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EC number: 231-303-8 | CAS number: 7488-56-4
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Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Genetic toxicity in vitro - Bacterial Reverse Mutation Assay
Selenium Disulphide is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 July 2018 - 01 August 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- GLP study conducted to recent guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Identification: Selenium Disulphide
Batch: PMC/285/16
CAS No.: 7488-56-4
EINECS No. / EC No.: 231-303-8
Purity: 100%
Physical State / Appearance: Solid, orange
Expiry Date: 24 November 2026
Storage Conditions: At room temperature
Stability in Solvent: Not indicated by the Sponsor - Target gene:
- Histidine and tryptophan
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/β-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- In the pre-experiment the concentration range of the test item was 3 – 5000 μg/plate. The pre-experiment is reported as experiment I. Since no relevant toxic effects were observed 5000 μg/plate was chosen as maximal concentration. The concentration range included two logarithmic decades.
The following concentrations were tested in experiment II:
All strains with and without S9 mix: 33; 100; 333; 1000; 2500; and 5000 μg/plate
Due to a weak increase in revertant rates with TA 98 in the absence of S9 mix a confirmatory experiment with closer spacing was performed.
Experiment IIa:
Strain TA 98 without S9 mix: 658; 988; 1481; 2222; 3333; and 5000 μg/plate - Vehicle / solvent:
- 1% [w/v] Methylcellulose in deionized water
In a preliminary solubility trial several solvents (e.g. deionised water, DMSO, ethanol, acetone, DMF, THF and 1% [w/v] Methylcellulose) were used to find a suitable one to prepare an applicable test item preparation. The test item showed a low solubility in all solvents. However, 1% (w/v) Methylcellulose in deionised water was found to be the most suitable one which led to a fine suspension of the test item which appeared to be homogeneous. On the day of the experiment, the test item Selenium Disulphide was suspended in 1% [w/v] Methylcellulose in deionized water. To obtain a fine suspension a porcelain mortar was used (for details see raw data). The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria (Maron et al.; 1981).
All formulations were prepared freshly before treatment and used within two hours of preparation. - Untreated negative controls:
- other:
- Remarks:
- Based on historical data
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Vehicle only
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine; 2-aminoanthracene
- Details on test system and experimental conditions:
- Pre-Experiment for Toxicity
To evaluate the toxicity of the test item a pre-experiment was performed with all strains used. Eight concentrations were tested for toxicity and mutation induction with each 3 plates. The experimental conditions in this pre-experiment were the same as described for the experiment I below (plate incorporation test).
Toxicity of the test item results in a reduction in the number of spontaneous revertants (below a factor of 0.5) or a clearing of the bacterial background lawn.
Dose Selection
In the pre-experiment the concentration range of the test item was 3 – 5000 μg/plate. The pre-experiment is reported as experiment I. Since no relevant toxic effects were observed 5000 μg/plate was chosen as maximal concentration. The concentration range included two logarithmic decades.
The following concentrations were tested in experiment II:
All strains with and without S9 mix: 33; 100; 333; 1000; 2500; and 5000 μg/plate
Due to a weak increase in revertant rates with TA 98 in the absence of S9 mix a confirmatory experiment with closer spacing was performed.
Experiment IIa:
Strain TA 98 without S9 mix: 658; 988; 1481; 2222; 3333; and 5000 μg/plate
Experimental Performance
For each strain and dose level, including the controls, three plates were used.
Experiment I (Plate Incorporation)
The following materials were mixed in a test tube and poured onto the selective agar plates:
100 μL Test solution at each dose level (solvent or reference mutagen solution (positive control)),
500 μL S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test without metabolic activation),
100 μL Bacteria suspension.
2000 μL Overlay agar
Experiment II and IIa (Pre-Incubation)
The following materials were mixed in a test tube and incubated at 37°C for 60 minutes.
100 μL Test solution at each dose level (solvent or reference mutagen solution (positive control)),
500 μL S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test without metabolic activation),
100 μL Bacteria suspension (cf. 3.4.3 Precultures),
After pre-incubation 2.0 mL overlay agar (45°C) was added to each tube.
The mixture was poured on minimal agar plates. After solidification the plates were incubated upside down for at least 48 hours at 37°C in the dark.
In parallel to each test a sterile control of the test item was performed and documented in the raw data. Therefore, 100 μL of the stock solution, 500 μL S9 mix / S9 mix substitution buffer were mixed with 2.0 mL overlay agar and poured on minimal agar plates. - Rationale for test conditions:
- The test conditions were based on the OECD/EU test guidelines
- Evaluation criteria:
- The Salmonella typhimurium and Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
• regular background growth in the negative and solvent control;
• the spontaneous reversion rates in the negative and solvent control are in the range of our historical data;
• the positive control substances should produce an increase above the threshold of twofold (strains TA 98, TA 100, and WP2 uvrA) or threefold (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control;
• a minimum of five analysable dose levels should be present with at least three dose levels showing no signs of toxic effects, evident as a reduction in the number of revertants below the indication factor of 0.5.
A test item is considered as a mutagen if a biologically relevant increase in the number of revertants of twofold or above (strains TA 98, TA 100, and WP2 uvrA) or threefold or above (strains TA 1535 and TA 1537) the spontaneous mutation rate of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is reached or exceeded at more than one concentration.
An increase of revertant colonies equal or above the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - 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 applicable
- 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 applicable
- 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 applicable
- 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 applicable
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test item Selenium Disulphide was assessed for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II and IIa) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in three independent experiments with and/or without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: All strains with and without S9 mix: 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment II: All strains with and without S9 mix: 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment IIa:
Strain TA 98 without S9 mix: 658; 988; 1481; 2222; 3333; and 5000 μg/plate
The test item precipitated in the overlay agar in the test tubes from 333 to 5000 μg/plate in experiment I and II and from 658 to 5000 μg/plate in experiment IIa. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 2500 to 5000 μg/plate in experiment I and II and from 3333 to 5000 μg/plate in experiment IIa.
The plates incubated with the test item showed normal background growth up to 5000 μg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation.
No substantial increase in revertant colony numbers of any of the four tester strains TA 1535, TA 1537, TA 100, and E.coli WP2 uvrA was observed following treatment with Selenium Disulphide at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix).
In addition, tester strain TA 98 showed no relevant increase in revertant rates in experiment I in the absence and presence of metabolic activation and in experiment II in the presence of metabolic activation.
In experiment II in the absence of S9 mix a dose-related increase in revertant colony numbers was obtained with TA 98. At 5000 μg/plate the revertant rate (58.7 revertants per plate; factor 2.1) exceeded the range of the historical negative control data (13 – 43 revertants per plate) and slightly exceeded the threshold of twofold compared to the respective solvent control (28.0 revertants per plate). This observation occurred at a dose which showed fine precipitates on the agar plates. In this experiment scoring was done automatically whereas in the previous experiment I manual scoring of TA 98 and TA 100 colony numbers was done at high doses due to discrepancies between the values measured by the automatic scoring system and the colony counts on the plates determined by eye. Since scoring bias could not be excluded, and in accordance with the evaluation criteria defined in 3.7.3, a confirmatory experiment, designated experiment IIa, was performed to corroborate the finding in experiment II. A closer dose spacing (dilution factor 1.5) was applied in the repeat experiment with TA 98 in the absence of metabolic activation. In experiment IIa no biologically relevant increase in revertant rates was observed when tested up to the highest required dose of 5000 μg/plate. The highest revertant colony number was obtained at the top dose of 5000 μg/plate (39.0 revertants per plate). This value was clearly within the range of the historical negative control data (13 – 43 revertants per plateand below the threshold of twofold compared to the respective solvent control (23.3 revertants per plate). Fine precipitation of the test item onto the plates was observed at 3333 and 5000 μg/plate. The revertant colonies of these two dose groups were scored manually to prevent misleading data due to possible interference with precipitates.
Finally, the observation of a slight increase in revertant rates in TA 98 in the absence of S9 mix was not reproduced in the confirmatory experiment IIa with narrow dose setting. The observation in experiment II occurred only at a dose which showed fine precipitates onto the agar plates while scored automatically. In experiment I and IIa the colony numbers were scored manually to prevent misleading data due to possible interference with precipitation. Thus, it cannot be precluded that the slightly increased revertant rates in experiment II are based on erroneous automatic scoring procedure. In accordance with the evaluation criteria, due to the lack of reproducibility in the findings in experiment II in tester strain TA 98 in the absemce of S9 mix has to be regarded as not biologically relevant.
Appropriate reference mutagens were used as positive controls. They showed a distinct in-crease in induced revertant colonies. - Conclusions:
- In conclusion, it can be stated that during the described 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:
The test item Selenium Disulphide was assessed for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II and IIa) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2uvrA.
The assay was performed in three independent experiments with and/or without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I (plate incorporation assay): All strains with and without S9 mix: 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment II (pre-incubation assay): All strains with and without S9 mix: 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment IIa (pre-incubation assay):
Strain TA 98 without S9 mix: 658; 988; 1481; 2222; 3333; and 5000 μg/plate
The test item precipitated in the overlay agar in the test tubes from 333 to 5000 μg/plate in experiment I and II and from 658 to 5000 μg/plate in experiment IIa. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 2500 to 5000 μg/plate in experiment I and II and from 3333 to 5000 μg/plate in experiment IIa.
The plates incubated with the test item showed normal background growth up to 5000 μg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in any strains with and without metabolic activation.
No relevant increase in revertant colony numbers was observed with the four tester strains TA 1535, TA 1537, TA 100, and E.coli WP2uvrA following treatment with Selenium Disulphide at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix).
In addition, tester strain TA 98 showed no relevant increase in revertant rates in experiment I in the absence and presence of metabolic activation and in experiment II in the presence of metabolic activation. However, in experiment II in the absence of S9 mix the exposure with the test item led to a dose-related, slight increase in revertant colony numbers in TA 98 at the highest required dose. The finding occurred at a dose causing strong precipitation. Thus, it cannot be precluded that the slightly increased revertant rates in experiment II at top dose are based on the interference of the fine precipitates with scoring. Because of this finding, and in accordance with the evaluation criteria, this part of the experiment was repeated as experiment IIa.
No relevant increase in mutation was observed in the confirmatory experiment performed with TA 98 under identical experimental conditions, but with a closer dose spacing and manual scoring of mutant colonies at high doses.
Therefore, due to lacking reproducibility the finding in experiment II in tester strain TA 98 in the absence of S9 mix has to be regarded as not biologically relevant.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described 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.
Therefore, Selenium Disulphide is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
Reference
Summary of Experiment I |
||||||||||
Metabolic |
Test |
Dose Level |
Revertant Colony Counts (Mean ± SD) |
|
||||||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|||
Without Activation |
1% Methylcellulose |
9 ± 3 |
11 ± 1 |
26 ± 6 |
188 ± 5 |
44 ± 6 |
||||
Untreated |
12 ± 4 |
14 ± 6 |
27 ± 1 |
180 ± 12 |
42 ± 11 |
|||||
|
Selenium |
3 µg |
10 ± 1 |
12 ± 3 |
29 ± 7 |
186 ± 23 |
44 ± 11 |
|||
|
Disulphide |
10 µg |
13 ± 3 |
11 ± 2 |
26 ± 9 |
177 ± 19 |
45 ± 3 |
|||
|
33 µg |
9 ± 2 |
10 ± 2 |
28 ± 3 |
189 ± 7 |
45 ± 4 |
||||
|
100 µg |
11 ± 3 |
12 ± 3 |
27 ± 7 |
182 ± 25 |
48 ± 7 |
||||
|
333 µg |
11 ± 3 |
11 ± 1 |
29 ± 8 |
190 ± 28 |
39 ± 6 |
||||
|
1000 µg |
12 ± 3 |
10 ± 0 |
33 ± 4 |
183 ± 7 |
47 ± 15 |
||||
|
2500 µg |
7 ± 2P |
16 ± 5P |
37 ± 2P M |
204 ± 5P M |
43 ± 16P |
||||
|
5000 µg |
10 ± 3P |
17 ± 3P |
41 ± 5P M |
237 ± 5P M |
51 ± 9P |
||||
|
NaN3 |
10 µg |
1168 ± 65 |
1797 ± 254 |
||||||
|
4-NOPD |
10 µg |
426 ± 21 |
|||||||
|
4-NOPD |
50 µg |
74 ± 13 |
|||||||
|
MMS |
2.0 µL |
814 ± 83 |
|||||||
With Activation |
1% Methylcellulose |
11 ± 1 |
14 ± 3 |
48 ± 8 |
206 ± 3 |
54 ± 12 |
||||
Untreated |
12 ± 4 |
13 ± 3 |
48 ± 1 |
214 ± 4 |
54 ± 10 |
|||||
|
Selenium |
3 µg |
12 ± 3 |
12 ± 3 |
42 ± 8 |
173 ± 25 |
50 ± 3 |
|||
|
Disulphide |
10 µg |
11 ± 4 |
13 ± 6 |
46 ± 4 |
189 ± 11 |
43 ± 5 |
|||
|
33 µg |
11 ± 4 |
13 ± 1 |
49 ± 8 |
202 ± 16 |
50 ± 5 |
||||
|
100 µg |
13 ± 2 |
12 ± 3 |
39 ± 4 |
191 ± 21 |
51 ± 10 |
||||
|
333 µg |
13 ± 2 |
14 ± 2 |
45 ± 10 |
202 ± 19 |
44 ± 4 |
||||
|
1000 µg |
11 ± 1 |
16 ± 4 |
49 ± 5 |
187 ± 12 |
39 ± 8 |
||||
|
2500 µg |
11 ± 1P |
18 ± 6P |
38 ± 3P M |
160 ± 2P M |
44 ± 5P |
||||
|
5000 µg |
12 ± 2P |
13 ± 3P |
35 ± 2P M |
195 ± 8P |
51 ± 5P |
||||
|
2-AA |
2.5 µg |
211 ± 21 |
414 ± 17 |
2280 ± |
3770 ± 167 |
||||
|
2-AA |
10.0 µg |
217 ± 21 |
|||||||
Key to Positive Controls |
Key to Plate Postfix Codes |
|||||||||
NaN3 2-AA |
sodium azide |
P M |
Precipitate Manual count |
|||||||
Summary of Experiment II |
||||||||||
Metabolic |
Test |
Dose Level |
Revertant Colony Counts (Mean ± SD) |
|
|
|||||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|||
Without Activation |
1% Methylcellulose |
10 ± 1 |
19 ± 3 |
28 ± 8 |
209 ± 5 |
53 ± 2 |
||||
Untreated |
16 ± 4 |
20 ± 6 |
29 ± 8 |
199 ± 27 |
62 ± 7 |
|||||
Selenium |
33 µg |
10 ± 4 |
21 ± 4 |
28 ± 8 |
203 ± 29 |
49 ± 3 |
||||
Disulphide |
100 µg |
12 ± 3 |
23 ± 6 |
22 ± 6 |
194 ± 11 |
58 ± 5 |
||||
333 µg |
9 ± 2 |
21 ± 5 |
20 ± 4 |
215 ± 10 |
43 ± 11 |
|||||
1000 µg |
11 ± 5 |
21 ± 5 |
22 ± 2 |
220 ± 23 |
57 ± 3 |
|||||
2500 µg |
9 ± 1P |
20 ± 7P |
40 ± 12P |
249 ± 17P |
51 ± 5P |
|||||
5000 µg |
11 ± 1P |
27 ± 0P |
59 ± 1P |
278 ± 17P |
58 ± 11P |
|||||
NaN3 |
10 µg |
1241 ± 8 |
1641 ± |
|||||||
4-NOPD |
10 µg |
399 ± 36 |
||||||||
4-NOPD |
50 µg |
100 ± 5 |
||||||||
MMS |
2.0 µL |
803 ± 42 |
||||||||
With Activation |
1% Methylcellulose |
11 ± 2 |
24 ± 3 |
39 ± 5 |
204 ± 19 |
65 ± 6 |
||||
Untreated |
12 ± 2 |
25 ± 4 |
42 ± 10 |
213 ± 9 |
70 ± 3 |
|||||
Selenium |
33 µg |
11 ± 1 |
24 ± 2 |
35 ± 7 |
202 ± 20 |
47 ± 5 |
||||
Disulphide |
100 µg |
13 ± 6 |
26 ± 2 |
34 ± 3 |
213 ± 5 |
48 ± 6 |
||||
333 µg |
12 ± 2 |
23 ± 3 |
41 ± 6 |
202 ± 12 |
53 ± 5 |
|||||
1000 µg |
11 ± 2 |
21 ± 2 |
35 ± 5 |
206 ± 26 |
51 ± 7 |
|||||
2500 µg |
13 ± 2P |
25 ± 5P |
38 ± 7P |
213 ± 17P |
50 ± 8P |
|||||
5000 µg |
14 ± 1P |
22 ± 3P |
46 ± 5P |
222 ± 25P |
63 ± 5P |
|||||
2-AA |
2.5 µg |
182 ± 25 |
248 ± 28 |
1673 ± |
2410 ± |
|||||
2-AA |
10.0 µg |
200 ± 23 |
||||||||
Key to Positive Controls |
Key to Plate Postfix Codes |
|||||||||
NaN3 |
sodium azide |
P |
Precipitate |
|||||||
2-AA |
2-aminoanthracene |
|||||||||
4-NOPD |
4-nitro-o-phenylene-diamine |
|||||||||
MMS |
methyl methane sulfonate |
|||||||||
Summary of Experiment IIa |
||||||
Metabolic |
Test |
Dose Level |
Revertant Colony Counts (Mean ± SD) |
|||
|
|
|
TA 98 |
|||
Without Activation |
1% Methylcellulose |
|
23 ± 3 |
|||
Untreated |
|
27 ± 7 |
||||
|
Selenium Disulphide |
658 µg |
26 ± 7 |
|||
|
|
988 µg |
26 ± 4 |
|||
|
|
1481 µg |
32 ± 5 |
|||
|
|
2222 µg |
38 ± 2 |
|||
|
|
3333 µg |
32 ± 4P M |
|||
|
|
5000 µg |
39 ± 3P M |
|||
|
4-NOPD |
10 µg |
471 ± 10 |
|||
Key to Positive Controls |
Key to Plate Postfix Codes |
|||||
4-NOPD |
4-nitro-o-phenylene-diamine |
P M |
Precipitate Manual count |
|||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Genetic toxicity in vitro - Bacterial Reverse Mutation Assay
The test item Selenium Disulphide was assessed for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II and IIa) usingSalmonella typhimuriumstrains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2uvrA.
The assay was performed in three independent experiments with and/or without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I (plate incorporation assay): All strains with and without S9 mix: 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment II (pre-incubation assay): All strains with and without S9 mix: 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment IIa (pre-incubation assay):
Strain TA 98 without S9 mix: 658; 988; 1481; 2222; 3333; and 5000 μg/plate
The test item precipitated in the overlay agar in the test tubes from 333 to 5000 μg/plate in experiment I and II and from 658 to 5000 μg/plate in experiment IIa. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 2500 to 5000 μg/plate in experiment I and II and from 3333 to 5000 μg/plate in experiment IIa.
The plates incubated with the test item showed normal background growth up to 5000 μg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in any strains with and without metabolic activation.
No relevant increase in revertant colony numbers was observed with the four tester strains TA 1535, TA 1537, TA 100, and E.coli WP2uvrA following treatment with Selenium Disulphide at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix).
In addition, tester strain TA 98 showed no relevant increase in revertant rates in experiment I in the absence and presence of metabolic activation and in experiment II in the presence of metabolic activation. However, in experiment II in the absence of S9 mix the exposure with the test item led to a dose-related, slight increase in revertant colony numbers in TA 98 at the highest required dose. The finding occurred at a dose causing strong precipitation. Thus, it cannot be precluded that the slightly increased revertant rates in experiment II at top dose are based on the interference of the fine precipitates with scoring. Because of this finding, and in accordance with the evaluation criteria, this part of the experiment was repeated as experiment IIa.
No relevant increase in mutation was observed in the confirmatory experiment performed with TA 98 under identical experimental conditions, but with a closer dose spacing and manual scoring of mutant colonies at high doses.
Therefore, due to lacking reproducibility the finding in experiment II in tester strain TA 98 in the absence of S9 mix has to be regarded as not biologically relevant.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described 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.
Therefore, Selenium Disulphide is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
Justification for classification or non-classification
Based on the available data and in accordance with Regulation (EC) 1272/2008, Selenium Disulphide does not meet the classification criteria for mutagenicity.
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