Registration Dossier
Registration Dossier
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EC number: 218-528-7 | CAS number: 2173-56-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- Determination of the mutagenic potential of Pentyl valerate with the "In Vitro Mammalian Chromosomal Aberraton Test" following OECD 473 and EU B.10
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28. Apr. 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- uncritical
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Landesamt für Umwelt, Wasserwirtschft und Gewerbeaufsicht, Kaiser-Friedrich-Str. 7, D-55116 Mainz, Germany
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Pentyl valerate
- EC Number:
- 218-528-7
- EC Name:
- Pentyl valerate
- Cas Number:
- 2173-56-0
- Molecular formula:
- C10H20O2
- IUPAC Name:
- pentyl valerate
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- chromosomal aberration
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Details on mammalian cell type (if applicable):
- Donors: Young, adult, healthy humans
- Additional strain / cell type characteristics:
- other: the blood of one donor revealed a fragile site at chromosome 16 (fra(16)(q?22)). This was not included in the assessment of mutagenicity
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- pre-experiment (cytotoxicity test):1.72/0.86/0.43/0.22/0.11 mg/ml (concentrations in the experiment)
experiment 1 (cytotoxicity test): without metabolic activation: 125/100/75/50/25/13 µg/ml, with metabolic activation: 1.72/0.86/0.43/0.22/0.11 mg/ml
experiment 2 (aberration assay): without metabolic activation: 100/50/13 µg/ml - Vehicle / solvent:
- ethanol
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Remarks:
- ethyl methanesulphonate (experiment without metabolic activation), cyclophosphamide (experiment with metabolic activation)
- Details on test system and experimental conditions:
- Human peripheral blood lymphocytes were stimulated to divide by addition of phytohaemagglutinin and exposed to the test substance with and without metabolic activation by S9-Mix. Metaphase cells were obtained by arresting cell divison by Colcemid (R) and slides were prepared. Then these metaphase cells were examined for chromosomal damage visually by the Zeiss microscopes and the automatic slide scanning system Metafer by MetaSystems. The mitotic index was calculated. 3 valid experiments were performed: Pre-experiment (4h exposure, without metabolic activation), experiment 1 (4h, exposure, with and without metabolic activation), experiment 2 (25h exposure, without metabolic activation). 3 tests were invalid.(too high cytotoxicity, solvent control positive, no results obtained).
- Rationale for test conditions:
- This study was performed in order to evaluate the mutagenic potential of the test substance according to OECD 473
- Evaluation criteria:
- Acceptability: Controls are within the range of historical control data, no positive (mutagenic) result ist found in any experiment, an adequate number of cells is analysable, criteria for cell proliferation is fulfilled.
Classification: No significant or concentration-released chromosomal aberration is found: The test substance is not mutagenic - Statistics:
- 300 metaphases (150 per replicate) were scored for cytogenetic damage. The number of aberrant cells in each treatment was compared with the solvent control value using Fisher's exact test or chi-sqaure-test atn the 5% level (p<0.05).
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: high cytotoxicity, but no mutagenic potential found in this experiment
Applicant's summary and conclusion
- Conclusions:
- Test item showed high cytotoxicity, but no mutagenic potential found in this experiment
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