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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
yes
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Species / strain
Species / strain / cell type:
mouse lymphoma L5178Y cells
Additional strain / cell type characteristics:
other: TK +/-
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 3-methylcholanthrene (+S9) and ethyl methanesulfonate (-S9)
Statistics:
Not reported

Results and discussion

Test results
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid

Applicant's summary and conclusion

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

ATBC gave no indication for mutagenic activity.
Executive summary:

The Evaluation of Acetyl Tributyl Citrate in a Mouse Lymphoma Assay (L5178Y TK +/-) [1991; cited in US EPA (2003) High Production Volume (HPV) Chemicals Challenge Program: Assessment of Data Availability and Test Plan for Acetyl Tributyl Citrate (ATBC) (CAS NR 77-90-7)] has been carried out according to OECD Guideline 476. The test substance gave no indication for mutagenic activity (with and without metabolic activation). It can be assumed that the same applies to tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate (CAS 144 -15 -0) as it is a near analogue to the test substance acetyl tributyl citrate.