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EC number: 682-678-3 | CAS number: 182121-12-6
- 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:
- key study
- Study period:
- single dose application, 48 h incubation of yeast cells
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- comparable to OECD 455
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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 and hAR, reporter gene lac-Z for ß-galactosidase)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The YES/YAS assay uses genetically modified yeast cells, that can interact with the human estrogen and androgen receptors hERa and hAR. The reporter gene lac-Z, which encodes the enzyme ß-galactosidase is also integrated in the yeast cells.
If a test item interacts with the estrogen or androgen receptors, the reporter 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 product can be measured photometrically.
The measured OD (at 570 nm) values correlate directly with the amount of produced ß-galactosidase, which is an indication of the test item's activity towards the hERa or hAR receptors. - 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:
- 9,9-Bis(methoxymethyl)-9H-fluorene
- EC Number:
- 682-678-3
- Cas Number:
- 182121-12-6
- Molecular formula:
- C17H18O2
- IUPAC Name:
- 9,9-Bis(methoxymethyl)-9H-fluorene
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- 9,9-Bis(methoxymethyl)-9H-fluorenone, CAS No. 682-678-3, monoconstituent substance, homogeneous, solid, stable at room temperature
batch no. Mel-Sab-01, expiry date Dec. 2018, purity: >99%
Test animals
- Species:
- other: yeast (Saccharomyces cerevisiae), genetically modified
- Strain:
- other: yeast (Saccharomyces cerevisiae), genetically modified
- Remarks:
- hERa and hAR receptor, expression plasmid carrying the reporter gene lacZ
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- The YES-YAS Assay Kit including Saccharomyces cerevisiae was obtained from Xenometrix AG, Gewerbestraße 25, CH-4123 Allschwil, Switzerland
batch No:: N05-12477
4 days before the start of the experiment, the yeast cultures were prepared in 2 different culture flasks (for YES and YAS assays respectively) and incubated at 32 +/- 1°C for 71h (YAS culture) or 95.5 h (YES culture) until the cultures were clearly turbid. Then the optical density at 690 nm for the growth of the yeast cells was measured with a microplate reader. The cultures were diluted appropriately and used for the experiment.
Administration / exposure
- Route of administration:
- other: dropped into culture cultureflasks
- Vehicle:
- DMSO
- Details on exposure:
- After checking the yeast cultures for growth with a microplate reader by measuring the optical density, 7 dilutions of positive controls and 8 dilutions of test item were pipetted into a 96-well dilution plate.
Next, 4 assay plates were labelled (YES Agonist/ YAS Agonist/ YES Antagonist/ YAS Antagonist) and filled with the corresponding assay 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 the yeast cells the plates were incubated at 32 +/- 1°C in a humidity container with agitation. Colour change of the medium in the positive control wells indicated growth after 46 h.
Then, the well plates were measured with a microplate reader at 690 nm for cell growth and at 570 nm for colour development.
Evaluation was done with Microsoft Excel. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- microplate reader at 690 nm for cell growth and at 570 nm for colour development of positive controls and test item.
- Duration of treatment / exposure:
- 46 h (indication by colour change of the positive controls)
- Frequency of treatment:
- single dose application
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: mol/L
- Remarks:
- 8 concentrations with half-log concentrations, up to 0.0001 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:
- 8 dilutions of positive controls or test item were examined in duplicate.
YES or YAS agonistic activity was detected directly by ß-galctosidase activity. Antagonistic activities were detected by inhibition of ß-galactosidase activities in the presence of estrogenic or androgenic substances.
The solvent DMSO served as negative control. Cytotoxicity was checked by measurement of the cell density.
Examinations
- Examinations:
- Colour change by ß-galactosidasse activity
The ß-galactosidase activity correlates directly with the activating (agonist) or inhibiting (antagonist) activity 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:
- The experiment was valid. 8 dilutions of the test item in DMSO and controls (solvent control and positive controls) were exposed to the modified yeast cells in duplicate. After incubation positive and solvent (negative) controls showed the expected results. No cytotoxicity was observed (controlled by measurement of the cell density). The test item showed no positive result in any assay. The values of ß-galactosidase activity and induction ratio of all test item dilutions lay in the same range as the values of the respective controls. No dose-response correlation was visible.
Therefore the test item is considered to have no estrogenic and androgenic agonistic and antagonistic activity under the conditions of this experiment.
Applicant's summary and conclusion
- Conclusions:
- The test item is considered to show no estrogenic or androgenic agonistic or antagonistic activities in the YES/YAS assay.
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