Registration Dossier
Registration Dossier
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EC number: 205-617-0 | CAS number: 144-15-0
Genetic toxicity: in vitro
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:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- Tributyl O-acetylcitrate
- EC Number:
- 201-067-0
- EC Name:
- Tributyl O-acetylcitrate
- Cas Number:
- 77-90-7
- IUPAC Name:
- tributyl 2-acetoxypropane-1,2,3-tricarboxylate
- Test material form:
- not specified
Constituent 1
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.
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