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EC number: 201-557-4 | CAS number: 84-74-2
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 455: "Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists", adopted 02. Oct. 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, 55116 Mainz, Germany)
- Type of assay:
- yeast cytogenetic assay
Test material
- Reference substance name:
- Dibutyl phthalate
- EC Number:
- 201-557-4
- EC Name:
- Dibutyl phthalate
- Cas Number:
- 84-74-2
- Molecular formula:
- C16H22O4
- IUPAC Name:
- dibutyl phthalate
- Test material form:
- other: oily liquid
- Details on test material:
- Purity > 99%
Homogeneity homogeneous
Stability stable at room temperature
Solubility soluble in DMSO
Production date not stated
Expiry date Nov. 2018
Storage room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Saccharomyces cerevisiae
- Additional strain / cell type characteristics:
- other: Mutations hERalpha and hAR receptor, expression plasmid carrying the reporter gene lacZ
- Test concentrations with justification for top dose:
- Dosage of Test Item
Eight concentrations with half-log dilutions were tested in duplicate. A stock solution containing 0.01 mol/L in DMSO was prepared for the serial dilution.
The following concentrations were tested: 3.16*10-8, 1.00*10-7, 3.16*10-7, 1.00*10-6, 3.16*106, 1.00*10:5, 3.16*10-5, 1.00*10-5, 3.16*10-5, 1.00*10-4 mol/1 - Vehicle / solvent:
- Dimethyl sulfoxide (DMSO) was used as a solvent for the test item and for the positive controls.
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- other: 17ß-estradiol (E2):
- Remarks:
- YES Agonist Assay
- Positive controls:
- yes
- Positive control substance:
- other: 4-hydroxytamoxifen (HT)
- Remarks:
- YES Antagonist Assay
- Positive controls:
- yes
- Positive control substance:
- other: 5alpha-dihydrotestosterone (DHT)
- Remarks:
- YAS Agonist Assay
- Positive controls:
- yes
- Positive control substance:
- other: Flutamide (FL)
- Remarks:
- YAS Antagonist Assay
- Details on test system and experimental conditions:
- Dimethyl sulfoxide (DMSO) was used as a solvent for the test item and for the positive controls.
Results and discussion
Test results
- Species / strain:
- Saccharomyces cerevisiae
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Positive and solvent controls showed the expected results.
After incubation with test item and yeast cells, no cytotoxicity was observed. The growth factor was within the expected range (> 0.5).
Dibutyl phthalate showed no endocrine activity, neither in the YES Assay nor in the YAS Assay: The values for galactosidase activity and induction ratio of all test item dilutions lay in the same range as the values of the respective control. No dose-response correlation was visible.
Under the conditions of this test system, the test item Dibutyl phthalate is considered to have neither estrogenic nor androgenic agonistic or antagonistic activity in the YES YAS Assay. - 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
After incubation with test item, no cytotoxicity was observed for the yeast cells.
The values for galactosidase activity and induction ratio of all test item dilutions lay in the same range as the values of the respective control. No dose—response correlation was visible. Dibutyl phthalate showed no endocrine activity, neither in the YES Assay nor in the YAS Assay.
Under the conditions of this test system, the test item Dibutyl phthalate is considered to have neither estrogenic nor androgenic agonistic or antagonistic activity in the YES YAS Assay.
The value for the positive controls were within the range of historical data of the test facility *
Some of the OD values of the solvent controls were not within the range of historical data of the test facility *. This is considered as uncritical for the following reason: The deviation from the respective range of the historical data was only marginal. Variation of biological systems within this order of magnitude is not unusual. For these reasons, the result ofthe test is considered as valid.
* See PDF 'Historical data' under 'Attached background material' above.
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