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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
publication
Title:
Genotoxicity and glucose tolerance induction by acetyltriethylcitrate, substitute plasticizer compared to di(2-ethylhexyl)phthalate
Author:
Jae-Wook Lee, Seok Jong Lee, Myung Chan Gye, Eun-Yi Moon
Year:
2019
Bibliographic source:
Sci Rep 9, 12237

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Remarks:
Data from Korea and not performed for REACH registration, GLP is not specified in the publication
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethyl O-acetylcitrate
EC Number:
201-066-5
EC Name:
Triethyl O-acetylcitrate
Cas Number:
77-89-4
Molecular formula:
C14H22O8
IUPAC Name:
triethyl 2-acetoxypropane-1,2,3-tricarboxylate
Details on test material:
Santa Cruz Biotechnology Inc, Dallas, TX, USA

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 metabolic activation:
Mutazyme S9 mix including NADPH cofactors was purchased from Molecular Toxicology, Inc. (MOLTOXTM, Boone, NC, USA) and stored below -20 °C until use. S9 mix was prepared from Sprague-Dawley rat liver induced with Aroclor 1254. For Ames test, 500 μL 5% S9 mix was used to mix 100 μl of each test substance solution, 100 μl of each bacterial suspension and 2 ml top agar.
Test concentrations with justification for top dose:
5, 2.5, 1.25, 0.625, and 0.3125 μl/plate (based on results from range finder, no details given)
Vehicle / solvent:
dimethyl sulfoxide (DMSO)
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
other: 2-Aminoanthracene, 2-(2-furyl)- 3-(5-nitro-2-furyl) acrylamide
Evaluation criteria:
When the results in experimental groups were at least twice higher than that in negative control, it was considered to be positive.
Statistics:
For Ames test, statistical analysis was not performed but individual plate counts, averages and standard deviations of revertant colonies are presented.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: S. typhimurium TA98, TA100, TA1535, TA1537 and E.coli WP2uvrA (pKM101)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
True negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The results indicate that ATEC did not exhibit a mutagenic potential in bacteria under our experimental conditions.
Executive summary:

Salmonella typhimurium (TA98, TA100, TA1535 and TA1537) or Escherichia coli (WP2uvrA (pKM101) was tested with and without metabolic activation S9 mix (according to OECD 471). At doses of 0.3125 up to 5 µl/plate no increase in bacterial revertants were observed. The positive controls were valid.