Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data was taken from secondary source
Data source
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Bacterial Reverse Mutation Assay was carried out for the RA chemical
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
- EC Number:
- 217-164-6
- EC Name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
- Cas Number:
- 1760-24-3
- Molecular formula:
- C8H22N2O3Si
- IUPAC Name:
- (2-Aminoethyl)(3-(trimethoxysilyl)propyl)amine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Not specified
Method
- Target gene:
- Histidine operon (S. typhimurium strains); tryptophan operon (E. coli).
Species / strain
- Species / strain / cell type:
- other: S. typhimurium, other: TA97, TA98 and TA100
- Details on mammalian cell type (if applicable):
- Not specified
- Additional strain / cell type characteristics:
- other: Not specified
- Cytokinesis block (if used):
- Not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
Aroclor 1254 induced rat liver S9- Test concentrations with justification for top dose:
- 8, 40, 200, 1000 and 5000 µg/plate
- Vehicle / solvent:
- Ethylene glycol dimethyl ether (EGDME)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
TA100 without metabolic activation 100 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
TA1535 without metabolic activation 10000 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
TA1537 without metabolic activation 50 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98, TA1538 without metabolic activation 1 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 2 days
NUMBER OF REPLICATIONS: five replicates
DETERMINATION OF CYTOTOXICITY
- Method: condition of background lawn - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- Not specified
- Statistics:
- Not specified
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No mutagenic potential was observed in any strain at any dose concentration
- Remarks on result:
- other: No mutagenic potential was observed in any strain at any dose concentration
Applicant's summary and conclusion
- Conclusions:
N-(3-(trimethoxysilyl)propyl)ethylenediamine has been tested for mutagenicity to bacteria in a study which was conducted according to OECD 471 but did not include TA102 or E.coli, compliant with GLP. No evidence of a test substance related increase in the number of revertants was observed with or without activation in the experiment. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.- Executive summary:
Genetic toxicity study as per OECD guideline 471 (Bacterial Reverse Mutation Assay) was carried out for the RA chemical N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS number 1760-24-3).
During this test various strains were used TA98, TA100, TA1535, TA1537, and TA1538 at a dose range of 8, 40, 200, 1000 and 5000 µg/plate at metabolic activation factor Aroclor 1254 induced rat liver S9. Positive control substances are used methylmethanesulfonate,2-nitrofluorene,9-aminoacridine, and ethylmethanesulphonate by using the agar plate method.
After a complete analysis of the results the RA chemical which is structurally similar to test chemical
N-(3-(trimethoxysilyl)propyl)ethylenediamine has been tested for mutagenicity to bacteria in a study which was conducted according to OECD 471 but did not include TA102 or E.coli, compliant with GLP. No evidence of a test substance related increase in the number of revertants was observed with or without activation in the experiment. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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