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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Mutagenesis Testing of Acetyl-Tributylcitrate and Epoxidized Soybean Oil
Author:
Heath JL & Reilly M
Year:
1982
Bibliographic source:
Poultry Science 61, 2517 - 2519

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Name of test material (as cited in study report): Acetyl-tributylcitrate (CAS NR 77-90-7)
Analytical purity: No data

- Other: The test substance was extracted from plastic film for testing

Method

Species / strain
Species / strain / cell type:
other: S. typhimurium TA1535, TA1537, TA1538, TA98 and TA100
Metabolic activation:
without
Test concentrations with justification for top dose:
9 - 495 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Remarks:
only one group
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: Nitrofluorene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)
Statistics:
no data

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative without metabolic activation

ATBC gave no indication for mutagenic activity
Executive summary:

In 'Mutagenesis Testing of Acetyl-Tributylcitrate and Epoxidized Soybean Oil' [Poultry Science 61, Heath JL & Reilly M, 1982] it is reported that ATBC was tested in an Ames test similar to OECD Guideline 471 with limited information on test conditions.

The test substance gave no indication for mutagenic activity in S. typhimurium TA1535, TA1537, TA1538, TA98 and TA100 when tested without S9 mix. It can be assumed that the same applies to triethyl citrate (CAS 77-93-0) as it is a near analogue to the test substance acetyl tributyl citrate.