, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material: DOPA-Glycinate
Method
- Target gene:
- his (Salmonella strains), trp (E. coli strain)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: Amino-acid requiring strains, histidine for S. typhimurium and tryptophane for E. coli
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- First assay: 0, 62, 185, 556, 1667 and 5000 µg/plate (in the presence and in the absence of rat liver S9 fraction)
Second assay: 0, 12.5, 25, 50, 100 and 200 µg/plate (in the presence and in the absence of rat liver S9 fraction) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Milli-Q-water
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Solvent (Milli-Q-water)
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- ethylnitrosurea
- other: (Absence of S9-mix)
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-aminoanthracene; (Presence of S9-mix)
- Details on test system and experimental conditions:
- Way of application:
Test substance was dissolved in Milli-Q-water at 50 mg/mL. The stock solution was sterilized by passage through a micropore filter (0.45 µM).
For the plate incorporation tests, 0.1 mL of a fully grown culture of the appropriate strain, 0.1 mL of the appropriate test substance solution and 0.5 mL S9-mix for the tests with metabolic activation or 0.5 mL sodium phosphate for the tests without metabolic activation were added to top agar mix and poured onto minimal glucose agar plates. All determinations were made in triplicate. The cultures were incubated at 37°C for 48–72 hours.
Pre-incubation time:
None
Other modifications:
None
Examinations:
Number of revertant colonies
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Genotoxicity
Without metabolic activation: test item dissolved in Milli-Q-water did not cause a two-fold or more increase in the mean number of revertant colonies in all tested strains compared to the background spontaneous reversion rate in the negative control.
The mean number of revertant colonies in the negative controls was within the range of the historical controls.
Positive controls significantly increased the reverse mutation rate.
The results are presented in Table A6.6.1- 1and Table A6.6.1- 2.
With metabolic activation: test item dissolved in Milli-Q-water did not cause a two-fold or more increase in the mean number of revertant colonies in all tested strains compared to the background spontaneous reversion rate in the negative control.
The mean number of revertant colonies in the negative controls was within the range of the historical controls
Positive controls significantly increased the reverse mutation rate.
The results are presented in Table A6.6.1- 1 and Table A6.6.1- 2.
Cytotoxicity
Yes
In the first assay cytotoxicity was observed at and above 185 µg/plate with and without metabolic activation in all tested strains.
In the second assay, cytotoxicity was observed at 200 µg in the absence and presence of S9-mix, except for TA 1535 and TA 100 where normal growth was observed with S9 mix. At 100 µg per plate pin points were observed in TA 1537 and TA 98, in the absence of S9-mix.
The results are presented in Table A6.6.1- 1 and Table A6.6.1- 2. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table A6.6.1 -1:First assay: average numbers of revertants per plate in E.coli or S.typhimurium after treatment with the test item (plate-incorporation assay, triplicate plates per concentration).
Concentration [µg/plate] | TA 1535 | TA 1537 | TA 98 | TA 100 | E.coli | Comments | |||||
–S9 | +S9 | –S9 | +S9 | –S9 | +S9 | –S9 | +S9 | –S9 | +S9 | ||
Control (mean number of revertant colonies) | 26±3 | 28±5 | 23±1 | 17±7 | 47±6 | 69±4 | 191±15 | 167±12 | 33±6 | 37±6 |
|
62 | 27±3 | 21±6 | 16±8 | 23±8 | 27±4 | 67±15 | 162±19 | 173±21 | 34±3 | 40±6 |
|
185 | – | 17±2 | – | 8±5 | – | 11±1 | – | 107±4 | 30±6 | 37±6 | Cytotoxicity |
556 | – | – | – | – | – | – | – | – | – | – | Cytotoxicity |
1667 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | Cytotoxicity |
5000 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | Cytotoxicity |
Positive controls | 606±42 | 814±114 | 4087±1344 | 288±10 | 2219±82 | 1953±83 | 775±58 | 2879±186 | 222±10 | 1527±167 |
|
– plate not counted due to contamination or pin points |
Table A6.6.1-2:Second assay:average numbers of revertants per plate in E.coli or S.typhimurium after treatment with the test item (plate-incorporation assay, triplicate plates per concentration).
Concentration [µg/plate] | TA 1535 | TA 1537 | TA 98 | TA 100 | E.coli | Comments | |||||
–S9 | +S9 | –S9 | +S9 | –S9 | +S9 | –S9 | +S9 | –S9 | +S9 | ||
Control (mean number of revertant colonies) | 24 | 29 | 18 | 26 | 42 | 68 | 184 | 173 ±17 | 47 | 48 |
|
12.5 | 30 | 23 | 19 | 27 | 41 | 69 | 168 | 162 | 49 | 64 |
|
25 | 24 | 18 | 16 | 21 | 32 | 52 | 172 | 144 | 37 | 44 |
|
50 | 25 | 18 | 18 | 29 | 41 | 55 | 187 | 179 | 40 | 44 |
|
100 | 25 | 23 | – | 30 | - | 51 | 164 | 179 | 51 | 47 | Cytotoxicity (pin points observed in TA 1537; TA 98 without S9 mix) |
200 | – | 121 | – | – | – | – | – | 159 | – | – | Cytotoxicity, (except TA 1535 and TA 100 with S9 mix) |
Positive controls | 721 | 500 | 2396 | 316 | 1314 | 845 | 856 | 2205 | 174 | 1695 |
|
– plate not counted due to pin points |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
DOPA-Glycinate was not mutagenic in this bacterial reverse mutation assay in the absence and presence of metabolic activation (S9 mix). - Executive summary:
The mutagenic potential of DOPA-Glycinate (99.4% a.i.) was tested in the bacterial reverse mutation test using the plate incorporation assay. The study was conducted according to OECD guideline 471 (1997).
Two independent plate incorporation assays were performed at concentrations of up to 5000 µg per plate (first assay) or up to 200 µg/plate (second assay). In the first assay cytotoxicity was observed at ≥ 185 µg/plate ± S9 mix in all tested strains. In the second assay, cytotoxicity was observed at 200 µg ± S9 mix in all strains except for TA 1535 and TA 100.
No increase in the number of revertant colonies was found in any of the tested strains with or without metabolic activation while the positive controls gave the expected increase in the mean number of revertant colonies.
Under the conditions of this study, the test item dissolved in water was not mutagenic.
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