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EC number: 436-690-9 | CAS number: 220727-26-4
- 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:
- 24 Apr - 17 May 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Hessisches Ministerium für Umwelt, Energie, Jugend, Familie und Gesundheit, 1998
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): Y-15099
- Physical state: pale yellow liquid
- Analytical purity: 97.8%
- Lot/batch No.: 18244-30
- Expiration date of the lot/batch: 2002-10-23
- Stability under test conditions: stable in ethanol
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- his operon (S. typhimurium)
trp operon (WP2 uvrA)
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and WP2 uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 0, 33, 100, 333, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- Ethanol
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- sodium azide (+S9: 10 µg/plate in TA 1535, TA 100), 4-nitro-o-phenylene-diamine (+S9: 10 µg/plate in TA 98, 50 µg/plate in TA 1537), methylmethanesulfonate (+S9: 5 µL/plate in WP2 uvrA), 2-aminoanthracene (-S9: 2.5 µg/plate and 10 µg/
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) (Experiment 1) and pre-incubation test (Experiment 2)
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: triplicates in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: background growth and reduction in the number of revertants - Evaluation criteria:
- A test item is considered positive if either a dose related increase in the number of revertants or a biologically relevant increase for at least one test concentration is induced.
A test item producing neither a dose related increase in the number of revertants, nor a biologically relevant positive response at any one of the test points is considered non-mutagenic in this system.
A mutagenic response is described as follows:
A test item is considered mutagenic if in the strains Ta 98, TA 100, and WP2 uvrA the number of reversions will be at least twice as high and in the strains TA 1535 and TA 1537 at least three times higher as compared to the spontaneous reversion rate.
Also, a dose-dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test regardless whether the highest dose induced the above described enhancement factors or not. - Statistics:
- No data.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100 and 1000 - 5000 µg/plate in TA 100 -S9; 1000 - 5000 µg/plate in TA 1535, TA 1537, TA 98, and TA 100 with S9; 2500 - 5000 µg/plate in WP2 uvrA with S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in both experiments.
Toxic effects, evident as a reduction in number of revertants, were observed in all strains at concentrations of 1000 µg/plate or above. Additionally toxic effects were seen in strain TA 100 at 100 µg/plate without S9 mix.
Any other information on results incl. tables
Table 1: Ames Test Results - Experiment 1 (Plate incorporation Test)
With or without S9-Mix |
Test substance concentration (µg/plate) |
Mean number of revertant colonies per plate (average of triplicate) |
||||
Base-pair substitution type |
Frameshift type |
Base-pair substitution and other |
||||
TA 1535 |
TA1537 |
TA 100 |
TA98 |
WP2 uvrA |
||
- |
Negative control |
11 |
9 |
164 |
31 |
52 |
- |
Vehicle control |
14 |
10 |
136 |
30 |
51 |
- |
33 |
11 |
11 |
161 |
35 |
52 |
- |
100 |
14 |
13 |
153 |
35 |
58 |
- |
333 |
17 |
12 |
156 |
40 |
53 |
- |
1000 |
18 |
11 |
159 |
35 |
62 |
- |
2500 |
15 |
12 |
144 |
40 |
58 |
- |
5000 |
14 |
16 |
144 |
36 |
58 |
Positive controls - S9 |
Name |
SA |
4NP |
SA |
4NP |
MMS |
Concentrations (µg/plate) |
10 |
50 |
10 |
10 |
5 µl |
|
Number of colonies/plate |
1549 |
58 |
625 |
159 |
856 |
|
|
TA 1535 |
TA 1537 |
TA 100 |
TA98 |
WP2 uvrA |
|
+ |
Negative control |
17 |
20 |
185 |
40 |
50 |
+ |
Vehicle control |
16 |
14 |
184 |
49 |
52 |
+ |
33 |
21 |
22 |
173 |
40 |
56 |
+ |
100 |
23 |
20 |
145 |
41 |
63 |
+ |
333 |
18 |
17 |
151 |
45 |
60 |
+ |
1000 |
22 |
22 |
135 |
44 |
52 |
+ |
2500 |
18 |
26 |
148 |
40 |
60 |
+ |
5000 |
11 |
13 |
114 |
27 |
40 |
Positive controls + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (µg/plate) |
2.5 |
2.5 |
2.5 |
2.5 |
10 |
|
Number of colonies/plate |
263 |
130 |
912 |
477 |
226 |
Table 2: Ames Test Results - Experiment 2 (Pre-Incubation Test)
With or without S9-Mix |
Test substance concentration (µg/plate) |
Mean number of revertant colonies per plate (average of triplicate) |
||||
Base-pair substitution type |
Frameshift type |
Base-pair substitution and other |
||||
TA 1535 |
TA1537 |
TA 100 |
TA98 |
WP2 uvrA |
||
- |
Negative control |
14 |
6 |
147 |
21 |
42 |
- |
Vehicle control |
9 |
8 |
133 |
27 |
41 |
- |
33 |
14 |
8 |
88 |
31 |
42 |
- |
100 |
10 |
6 |
69 |
23 |
45 |
- |
333 |
8 |
7 |
87 |
20 |
47 |
- |
1000 |
8 |
4 |
63 |
25 |
45 |
- |
2500 |
7 |
5 |
67 |
31 |
37 |
- |
5000 |
7 |
6 |
72 |
28 |
67 |
Positive controls - S9 |
Name |
SA |
4NP |
SA |
4NP |
MMS |
Concentrations (µg/plate) |
10 |
50 |
10 |
10 |
5 µl |
|
Number of colonies/plate |
618 |
53 |
759 |
189 |
414 |
|
|
TA 1535 |
TA 1537 |
TA 100 |
TA98 |
WP2 uvrA |
|
+ |
Negative control |
20 |
12 |
168 |
28 |
51 |
+ |
Vehicle control |
23 |
9 |
150 |
36 |
48 |
+ |
33 |
14 |
12 |
131 |
35 |
71 |
+ |
100 |
14 |
5 |
143 |
33 |
68 |
+ |
333 |
16 |
6 |
90 |
26 |
64 |
+ |
1000 |
5 |
3 |
59 |
10 |
30 |
+ |
2500 |
8 |
1 |
4 |
6 |
19 |
+ |
5000 |
6 |
0 |
0 |
0 |
19 |
Positive controls + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (µg/plate) |
2.5 |
2.5 |
2.5 |
2.5 |
10 |
|
Number of colonies/plate |
151 |
63 |
681 |
387 |
218 |
SA = Sodium azide
4NP = 4-Nitro-o-phenylene-diamine
MMS = Methyl methane sulfonate
2AA = 2-Aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- During the mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
- Executive summary:
This study was performed to investigate the potential of Y-15099 to induce gene mutations according to the OECD guideline 471 in a plate incorporation test (Experiment 1) and a pre-incubation test (Experiment 2) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in 2 independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations: 0, 33, 100, 333, 1000, 2500, and 5000 µg/plate.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation. Toxic effects, evident as a reduction in number of revertants, were observed in all strains at concentrations of 1000 µg/plate or above. Additionally toxic effects were seen in strain TA 100 at 100 µg/plate without S9 mix.
No substantial increase in revertant colony numbers of any of the 5 tester strains was observed following treatment with Y-15099 at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
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