Dichloromethyl(3,3,4,4,5,5,6,6,6-nonafluorohexyl)silane

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-05-13 to 1986-05-16

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No duplicate plates; no historical data; insufficient detail on S9 preparation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

no duplicate plates

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dichloromethyl(3,3,4,4,5,5,6,6,6-nonafluorohexyl)silane

EC Number:

253-930-6

EC Name:

Dichloromethyl(3,3,4,4,5,5,6,6,6-nonafluorohexyl)silane

Cas Number:

38436-16-7

Molecular formula:

C7H7Cl2F9Si

IUPAC Name:

Dichloro(methyl)(3,3,4,4,5,5,6,6,6-nonafluorohexyl)silane

Constituent 2

Reference substance name:

[2-(perfluorobutyl)ethyl]dichloro(methyl)silane

IUPAC Name:

[2-(perfluorobutyl)ethyl]dichloro(methyl)silane

Details on test material:

[2-(perfluorobutyl)ethyl]dichloro(methyl)silane

Method

Target gene:

histidine operon (Salmonella typhimurium strains); tryptophan operon (E. coli strain)

Species / strain

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:

Aroclor induced rat liver S9

Test concentrations with justification for top dose:

78.12, 156.25, 312.5, 625, 1250 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: none given in study report

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

10 μg/plate; strains TA 100, TA 1535; without metabolic activation

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: daunomycin

Remarks:

10 μg/plate; strain TA 98; without metabolic activation

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

10 μg/plate; strain TA 1537; without metabolic activation

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: n-methyl-n-nitro-n-nitrosoguanidine

Remarks:

10 μg/plate; strain WP2; without metabolic activation

Controls 5

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-anthramine

Remarks:

10 μg/plate; strains TA 1535, WP2; with metabolic activation

Controls 6

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminofluorene

Remarks:

10 μg/plate; strains TA 1537, TA-98, TA-100; with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); other: spotted onto surface of agar

ACTIVATION: Aroclor induced rat liver S9; co-factors and concentration in plates not indicated in report

DURATION
- Exposure duration: 72 hours

SELECTION AGENT (mutation assays): histidine (Salmonella strains) or tryptophan (E. coli) deficient agar

NUMBER OF REPLICATIONS: An initial spot test was followed by a plate incorporation assay.

DETERMINATION OF CYTOTOXICITY
- Method: no information

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

1250 μg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Any other information on results incl. tables

	TA-1535		TA-1537		TA-98		TA-100		WP2
Concentration (μg/plate)	-  MA	+ MA	- MA	+ MA	- MA	+ MA	- MA	+ MA	- MA	+ MA
Solvent control	15	15	5	9	23	23	160	122	28	26
Positive Control	559	382	117	212	326	376	671	445	226	246
78.12	16	12	5	8	21	23	146	116	30	22
156.25	14	13	4	7	20	23	151	128	27	25
312.5	17	10	4	10	22	22	130	137	20	27
625	12	11	4	5	19	19	101	114	23	22
1250	6	7	1	1	12	6	67	72	14	4

Applicant's summary and conclusion

Conclusions:

[2-(perfluorobutyl)ethyl]dichloro(methyl)silane has been tested for mutagenicity to bacteria, in a study which was conducted according to a protocol that is similar to OECD 471, and in compliance with GLP (Dow Corning Corporation, 1986). No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or E. coli WP2 in the initial spot test for toxicity or the repeat experiment conducted using the plate incorporation method, when tested up to cytotoxic concentrations. Appropriate positive and solvent controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.