Registration Dossier
Registration Dossier
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EC number: 245-122-7 | CAS number: 22613-51-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970s-1980s
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-acetoxyethyl stearate
- EC Number:
- 245-122-7
- EC Name:
- 2-acetoxyethyl stearate
- Cas Number:
- 22613-51-0
- Molecular formula:
- C22H42O4
- IUPAC Name:
- 2-acetoxyethyl stearate
- Test material form:
- solid: flakes
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97, 98, 100, 102
- Metabolic activation:
- with
- Metabolic activation system:
- S9-mix from liver of Aroclor 1254 treated male rats
- Test concentrations with justification for top dose:
- 0, 312, 625, 1250, 2500, 5000 ug/plate
- Vehicle / solvent:
- PBS (pH 7.4) with Sorbitan 80 OE monoleate and 20 OE monolaurate
Controlsopen allclose all
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Daunomycin
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Details on test system and experimental conditions:
- 48h exposure in three replicas
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA97, 98, 100, 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
Applicant's summary and conclusion
- Conclusions:
- AGS was not toxic for the four tester strains up to 5000 ug/plate.
No substantial increase in the number of revertant colonies was observed in any of the four tester strain after exposure to AGS concentration ranging fron 312 to 5000 ug/plate.
AGS is not mutagenic in this bacterial test system at the dose levels used.
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