Registration Dossier
Registration Dossier
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EC number: 201-070-7 | CAS number: 77-93-0
Genetic toxicity: in vitro
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:
- 1 982
- Bibliographic source:
- Poultry Science 61, 2517 - 2519
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse 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
- Molecular formula:
- C20H34O8
- IUPAC Name:
- tributyl 2-acetoxypropane-1,2,3-tricarboxylate
- 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
Constituent 1
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.
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