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EC number: 807-124-1 | CAS number: 1519029-23-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Specific investigations: other studies
Administrative data
- Endpoint:
- endocrine system modulation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- single dose application, 46.5 h exposure time
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 455
- Version / remarks:
- The YES/YAS assay works with genetically modified yeast cells (human estrogen and androgen receptors hERa nd hAR, reporter gene lac-Z for ß-galactosidase on plasmid)
- Deviations:
- not applicable
- Remarks:
- 1. experiment invalid due to calculation error
- Principles of method if other than guideline:
- The YES/YAS assay uses genetically modified yeast cells, which contain the human estrone and androgen receptors hERa and hAR. The receptor gene lac-Z, which encodes enzyme ß-galactosidas is also integrated in the cells.
If a test item interacts with a receptor, the reporte gene will be expressed and ß-galactosidase will be secreted into the medium. The medium contains an indicator (CPRG), which is converted by ß-galactosidase into a red product. This red product can be measured photometrically. - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht Rheinland-Pfalz, Kaiser-Friedrich-Str. 7, D-55116 Mainz, Germany
- Type of method:
- in vitro
Test material
- Reference substance name:
- 4-(methylamino)pentane-2-ol dibenzoate
- EC Number:
- 807-124-1
- Cas Number:
- 1519029-23-2
- Molecular formula:
- C20H23NO3
- IUPAC Name:
- 4-(methylamino)pentane-2-ol dibenzoate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- 4-(methylamino)pentan-2-ol dibenzoate, CAS No.: 15 19029-23-2, monoconstituent, solid, homogenous, stable at room temperature, soluble in DMSO
batch no. STCB/226/14, production date: Jun. 2014, purity: 96.06%
Test animals
- Species:
- other: yeast (Saccharomyces cerevisiae), genetically modified
- Strain:
- other: yeast, genetically modified: hERa and hAR receptors, plasmid containing lac-Z
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- The YES/YAS Assay Kit was including Saccharomyces cerevisiae was obtained from Xenometrix AG, Gewerbestraße 25, CH-4123 Allschwil, Switzerland
batch no: N05-2785 (invalid experiment) and N05-2862 (valid experiment)
Administration / exposure
- Route of administration:
- other: dropped into culture flasks
- Vehicle:
- DMSO
- Details on exposure:
- After checking the yeast cultures for growth witha icroplate reader by measuring the optical density, 8 dilutions of positive controls and test item dilution respectively were pipetted into a 96-well dilution plate.
Next 4 assay plates were labelled (YES agonist/YAS agibost/YES antagonist/YAS antagonist) and filled with the corresponding medium. Then each positive control dilution and test item dilution was pipetted from the dilution plate to an assay plate in duplicate. After addition of yeast cells the plates were incubated at 32 +/-°C in a humidity container with agitation. Colour change of the medium in the positive controls indicated reaction after 46.5h. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Yeast cells were checked for growth by measuring of the optical density at 690 nm.
- Duration of treatment / exposure:
- 46.5 h
- Frequency of treatment:
- single dose
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: mol/L
- Dose / conc.:
- 0 other: mol/L
- Dose / conc.:
- 0 other: mol/L
- Dose / conc.:
- 0 other: mol/L
- Dose / conc.:
- 0 other: mol/L
- Dose / conc.:
- 0 other: mol/L
- Dose / conc.:
- 0 other: mol/L
- Dose / conc.:
- 0 other: mol/L
- Details on study design:
- Two experiments were performed. The first experiment was invalid, because the concentration of the stock solution of the test item was too low. Therefore the experiment was repeated. The second experiment was valid.
8 dilutions of positive controls or test item were examined in duplicate. Estrogen and androgen agonistic activities were detected directly by ß-galactodsidase activity. Antagonistic activities were detected by inhibition of ß-galactosidase activity in the presence of estrogen or androgen.
The solvent DMSO served as negative control. Cytotoxicity was checked be measurement of the cell density.
Examinations
- Examinations:
- Colour change by ß-galctosidase activity.
The ß-galactosidase activity correlates directly with the activating (agonists) or inhibiting (antagonists) activities of the test item. - Positive control:
- YES agonist assay: 17ß-estradiol (E2)
YES antagonist assay: 4-hydroxytamoxifen (HT)
YAS agonist assay: 5a-dihyrotestosterone (DHT)
YAS antagonist assay: Flutamide (FL)
Results and discussion
- Details on results:
- Under the conditions of this test the test item 4-(methylamino)pentan-2-ol dibenzoate showed no estrogenic and androgenic agonistic or antagonistic properties.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this YES/YAS assay no estrogenic or androgenic agonistic or antagonistic activities for the test item 4-(methylamino)pentane-2-ol dibenzoate were found.
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