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EC number: - | CAS number: -
- 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
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- 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:
- 17 August 2020 - 7 September 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 26 June 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins
- Molecular formula:
- Cannot be adequately determined for this UVCB substance
- IUPAC Name:
- Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins
- Test material form:
- liquid
- Details on test material:
- Physical Description: Brown liquid
Storage Conditions: At room temperature
Constituent 1
- Specific details on test material used for the study:
- Physical Description: Brown liquid
Storage Conditions: At room temperature
Method
- Target gene:
- Histidine locus and tryptophan locus
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Remarks:
- Histidine mutations: TA1537 hisC3076; TA98 hisD3052/R-factor; TA1535 hisG46; TA100 hisG46/R-factor
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: Trinova Biochem GmbH, Giessen, Germany
- method of preparation of S9 mix: rat liver microsomal enzymes (S9 homogenate) prepared from male Sprague Dawley rats that had been injected intraperitoneally with Aroclor 1254 (500 mg/kg body weight). S9-mix was prepared immediately before use and kept refrigerated. S9-mix contained per 10 mL: 30 mg NADP and 15.2 mg glucose-6-phosphate in 5.5 mL or 5.0 mL Milli-Q
water (first or second experiment respectively); 2 mL 0.5 M sodium phosphate buffer pH 7.4; 1 mL 0.08 M MgCl2 solution; 1 mL 0.33 M KCl solution. The above solution was filter (0.22 μm)-sterilized.
- concentration of S9 mix: 5% (v/v) S9-fraction (first experiment); 10% (v/v) S9-fraction (second experiment) - Test concentrations with justification for top dose:
- Dose-range finding test: 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate
First mutation experiment: 17, 52, 164, 512, 1600 and 5000 μg/plate
Second mutation experiment: 10, 50, 100, 500, 1000, and 5000 μg/plate - Vehicle / solvent:
- - Vehicle used: DMSO
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With S9-mix
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: ICR-191
- Remarks:
- Without metabolic activation
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicates
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 ± 4 h at 37.0 ± 1.0 °C
- Harvest time after the end of treatment: Not reported
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined. - Evaluation criteria:
- No formal hypothesis testing was done.
In addition to the criteria stated below, any increase in the total number of revertants should be evaluated for its biological relevance including a comparison of the results with the historical control data range.
A test item is considered negative (not mutagenic) in the test if:
a) The total number of revertants in the tester strain TA100 or WP2uvrA is not greater than two times the concurrent vehicle control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three times the concurrent vehicle control.
b) The negative response should be reproducible in at least one follow-up experiment.
A test item is considered positive (mutagenic) in the test if:
a) The total number of revertants in the tester strain TA100 or WP2uvrA is greater than two times the concurrent vehicle control, or the total number of revertants in tester strains TA1535, TA1537, TA98 is greater than three times the concurrent vehicle control.
b) In case a follow up experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one follow-up experiment.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- Second mutation experiment
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Absence of S9-mix
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Second mutation experiment
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Presence of S9-mix
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Second mutation experiment
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Absence of S9-mix
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Second mutation experiment
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Absence of S9-mix
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Second mutation experiment
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Absence of S9-mix
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- First mutation experiment
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Presence of S9-mix
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- First mutation experiment
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Presence of S9-mix
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- First mutation experiment
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- With and without S9-mix
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- First mutation experiment
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- With and without S9-mix
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- First experiment
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- With and without S9-mix
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Dose-range Finding test/First Mutation Experiment
- Precipitation of the test item on the plates was observed in tester strains TA1535, TA1537 and TA98 in the absence of S9-mix.
- Cytotoxicity, as evidenced by a decrease in the number of revertants and/or the presence of microcolonies, was observed in all tester strains in the absence and presence of S9-mix, except in tester strains WP2uvrA and TA1537 (presence of S9-mix).
- No increase in the number of revertants was observed upon treatment with the test item under all conditions tested.
Second mutation experiment
- In tester strain TA1537, the test item precipitated on the plates at the highest tested dose level in the presence of S9-mix.
- In the second mutation assay, cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, was observed in the absence of S9-mix in tester strains TA1535, TA98, TA100 and WP2uvrA, and in the presence of S9-mix in tester strains TA1537 and TA100.
- In the second mutation assay, no increase in the number of revertants was observed upon treatment with X-21415 under all conditions tested.
Any other information on results incl. tables
Table 1 Dose-Range Finding Test: Mutagenic Response of X-21415 in the Salmonella typhimurium Reverse Mutation Assay and in the Escherichia coli Reverse Mutation Assay
(µg/plate) |
|
||
|
|
|
|
Without S9-mix
Positive control |
1668 |
± |
62 |
|
428 |
± |
5 |
|
|
|
|
|
Solvent control |
97 |
± |
6 |
|
21 |
± |
3 |
|
|
|
|
|
1.7 |
109 |
± |
15 |
|
23 |
± |
3 |
|
|
|
|
|
5.4 |
105 |
± |
20 |
|
19 |
± |
1 |
|
|
|
|
|
17 |
98 |
± |
9 |
|
24 |
± |
4 |
|
|
|
|
|
52 |
100 |
± |
6 |
|
20 |
± |
5 |
|
|
|
|
|
164 |
125 |
± |
14 |
|
15 |
± |
1 |
|
|
|
|
|
512 |
117 |
± |
19 |
|
16 |
± |
10 |
|
|
|
|
|
1600 |
71 |
± |
5 |
|
9 |
± |
6 |
|
|
|
|
|
5000 |
6 |
± |
4 |
n NP |
11 |
± |
5 |
n NP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
With S9-mix1
Positive control |
830 |
± |
24 |
|
1192 |
± |
127 |
|
|
|
|
|
Solvent control |
85 |
± |
19 |
|
16 |
± |
1 |
|
|
|
|
|
1.7 |
94 |
± |
6 |
|
15 |
± |
5 |
|
|
|
|
|
5.4 |
96 |
± |
22 |
|
14 |
± |
4 |
|
|
|
|
|
17 |
93 |
± |
6 |
|
12 |
± |
3 |
|
|
|
|
|
52 |
100 |
± |
14 |
|
14 |
± |
9 |
|
|
|
|
|
164 |
51 |
± |
1 |
n |
13 |
± |
2 |
|
|
|
|
|
512 |
12 |
± |
5 |
s |
15 |
± |
7 |
|
|
|
|
|
1600 |
|
|
e MC |
13 |
± |
2 |
|
|
|
|
|
|
5000 |
|
|
e NP MC |
15 |
± |
1 |
n NP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
Plate incorporation assay (5% S9) |
MC |
Microcolonies |
NP |
No precipitate |
e |
Bacterial background lawn extremely reduced |
n |
Normal bacterial background lawn |
s |
Bacterial background lawn slightly reduced |
Table 2. Experiment 1: Mutagenic Response of X-21415 in the Salmonella typhimurium Reverse Mutation Assay
(µg/plate) |
|
||
|
|
|
|
Without S9-mix
Positive control |
767 |
± |
5 |
|
1009 |
± |
101 |
|
1290 |
± |
138 |
|
Solvent control |
10 |
± |
2 |
|
3 |
± |
2 |
|
15 |
± |
5 |
|
17 |
7 |
± |
3 |
|
5 |
± |
2 |
|
16 |
± |
7 |
|
52 |
8 |
± |
3 |
|
2 |
± |
2 |
|
16 |
± |
3 |
|
164 |
7 |
± |
3 |
|
0 |
± |
1 |
|
13 |
± |
7 |
|
512 |
3 |
± |
1 |
|
1 |
± |
0 |
|
11 |
± |
3 |
|
1600 |
0 |
± |
1 |
NP |
1 |
± |
1 |
NP |
4 |
± |
3 |
NP |
5000 |
0 |
± |
1 |
n SP |
1 |
± |
1 |
n SP |
0 |
± |
0 |
n SP |
|
|
|
|
|
|
|
|
|
|
|
|
|
With S9-mix1
Positive control |
320 |
± |
24 |
|
251 |
± |
14 |
|
1035 |
± |
45 |
|
Solvent control |
6 |
± |
3 |
|
5 |
± |
2 |
|
18 |
± |
5 |
|
17 |
8 |
± |
1 |
|
3 |
± |
2 |
|
21 |
± |
4 |
|
52 |
7 |
± |
5 |
|
4 |
± |
1 |
|
19 |
± |
3 |
|
164 |
10 |
± |
2 |
|
6 |
± |
3 |
|
15 |
± |
1 |
|
512 |
7 |
± |
3 |
|
5 |
± |
5 |
|
23 |
± |
1 |
|
1000 |
6 |
± |
5 |
|
2 |
± |
2 |
|
16 |
± |
7 |
|
5000 |
2 |
± |
2 |
n NP |
11 |
± |
1 |
n NP |
2 |
± |
2 |
n NP |
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
Plate incorporation assay (5% S9) |
NP |
No precipitate |
SP |
Slight Precipitate |
n |
Normal bacterial background lawn |
Table 3. Experiment 2: Mutagenic Response of X-21415 in the Salmonella typhimurium Reverse Mutation Assay and in the Escherichia coli Reverse Mutation Assay
(µg/plate) |
|
||||
|
|
|
|
|
|
Without S9-mix
Positive control |
913 |
± |
42 |
|
956 |
± |
80 |
|
1485 |
± |
83 |
|
609 |
± |
15 |
|
925 |
± |
50 |
|
Solvent control |
5 |
± |
3 |
|
4 |
± |
3 |
|
7 |
± |
0 |
|
85 |
± |
8 |
|
17 |
± |
2 |
|
10 |
10 |
± |
4 |
|
3 |
± |
2 |
|
6 |
± |
3 |
|
67 |
± |
10 |
|
14 |
± |
5 |
|
50 |
5 |
± |
5 |
|
3 |
± |
2 |
|
10 |
± |
6 |
|
71 |
± |
17 |
|
14 |
± |
2 |
|
100 |
7 |
± |
3 |
|
4 |
± |
1 |
|
6 |
± |
5 |
|
68 |
± |
9 |
|
18 |
± |
3 |
|
500 |
2 |
± |
1 |
|
4 |
± |
5 |
|
7 |
± |
4 |
|
9 |
± |
9 |
|
12 |
± |
2 |
|
1000 |
3 |
± |
2 |
|
3 |
± |
4 |
|
4 |
± |
1 |
n |
2 |
± |
1 |
n |
16 |
± |
7 |
|
5000 |
0 |
± |
0 |
n NP |
4 |
± |
3 |
n NP |
|
|
e NP MC |
|
|
e NP MC |
9 |
± |
2 |
n NP |
With S9-mix1
Positive control |
246 |
± |
12 |
|
254 |
± |
46 |
|
666 |
± |
105 |
|
1327 |
± |
255 |
|
195 |
± |
27 |
|
Solvent control |
8 |
± |
2 |
|
4 |
± |
1 |
|
17 |
± |
6 |
|
73 |
± |
6 |
|
20 |
± |
3 |
|
10 |
10 |
± |
3 |
|
4 |
± |
1 |
|
14 |
± |
6 |
|
62 |
± |
3 |
|
23 |
± |
8 |
|
50 |
8 |
± |
2 |
|
3 |
± |
2 |
|
18 |
± |
2 |
|
78 |
± |
2 |
|
20 |
± |
3 |
|
100 |
8 |
± |
6 |
|
2 |
± |
1 |
|
13 |
± |
3 |
|
80 |
± |
19 |
|
25 |
± |
12 |
|
500 |
9 |
± |
2 |
|
4 |
± |
2 |
|
13 |
± |
3 |
|
79 |
± |
5 |
|
15 |
± |
1 |
|
1000 |
8 |
± |
3 |
|
2 |
± |
2 |
NP |
19 |
± |
5 |
|
81 |
± |
15 |
|
19 |
± |
6 |
|
5000 |
5 |
± |
2 |
n NP |
0 |
± |
0 |
n SP |
9 |
± |
6 |
n NP |
45 |
± |
7 |
n NP |
19 |
± |
4 |
n NP |
1 |
Plate incorporation assay (10% S9) |
MC |
Microcolonies |
NP |
No precipitate |
SP |
Slight Precipitate |
e |
Bacterial background lawn extremely reduced |
n |
Normal bacterial background lawn |
Applicant's summary and conclusion
- Conclusions:
- In an Ames test, performed according to OECD guideline 471 and in accordance with GLP principles, X-21415 was found to be not mutagenic with or without metabolic activation.
- Executive summary:
An Ames test was performed according to OECD guideline 471 and in accordance with GLP principles. The test item did not induce a dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in the tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in a follow-up experiment.
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate, and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that X-21415 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay with or without metabolic activation. Since all acceptibility criteria were met, the study was considered valid.
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