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EC number: 470-180-7 | CAS number: 61196-40-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2004-12-21 to 2005-05-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 470-180-7
- EC Name:
- -
- Cas Number:
- 61196-40-5
- Molecular formula:
- C14H16N2O2
- IUPAC Name:
- 2-acetyl-1H,2H,3H,4H,6H,7H,11bH-pyrazino[2,1-a]isoquinolin-4-one
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S-9 mix.
- Test concentrations with justification for top dose:
- Concentration range in the 1st main test (with and without metabolic activation): 5.00, 15.8, 50.0, 158, 500, 1580 and 5000 µg/plate
Concentration range in the 2nd main test (with and without metabolic activation): 50.0, 158, 500, 1580 and 5000 µg/plate - Vehicle / solvent:
- Solvent: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- benzo(a)pyrene
- cumene hydroperoxide
- other: Daunomycin and N-ethyl-N'-nitro-N-nitrosoguanidine in the absence of S9 mix. 2-Aminoanthracene with S9 mix.
- Rationale for test conditions:
- According to the guideline
- Evaluation criteria:
- A test material is defined as non-mutagenic in this assay if:
- "no" or "weak increases" occur in the first and second series of the main experiment. ("Weak increases" randomly occur due to experimental variation.)
A test material is defined as mutagenic in this assay if:
- a dose-related (over at least two test material concentrations) increase in the number of revertants is induced, the maximal effect is a "clear increase", and the effects are reproduced at similar concentration levels in the same test system;
- "clear increases" occur at least at one test material concentration, higher concentrations show strong precipitation or cytotoxicity, and the effects are reproduced at the same concentration level in the same test system.
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
- True 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
- True 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
- True 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
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True 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
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1 Summary of mean revertant numbers, run 1
Test Material |
Concentration [µg/plate] |
+/- S9 Mix |
Mean revertant colonies / |
||
|
TA 98 |
TA 100 |
TA 102 |
||
Solvent control |
0 |
- |
17 |
139 |
237 |
Test item |
5 |
- |
20 |
127 |
237 |
15.8 |
- |
23 |
127 |
221 |
|
50 |
- |
19 |
130 |
211 |
|
158 |
- |
20 |
133 |
266 |
|
500 |
- |
25 |
124 |
220 |
|
1580 |
- |
21 |
136 |
197 |
|
5000 |
- |
18 |
110 |
150 |
|
Solvent control |
0 |
+ |
32 |
162 |
310 |
Test item |
5 |
+ |
28 |
157 |
305 |
15.8 |
+ |
32 |
159 |
307 |
|
50 |
+ |
23 |
145 |
313 |
|
158 |
+ |
28 |
149 |
318 |
|
500 |
+ |
31 |
162 |
281 |
|
1580 |
+ |
31 |
153 |
146 |
|
5000 |
+ |
23 |
140 |
211 |
|
Positive controls |
Name |
- |
DAUN |
ENNG |
CUM |
Conc [µg/plate] |
4 |
5 |
200 |
||
Revert. Colonies/plate |
271 |
548 |
1126 |
||
Name |
+ |
2-AA |
2-AA |
B(a)P |
|
Conc [µg/plate] |
2 |
2 |
10 |
||
Revert. Colonies/plate |
401 |
614 |
1659 |
Test Material |
Concentration [µg/plate] |
+/- S9 Mix |
Mean revertant colonies / |
||
|
1535 |
1537 |
E. coli WP2 uvrA |
||
Solvent control |
0 |
- |
18 |
6 |
43 |
Test item |
5 |
- |
24 |
3 |
41 |
15.8 |
- |
27 |
6 |
46 |
|
50 |
- |
27 |
5 |
44 |
|
158 |
- |
20 |
3 |
44 |
|
500 |
- |
17 |
4 |
46 |
|
1580 |
- |
24 |
7 |
43 |
|
5000 |
- |
19 |
11 |
23 |
|
Solvent control |
0 |
+ |
24 |
8 |
47 |
Test item |
5 |
+ |
25 |
7 |
55 |
15.8 |
+ |
25 |
8 |
53 |
|
50 |
+ |
23 |
8 |
44 |
|
158 |
+ |
22 |
6 |
46 |
|
500 |
+ |
21 |
6 |
49 |
|
1580 |
+ |
23 |
7 |
43 |
|
5000 |
+ |
16 |
2 |
28 |
|
Positive controls |
Name |
- |
ENNG |
9-AA |
ENNG |
Conc [µg/plate] |
10 |
50 |
5 |
||
Revert. Colonies/plate |
312 |
347 |
1027 |
||
Name |
+ |
2-AA |
2-AA |
2-AA |
|
Conc [µg/plate] |
2 |
5 |
10 |
||
Revert. Colonies/plate |
215 |
265 |
407 |
Table 2 Summary of mean revertant numbers, run 2
Test Material |
Concentration [µg/plate] |
+/- S9 Mix |
Mean revertant colonies / |
||
|
TA 98 |
TA 100 |
TA 102 |
||
Solvent control |
0 |
- |
17 |
132 |
211 |
Test item |
50 |
- |
20 |
130 |
222 |
158 |
- |
16 |
123 |
241 |
|
500 |
- |
16 |
125 |
221 |
|
1580 |
- |
16 |
126 |
187 |
|
5000 |
- |
11 |
105 |
154 |
|
Solvent control |
0 |
+ |
27 |
189 |
207 |
Test item |
50 |
+ |
27 |
184 |
194 |
158 |
+ |
31 |
197 |
193 |
|
500 |
+ |
23 |
191 |
189 |
|
1580 |
+ |
21 |
182 |
184 |
|
5000 |
+ |
21 |
161 |
170 |
|
Positive controls |
Name |
- |
DAUN |
ENNG |
CUM |
Conc [µg/plate] |
4 |
5 |
200 |
||
Revert. Colonies/plate |
522 |
597 |
1077 |
||
Name |
+ |
2-AA |
2-AA |
B(a)P |
|
Conc [µg/plate] |
2 |
2 |
10 |
||
Revert. Colonies/plate |
113 |
180 |
568 |
Test Material |
Concentration [µg/plate] |
+/- S9 Mix |
Mean revertant colonies / |
||
|
1535 |
1537 |
E. coli WP2 uvrA |
||
Solvent control |
0 |
- |
19 |
7 |
47 |
Test item |
50 |
- |
20 |
5 |
38 |
158 |
- |
16 |
8 |
44 |
|
500 |
- |
18 |
9 |
37 |
|
1580 |
- |
21 |
6 |
37 |
|
5000 |
- |
15 |
12 |
31 |
|
Solvent control |
0 |
+ |
23 |
10 |
50 |
Test item |
50 |
+ |
23 |
11 |
53 |
158 |
+ |
28 |
12 |
49 |
|
500 |
+ |
23 |
9 |
41 |
|
1580 |
+ |
23 |
7 |
42 |
|
5000 |
+ |
16 |
7 |
32 |
|
Positive controls |
Name |
- |
ENNG |
9-AA |
ENNG |
Conc [µg/plate] |
10 |
50 |
5 |
||
Revert. Colonies/plate |
436 |
391 |
910 |
||
Name |
+ |
2-AA |
2-AA |
2-AA |
|
Conc [µg/plate] |
2 |
10 |
10 |
||
Revert. Colonies/plate |
120 |
209 |
152 |
DAUN: Daunomycin
ENNG: N-Ethyl-N'-nitro-N-nitroso-guanidine
CUM: Cumene hydroperoxide
2-AA: 2-Aminoanthracene
B(a)p: Benzo(a)pyrene
9-AA: 9-Aminoacridine
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this assay the test item was not mutagenic to bacterial cells.
- Executive summary:
The investigations for the mutagenic potential of the test material were performed using Salmonella typhimurium tester strains TA 98, TA 100, TA 102, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA according to OECD TG 471. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated rats was used. Two independent experimental series were performed. In the two series with S9 mix, 10 or 30 % S9 in the S9 mix were used in the 1st and 2nd series, respectively. The test item was dissolved in dimethyl sulfoxide (DMSO) and tested at concentrations ranging from 5.00 to 5000 µg/plate. Precipitation of the test material on the agar plates did not occur. Toxicity to the bacteria was not observed. Daunomycin, N-ethyl-N'-nitro-N-nitrosoguanidine, 9-aminoacridine and cumene hydroperoxide served as strain specific positive control test materials in the absence of S9 mix. 2-Aminoanthracene and benzo[a]pyrene were used for testing the bacteria and the activity of the S9 mix. Each treatment with the test materials used as positive controls led to a clear increase in revertant colonies, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used. With and without addition of S9 mix as the external metabolizing system, the test material was not mutagenic under the experimental conditions described.
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