Registration Dossier
Registration Dossier
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EC number: 904-139-6 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Notice of filing of a pesticide petition to establish a tolerance for a certain pesticide chemical in or on food
- Author:
- Anon.
- Year:
- 2 001
- Bibliographic source:
- US Federal Register Vol. 66, No. 4, pages 1129-1135
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
- Principles of method if other than guideline:
- - Principle of test:
Ames test utilising Salmonella typhimurium and Saccharomyces cerevisiae.
- Short description of test conditions: Plate tests and suspension tests were performed with the indicator strains of both test organisms. Concentrations from 0.4 to 1.7% were employed as the dose levels in the mutagenicity assays, these based upon the outcome of preliminary cytotoxicity studies. - GLP compliance:
- no
- Remarks:
- study pre-dates the introduction of GLP
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Triethyl citrate
- EC Number:
- 201-070-7
- EC Name:
- Triethyl citrate
- Cas Number:
- 77-93-0
- Molecular formula:
- C12H20O7
- IUPAC Name:
- triethyl 2-hydroxypropane-1,2,3-tricarboxylate
- Test material form:
- liquid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- Saccharomyces cerevisiae
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from mouse, rat and monkey livers
Controlsopen allclose all
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: quinacrine mustard
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- -S9
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- N-dimethylnitrosamine
- Remarks:
- +S9
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Remarks:
- +S9
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 8-aminoquinoline
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthacene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and in suspension
- Cell density at seeding: 5E+8 cells/mL (in agar) and 5E+9 - 1E+10 cells/mL (suspension )
DURATION
- Exposure duration: 2 - 5 days
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: survival
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- Saccharomyces cerevisiae
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Executive summary:
A bacterial reverse mutation assay utilising Salmonella typhimurium and Saccharomyces cerevisiae was negative
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