Registration Dossier
Registration Dossier
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EC number: 479-950-7 | CAS number: 31274-51-8
Specific investigations: other studies
Administrative data
- Endpoint:
- endocrine system modulation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically valid GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The ER competitive binding assay:
The assay conducted is based upon that described by Shelby et al (1996), but using the uteri of immature rats as a source of cytosolic ER. Immature animals are used, ensuring that most of the ER is free to bind the radioactive estradiol used in the assay. - GLP compliance:
- yes
- Type of method:
- in vitro
- Endpoint addressed:
- other: hormone receptor binding
Test material
- Test material form:
- solid: bulk
- Details on test material:
- Please refer to "Confidental details on test material".
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- Please refer to "Further details on study design"
Administration / exposure
- Details on exposure:
- Please refer to "Further details on study design"
- Details on study design:
- The study consisted of harvesting the uteri from 40 immature Alderley Park rats. Freshly prepared cytosolic preparations of uterine tissue were then incubated with the test substance at a range of concentrations (0.5 nM to 0.5 mM) and a fixed concentration (5 nM) of the radiolabelled estrogen, 3H-estradiol in order to determine the ability of the test item to displace the 3H-estradiol.
Quantitation of displacement was used to determine the intrinsic activity of the test item to interact with the estrogen receptor (ER).
Two independent assays with duplicates in each assay were performed.
Results and discussion
- Details on results:
- FAT 65’080/B exhibited no displacement of 3H-estradiol at any of the concentrations tested. Displacement of 3H-estradiol was observed following incubation with increasing concentrations of non-radioactive estradiol (positive control) but not with DMSO (vehicle control).
Consistent results were obtained between duplicates within each assay and across both assays.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
