N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine

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:

1982-01-12 to 1982-01-22

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

strains - no Ecoli or 102, non-standard control for TA 98

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine

EC Number:

252-390-9

EC Name:

N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine

Cas Number:

35141-30-1

Molecular formula:

C10H27N3O3Si

IUPAC Name:

3,3-dimethoxy-2-oxa-7,10-diaza-3-siladodecan-12-amine

Method

Target gene:

his operon

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S9

Test concentrations with justification for top dose:

See table 1

Vehicle / solvent:

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

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

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylenediamine

Remarks:

TA 98, TA 1538 (without activation)

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA 1537 (without activation)

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA 100, TA 1535 (without activation)

Controls 4

Untreated negative controls:

yes

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)


DURATION
- Expression time (cells in growth medium): 48-72 hours

NUMBER OF REPLICATIONS: 3 plates for each test concentration

DETERMINATION OF CYTOTOXICITY
- Method: Monitoring of background lawn growth / spontanious mutant frequency

Evaluation criteria:

The test substance is considered positive if the number of revertant colonies is at least twice that of the solvent control for at least one dose level,
and there is a dose related increase in the number of revertant colonies. Positive results must be reproducible.

Solvent controls must be within range of historical data

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

10ug/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

10ug/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data

Any other information on results incl. tables

Table 2: Experiment 1 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**	19	19	No	126	126	No	46	46	No
0*	17	26	No	136	85	No	41	13	No
0.1	12	16	No	110	80	No	52	11	No
0.3	9	19	No	130	76	No	50	14	No
1	14	21	No	79	64	No	32	6	No
3	5	11	No	28	54	No	12	7	No
10	-	7	Yes	-	26	Yes	-	4	Yes
Positive control	817	1549	No	1895	1171	No	1945	74	No

*solvent control with DMSO

**negative control with methanol

Table 2: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)

	TA1537			TA1538
Conc. (µg/plate)	— MA	+ MA	Cytotoxic (yes/no)	— MA	+ MA	Cytotoxic (yes/no)
Negative control**	4	4	No	10	10	No
0*	4	5	No	9	16	No
0.1	2	4	No	6	16	No
0.3	2	4	No	7	15	No
1	3	3	No	4	12	No
3	2	4	No	3	7	No
10	-	1	Yes	-	1	Yes
Positive control	82	88	No	992	264	No

*solvent control with DMSO

**negative control with methanol

Applicant's summary and conclusion

Conclusions:

No mutagenic effect was observed for the submission substance tested up to cytotoxic concentration in any of the test strains in two independent experiments without and with metabolic activation. The submission substance is non-mutagenic in the test strains used.