N-[3-(triethoxysilyl)propyl]ethylenediamine

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:

1994-10-19 to 1994-11-07

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were [4 strains only. Non-standard positive controls. only 2-aminoanthracene as +S9 control]

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1983

Deviations:

yes

Remarks:

4 strains only. Non-standard positive controls. only 2-aminoanthracene as +S9 control

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(triethoxysilyl)propyl]ethylenediamine

EC Number:

225-806-1

EC Name:

N-[3-(triethoxysilyl)propyl]ethylenediamine

Cas Number:

5089-72-5

Molecular formula:

C11H28N2O3Si

IUPAC Name:

N-[3-(triethoxysilyl)propyl]ethylenediamine

Method

Target gene:

His operon

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S9

Test concentrations with justification for top dose:

33.3, 100, 333.3, 1000, 2500 and 5000 µg/pate with and without metabolic activation

Vehicle / solvent:

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

- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

Untreated culture

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA 1535, TA 100 (without activation)

Controls 2

Untreated negative controls:

yes

Remarks:

Untreated culture

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylene-diamine

Remarks:

TA 1537, TA 98 (without activation)

Controls 3

Untreated negative controls:

yes

Remarks:

Untreated culture

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

All strains (with activation)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION

- Preincubation period: 60 minutes

- Exposure duration: 48 hours



NUMBER OF REPLICATIONS: 3 plates for each test concentration

DETERMINATION OF CYTOTOXICITY
- Method: background lawn assessment

Evaluation criteria:

A test article is considered mutagenic if in the strain TA 100 the number of reversions is at least twice as high and in strains TA 1535, TA 1537 and TA 98 at least three times higher as compared to the spontanious reversion rate. A dose dependant and reproducible increase in the number of revertants is an indication of possible existing mutagenic potential regardless of highest dose value.

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

- S9 (pre-incubation test): TA 98 and TA1537 at 5000 µg/plate, while TA 100 at 2500 µg/plate. + S9 (pre-incubation test): TA 1537 at 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Table 2: Dose range-finding study number of revertants per plate (2 plates per strain)

	TA 98			TA 100
Concentration (μg/Plate)	Plate 1 + MA	Plate 2 - MA	Cytotoxic (Yes/No)	Plate 1 + MA	Plate 2 - MA	Cytotoxic (Yes/No)
Negative control	15	17	No	163	122	No
0	24	16	No	147	129	No
3.3	12	17	No	150	128	No
10	22	20	No	154	116	No
33.3	18	12	No	158	120	No
100	19	19	No	155	119	No
333.3	21	14	No	87	107	No
1000	23	16	No	159	109	No
2500	20	13	No	128	111	No
5000	57	10	No	126	111	No
Positive control	555	142	No	973	353	No

*solvent control with ethanol

 

Table 3: Experiment 1 Mutagenicity Assay (plate incorporation) number of revertants per plate (mean of 3 plates)

	TA98			TA100			TA1535
Conc. (µg/plate)	— MA	+ MA	Cytotoxic (yes/no)	— MA	+ MA	Cytotoxic (yes/no)	— MA	+ MA	Cytotoxic (yes/no)
Negative control	17	15	No	122	163	No	13	13	No
0	16	24	No	129	147	No	14	19	No
33.3	12	18	No	120	158	No	15	16	No
100	19	19	No	119	155	No	15	16	No
333.3	14	21	No	107	87	No	13	15	No
1000	16	23	No	109	159	No	12	20	No
2500	13	20	No	111	128	No	11	19	No
5000	10	57	No	111	126	No	12	16	No
Positive control	142	555	No	353	973	No	69	405	No

*solvent control with ethanol

 

Table 3: Experiment 1 Mutagenicity Assay (plate incorporation ) number of revertants per plate (mean of 3 plates)

	TA1537
Conc. (µg/plate)	— MA	+ MA	Cytotoxic (yes/no)
Negative control	25	29	No
0	19	24	No
33.3	17	21	No
100	18	23	No
333.3	18	21	No
1000	20	22	No
2500	16	22	No
5000	14	22	No
Positive control	79	279	No

*solvent control with ethanol

 

Table 4: Experiment 2 Mutagenicity Assay (pre-incubation) Number of revertants per plate (mean of 3 plates)

	TA98			TA100			TA1535
Conc. (µg/plate)	— MA	+ MA	Cytotoxic (yes/no)	— MA	+ MA	Cytotoxic (yes/no)	— MA	+ MA	Cytotoxic (yes/no)
Negative control	27	39	No	130	136	No	10	13	No
0	31	38	No	103	122	No	17	19	No
33.3	27	36	No	92	129	No	12	19	No
100	28	42	No	105	126	No	11	15	No
333.3	29	32	No	94	122	No	12	19	No
1000	22	37	No	71	142	No	15	20	No
2500	18	31	No	9	91	Yes	10	13	No
5000	0	31	Yes	0	70	Yes	11	8	No
Positive control	218	287	No	808	389	No	862	122	No

*solvent control with Ethanol

 

Table 4: Experiment 2 Mutagenicity Assay (pre-incubation) number of revertants per plate (mean of 3 plates)

	TA1537
Conc. (µg/plate)	— MA	+ MA	Cytotoxic (yes/no)
Negative control	29	31	No
0	29	32	No
33.3	27	36	No
100	26	35	No
333.3	28	33	No
1000	27	35	No
2500	19	25	No
5000	8	4	Yes
Positive control	94	121	No

*solvent control with ethanol

MA: Metabolic activation

Applicant's summary and conclusion

Conclusions:

negative with metabolic activation
negative without metabolic activation

Under test conditions, no mutagenic effect was observed for the test substance tested up to limit concentration in any of the test strains in two independent experiments without and with metabolic activation. The test substance is non-mutagenic in test strains used.