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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
2001
Bibliographic source:
US Federal Register Vol. 66, No. 4, pages 1129-1135
Reference Type:
study report
Title:
Unnamed
Year:
1976
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

Constituent 1
Chemical structure
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

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