Polysulfides, bis[3-(triethoxysilyl)propyl]

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In vitro genetic tioxicity studies have been conducted with bis[3-(triethoxysilyl)propyl]polysulfides (CAS No. 211519-85-6, EC No. 915-673-4) as follows:

Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without metabolic activation in S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA, (OECD Test Guideline 471) (Hita Laboratory, 2000b).

 

Cytogenicity in mammalian cells: negative with and without metabolic activation in CLU/IU cells (OECD Test Guideline 473) (Hita Laboratory, 2000c).

 

Mutagenicity in mammalian cells: negative with and without metabolic activation in L5178Y mouse lymphoma cells (OECD Test Guideline 476) (Harlan, 2009).

Link to relevant study records

Reference

Reference 1

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1997

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japan ministry of labour notifications 67

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

phenobarbitol and 5,6 benzoflavone induced rat liver S9

Test concentrations with justification for top dose:

4.88-5000 µg/plate (range finding expt), 156-5000 µg/plate main tests (pre-incubation)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: test substance is insoluble in water

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2(2-furyl)-3-(5-mitro-2-furyl)acrylamide

Remarks:

TA 100, TA 98 and E coli WP2 uvrA without activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA 1535 without activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino] acridine

Remarks:

TA 1537 without activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoacridine

Remarks:

all strains with activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
- Expression time (cells in growth medium): 48 h
- Fixation time (start of exposure up to fixation or harvest of cells): 48 h

NUMBER OF REPLICATIONS: test concentrations plated in triplicate, experiment repeated

DETERMINATION OF CYTOTOXICITY
- Method: other: inhibition of bacterial growth


ACTIVATION: 1 ML of S9 mix contained 8 µmol MgCL2, 33 µmol of KCl, 5 µmol of glucose-6-phosphate, 4 µmol of NADPH, 100 µmol of sodium phosphate buffer and 0.1 ml S9. 0.5 ml S9 was added to 0.1 ml test substance and 0.1 ml of bacterial culture medium was added to 2 ml of top agar, resulting in a final concentration of approximately 2% S9.

Evaluation criteria:

An increase in the number of revertants above twice that of the negative (solvent) control was judged to be a positive result.

Statistics:

No statistical treatment was done.

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True 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 nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True 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 nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True 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 nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive controls validity:

valid

Key result

Species / strain:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: hydrolyses in water
- Effects of osmolality: no information
- Evaporation from medium: no information
- Water solubility: hydrolyses in water
- Precipitation: observed at highest concentration
- Other confounding effects: none reported

RANGE-FINDING/SCREENING STUDIES: no cytotoxicity or genotoxicity observed


COMPARISON WITH HISTORICAL CONTROL DATA: comparable with historical data


ADDITIONAL INFORMATION ON CYTOTOXICITY: no inhibition of bacterial growth was observed

Table 2: Dose range-finding study. Number of revertants per plate (mean of 3 plates)

	TA100			TA1535			E coli WP2 uvrA
Conc. (µg/plate)	-MA	+ MA	Cytotoxic (yes/no)	-MA	+ MA	Cytotoxic (yes/no)	-MA	+ MA	Cytotoxic (yes/no)
0*	110	119	no	8	11	no	22	25	no
4.88	111	112	no	10	11	no	20	24	no
19.5	111	104	no	8	11	no	19	25	no
78.1	100	120	no	12	8	no	21	30	no
313	114	126	no	13	9	no	19	27	no
1250	116	114	no	10	14	no	23	31	no
+5000	117	122	no	9	7	no	24	29	no
Positive control	329	992	-	349	153	-	111	692	-

*solvent control with DMSO

 

Table 3: Dose range-finding study. Number of revertants per plate (mean of 3 plates)

	TA 98			TA1537
Conc. (µg/plate)	-MA	+ MA	Cytotoxic (yes/no)	-MA	+ MA	Cytotoxic (yes/no)
0*	19	32	no	8	16	no
4.88	18	29	no	9	19	no
19.5	18	34	no	8	20	no
78.1	21	26	no	9	20	no
313	24	27	no	10	17	no
1250	16	31	no	12	19	no
+5000	24	29	no	12	15	no
Positive control	398	264	-	22296	198	-

*solvent control with DMSO

 

Table 4: Experiment 1 Preincubation. Number of revertants per plate (mean of 3 plates)

	TA100			TA1535			E coli WP2 uvrA
Conc. (µg/plate)	-MA	+ MA	Cytotoxic (yes/no)	-MA	+ MA	Cytotoxic (yes/no)	-MA	+ MA	Cytotoxic (yes/no)
0*	110	124	no	15	12	no	17	28	no
156	109	101	no	17	11	no	19	23	no
313	102	95	no	18	13	no	22	29	no
625	118	104	no	18	14	no	19	28	no
1250	104	91	no	13	12	no	21	24	no
+2500	134	132	no	19	16	no	23	30	no
+5000	114	131	no	16	17	no	26	32	no
Positive control	422	912	-	447	115	-	121	887	-

*solvent control with DMSO

 

Table 5: Experiment 1 Preincubation. Number of revertants per plate (mean of 3 plates)

-	TA 98			TA1537
Conc. (µg/plate)	-MA	+ MA	Cytotoxic (yes/no)	-MA	+ MA	Cytotoxic (yes/no)
0*	15	29	no	9	15	no
156	18	34	no	5	16	no
313	21	34	no	6	17	no
625	19	30	no	8	10	no
1250	20	32	no	7	15	no
+2500	16	35	no	8	15	no
+5000	22	35	no	15	16	no
Positive control	384	273	-	2814	173	-

*solvent control with DMSO

 

Table 6: Experiment 2 Preincubation. Number of revertants per plate (mean of 3 plates)

-	TA100			TA1535			E coli WP2 uvrA
Conc. (µg/plate)	-MA	+ MA	Cytotoxic (yes/no)	-MA	+ MA	Cytotoxic (yes/no)	-MA	+ MA	Cytotoxic (yes/no)
0*	112	108	no	8	6	no	17	23	no
156	102	111	no	11	7	no	18	21	no
313	108	101	no	7	8	no	18	21	no
625	100	105	no	10	8	no	17	25	no
1250	110	114	no	7	11	no	14	18	no
+2500	100	110	no	8	7	no	18	23	no
+5000	105	109	no	7	9	no	23	26	no
Positive control	360	908	-	200	125	-	111	570	-

*solvent control with DMSO

 

Table 7: Experiment 2 Preincubation. Number of revertants per plate (mean of 3 plates)

-	TA 98			TA1537
Conc. (µg/plate)	-MA	+ MA	Cytotoxic (yes/no)	-MA	+ MA	Cytotoxic (yes/no)
0*	15	22	no	4	12	no
156	15	21	no	5	11	no
313	13	28	no	6	10	no
625	15	23	no	5	10	no
1250	17	20	no	4	11	no
+2500	17	23	no	6	13	no
+5000	18	24	no	7	12	no
Positive control	354	249	-	2665	173	-

*solvent control with DMSO

Conclusions:

Polysulfides (CAS 211519 -85 -9; EC 606-716-5) has been testing according to OECD Test Guideline 471 and in compliance with GLP. No increase in the number of reversions was observed in S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100 or E. coli WP2 uvrA, with or without metabolic activation, when tested up to limit concentrations. The initial and the repeat study used the preincubation method and the results were in agreement. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is not mutagenic to bacteria under the conditions of the test.

Reference 2

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-40-3 to 2000-07-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Version / remarks:

1997

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Kihatsu No 652 1997

Deviations:

no

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Species / strain / cell type:

mammalian cell line, other: Chinese hamster lung fibroblasts CHL/IU clone no. 11

Metabolic activation:

with and without

Metabolic activation system:

Phenobarbital and 5,6-benzoflavone activated rat liver S9

Test concentrations with justification for top dose:

50-200 µg/ml (main chromosome aberration test, 6 h exposure without activation); 50-150 µg/ml (main chromosome aberration test 6 h exposure with activation); 25-100 µg/ml (main chromosome aberration test, 24 h exposure without activation). Main cell growth inhibition tests conducted at: 50-800 µg/ml (6 h without activation), 50-400 µg/ml (6 h with activation), and 25-300 µg/ml (24 h without activation).

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO (dried)
- Justification for choice of solvent/vehicle: a stable suspension of test substance was obtained at 480 mg/ml. The test substance hydrolyses in water.

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

mitomycin C

Remarks:

without activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: cyclophosphamide monohydrate

Remarks:

with activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; preincubation;

DURATION
- Preincubation period: 6 hours
- Exposure duration: 6 hours short term tests, 24 hours continuous
- Expression time (cells in growth medium): 18 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 24 hours

SPINDLE INHIBITOR (cytogenetic assays): Colcemid added 2 h before completion of incubation
STAIN (for cytogenetic assays): 2% Giesma

NUMBER OF REPLICATIONS: Duplicate cultures at each dose

NUMBER OF CELLS EVALUATED: 200

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; inhibition of cell growth

OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: not recorded

ACTIVATION: 1 ml of S9 mix contained 0.3 ml of S9, 5 µmol of MgCl2, 33 µmol of KCl, 5 µmol of glucose-6-phosphates, 4 µmol of NADP and 4 µmol of buffer. 0.5 ml of S9 mix was added to a total volume of 3 ml, resulting in a final concentration of approximately 1.7% S9.

Evaluation criteria:

A results was judged positive when there is a 10% dose dependent increase in the frequency of cells with structural chromosomal aberration or 5% increase in the frequency of cells with polyploidy.

Statistics:

No statistical evaluation of results was carried out.

Key result

Species / strain:

mammalian cell line, other: CHL/IU clone 11

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

at 200 µg/ml

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 4800 µg/ml with and without activation during 6 h cell growth inhibition test dose setting, and at 200 µg/ml during main 6 h tests without activation

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Numbers in tables indicate the average number of aberrant cells per 100 cells, unless otherwise indicated

Table 2: Results of chromosome analysis: 6h exposure, 18 h recovery, without activation

-		Solvent Control	Positive Control	Low dose 50 µg/ml	Mid dose 100 µg/ml	High dose 200 µg/ml
Cytotoxicity		-	yes/no	no	no	yes
Precipitation		-	-	no	yes	yes
Chromatid aberrations	gaps	0	1.5	0	0	0
	breaks	0	23	0	0	0
	interchanges	0	42.5	0	0	0
Isochromatid aberrations	gaps	-	-	-	-	-
	breaks	0	0.5	0	0	1
	interchanges	0	1.5	0	0	0
Cell growth index		100%	NR	107.6%	67.9%	53.7%
Polyploidy		1%	0	2%	0	0
Endo reduplication		NR	NR	NR	NR	NR

 NR: Not reported

 

Table 3: Results of chromosome analysis: 6h exposure, 18 h recovery, with activation

-		Solvent Control	Positive Control	Low dose 50 µg/ml	Mid dose 100 µg/ml	High dose 150 µg/ml
Cytotoxicity		-	yes/no	no	no	yes
Precipitation		-	-	no	yes	yes
Chromatid aberrations	gaps	1.5	1.5	0	0.5	1.0
	breaks	0	15	0	0.5	3.0
	interchanges	0.5	22.5	0	2.0	2.5
Isochromatid aberrations	gaps	-	-	-	-	-
	breaks	0	0.5	0	0	0
	interchanges	0.5	0	0	0	0
Cell growth index		100%	NR	98.6%	73.4%	44.2%
Polyploidy		0.5%	0	2%	0	0
Endo reduplication		NR	NR	NR	NR	NR

NR: Not reported

 

Table 4: Results of chromosome analysis: continuous exposure

-	Solvent Control	Low dose 50 µg/ml	Mid dose 1  50 µg/ml	Mid dose 2 75 µg/ml	High dose 100 µg/ml
Cytotoxicity	-	no	no	yes	yes
Precipitation	-	no	no	yes	yes
Frequency of aberrant cells - structural	0	0	0	0	0
Cell growth index	100%	97.1%	72.3%	51.8%	38%
Polyploidy	4%	0	0	0	0
Endo reduplication	NR	NR	NR	NR	NR

NR: Not reported

Conclusions:

Polysulfides (CAS 211519 -85 -9; EC 606-716-5) has been tested in an in vitro chromosome aberration assay conducted in accordance with OECD Test Guideline 473 and in compliance with GLP. No substance-related increase in the number of aberrant cells was observed when tested up to cytotoxic concentrations with and without metabolic activation in Chinese hamster lung fibroblasts. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is not cytogenic to mammalian cells under the conditions of the test.

Reference 3

Endpoint:

in vitro gene mutation study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-08-11 to 2009-09-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes

Type of assay:

mammalian cell gene mutation assay

Species / strain / cell type:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Metabolic activation system:

phenobarbital/beta naphthoflavone induced rat liver S9

Test concentrations with justification for top dose:

0.31 to 20 μg/ml (4 and 24 h -S9); 5 to 60 μg/ml (4 h +S9)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Remarks:

without activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

with activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium


DURATION
- Preincubation period: none
- Exposure duration: 4 h (with and without activation) 24 hours (without activation
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): 10-14 days

SELECTION AGENT (mutation assays): 5-trifluorothymidine

NUMBER OF REPLICATIONS: cell cultures treated in duplicate

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; other: relative suspension growth; 2 day viability

OTHER: microwells used

ACTIVATION: 20% S9 mix contained S9, 8 mM of MgCl2, 33 mM of KCl, 5 mM of glucose-6-phosphate and 5 mM of NADP. The final concentration of S9 was 25 throughout the study.

Evaluation criteria:

A substance is judged to be positive if it produces a reproducible, dose-dependent, statistically significant increase in the mutant frequency relative to the vehicle control, by a factor that equals or exceeds the global evaluation value for the microwell method of 126 E-06.

Key result

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

25 µg/ml (4 and 24 h without activation)

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: at or above 194.19 µg/ml in all exposure groups

COMPARISON WITH HISTORICAL CONTROL DATA: control values were within historical control data

Table 1 Preliminary toxicity test

Dose (μg/ml)	% RSG (-S9) 4-Hour Exposure	% RSG (+S9) 4-Hour Exposure	% RSG (-S9) 24-Hour Exposure
0*	100	100	100
12.4	74	96	72
24.27	90	96	26
48.55	83	84	0
97.09	100	68	0
194.49	95	82	1
388.38	94	102	1
776.75	108	98	1
1553.5	100	102	4
3107	97	82	39

* solvent control with ethanol

Table 2 Main experiment Relative suspension growth, relative total growth and mutant frequency

Treatment µg/ml	4 hours - S9			Treatment µg/ml	4 hours + S9
	% RSG	RTG	MF		% RSG	RTG	MF
0*	100	1.00	89.99	0*	100	1.00	114.53
12.5	112	1.29	89.46	12.5	113	1.04	91.57
25	111	1.28	82.23	25	106	1.20	95.58
50	121	1.42	89.78	50	102	1.05	101.72
100**	110	1.28	79.77	100	105	1.09	93.79
150**	109	1.28	86.92	150**	104	1.10	88.74
200**	122	1.38	86.12	200**	106	1.17	98.22
Positive control	94	0.81	710.52	Positive control	65	0.29	935.61

RSG: Relative suspension growth,

RTG: relative total growth and mutant frequency

MF: mutant frequency

*Solvent control with ethanol

**Precipitate observed

Table 3 Main experiment Relative suspension growth, relative total growth and mutant frequency

Treatment µg/ml	24 hours - S9
	% RSG	RTG	MF
0*	100	1.00	96.68
1.56	109	NC	NC
3.13	102	0.95	108.38
6.25	101	1.29	76.85
12.5	104	1.21	113.47
18.75	89	1.02	93.93
25	59	0.69	89.8
37.5	16	0.14	141.03
50	9	NC	NC
Positive control	9	0.69	992.94

RSG: Relative suspension growth,

RTG: relative total growth and mutant frequency

MF: mutant frequency

NC not counted

*Solvent control with ethanol

Conclusions:

Polysulfides (CAS 211519 -85 -9; EC 606-716-5) has been tested for mutagenicity to mouse lymphoma L5178Y cells in a study according to OECD Test Guideline 476 and in compliance with GLP. No increase in the number of revertants was observed. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for the mutagenicity in mammalian cells under the conditions of the test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The key bacterial mutagenicity study with bis[3-(triethoxysilyl)propyl]polysulfides was conducted according to OECD Test Guideline 471 and in compliance with GLP (Hita Laboratory, 2000b). No increase in the number of reversions was observed in S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100 or E. coli WP2 uvrA, with or without metabolic activation, when tested up to limit concentration. The initial and the repeat study used the preincubation method and the results were in agreement. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is not mutagenic to bacteria under the conditions of the test.

 

This key result is supported by an older study of similar reliability (Microbiological Associates, 1996) which tested S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA using the plate incorporation method. A further study of lower reliability used S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 1538 (TNO, 1988). Both the supporting studies gave negative results with and without metabolic activation.

 

In the key in vitro chromosome aberration assay with bis[3-(triethoxysilyl)propyl]polysulfides conducted according to OECD Test Guideline 473 and in compliance with GLP (Hita Laboratory, 2000c), no substance-related increase in the number of aberrant cells was observed when tested up to cytotoxic concentrations with and without metabolic activation in Chinese hamster lung fibroblasts. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is not cytogenic to mammalian cells under the conditions of the test.

 

The key mammalian cell mutagenicity test was conducted according to OECD Test Guideline 476 and in compliance with GLP (Harlan, 2009). Mouse lymphoma L5178Y cells were used in the study. No increase in the number of revertants was observed with and without metabolic activation when tested up to cytotoxic concentrations. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for the mutagenicity in mammalian cells under the conditions of the test.

 

No evidence genetic toxicity potential was observed in the in vitro studies, so in vivo testing is not required.

Justification for classification or non-classification

Based on the available in vitro genotoxicity data, polysulfides, bis[3-(triethoxysilyl)propyl] does not require classification for mutagenicity according to Regulation (EC) No 1272/2008.