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EC number: 204-260-8 | CAS number: 118-56-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Androgen receptor binding potential assay
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Neither guideline test nor obey with GLP, but fulfill with basically scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Reference Type:
- publication
- Title:
- A rapid, specific protocol for determination of available androgen receptor sites in unfractioned rat ventral prostate cytosol preparations
- Author:
- Boesel RW, Shain SA
- Year:
- 1 974
- Bibliographic source:
- Biochem. Biophys. Res. Comm. 61: 1004-1011.
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The principles of this method is using a rat recombinant fusion protein containing both hinge region and ligand binding domain of the AR as receptor source and radiolabeled methyltrienolone as ligand. Then the test substance was added to the system, which aimed to investigate the affinity of the test substance for the AR by comparing the replacement potential of test substance for "radiolabeled methyltrienolone" with the potential of the reference compounds of dihydrotestosterone and androstenedione.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Homosalate
- EC Number:
- 204-260-8
- EC Name:
- Homosalate
- Cas Number:
- 118-56-9
- Molecular formula:
- C16H22O3
- IUPAC Name:
- 3,3,5-trimethylcyclohexyl salicylate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- In vitro method with a rat recombinant fusion protein containing both the hinge region and ligand binding domain of the AR as receptor source and methyltrienolone as ligand.
Administration / exposure
- Route of administration:
- other: not relevant for in vitro method
- Vehicle:
- DMSO
- Remarks:
- 2 %
- Details on exposure:
- 100 μL assay buffer [50 mM Tris-HCl pH 7.5, 0.8 M sodium chloride, 2 mM DTT, 10% glycerol (V/V)] containing γ-globulin (20 mg/mL) and 2% DMSO (with and without test substance), 50 μL of an 8 nM solution of radiolabeled R1881 in assay buffer containing 1.1% ethanol and 50 μL of an 8 nM AR solution in assay buffer were fully mixed in microtitre plate wells. Final concentrations were 10 mg/mL γ-globulin, 2 nM R1881 and 2 nM AR. Following incubation at 4 ℃ overnight under continuous shaking, 50 μL of a 5 % charcoal suspension in assay buffer was added. After samples mixed at 4 ℃ for 10 min, charcoal was sedimented by centrifugation at 4000 rpm for 5 min. Then 50 μL aliquots of the clear supernatant were analyzed by liquid scintillation counting.
- Details on mating procedure:
- not applicable
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- not applicable
- Duration of treatment / exposure:
- 10 min
- Frequency of treatment:
- Not applicable
- Details on study schedule:
- not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10 nM to 100000 nM
Basis:
other: Nominal in assay buffer
- No. of animals per sex per dose:
- Not applicable
- Control animals:
- other: six fold incubations of vehicle (DMSO) alone
- Details on study design:
- 3H activity as a measure of ligand concentrations was determined by liquid scintillation counting (LSC). Aliquots (50 μl) of assay buffer were taken at least in triplicate and were mixed with 5 mL scintillation cocktail (Ultima Gold). Samples were counted for 5 minutes. Decays per minute were calculated from counts per minutes using a calibration curve established and regularly checked by a set of differentially quenched 3H standards.
Aliquots (50 μL) containing the AR-ligand complex were mixed with 200 μL Ultima Flo AP scintillation cocktail and radioactivity was counted for 10 min in the LSC microplate reader with one hour delay allowing samples to equilibrate. - Positive control:
- Dihydrotestosterone (Strong binding reference) and androstenedione (Weak binding reference) in the range of 0.1 nM to 300 nM and 30 nM to 100000 nM, respectively.
Examinations
- Parental animals: Observations and examinations:
- Not relevant
- Oestrous cyclicity (parental animals):
- Not relevant
- Sperm parameters (parental animals):
- Not relevant
- Litter observations:
- Not relevant
- Postmortem examinations (parental animals):
- Not relevant
- Postmortem examinations (offspring):
- Not relevant
- Statistics:
- Samples were counted for 5 minutes. Decays per minute were calculated from counts per minutes using a calibration curve established and regularly checked by a set of differentially quenched 3H standards.
- Reproductive indices:
- Not relevant
- Offspring viability indices:
- Not relevant
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Description (incidence and severity):
- not applicable
- Body weight and weight changes:
- not specified
- Description (incidence and severity):
- not applicable
- Food consumption and compound intake (if feeding study):
- not specified
- Description (incidence and severity):
- not applicable
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Description (incidence and severity):
- not applicable
- Other effects:
- not specified
- Description (incidence and severity):
- Test substance intake: not applicable
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Description (incidence and severity):
- not applicable
- Reproductive function: sperm measures:
- not specified
- Description (incidence and severity):
- not applicable
- Reproductive performance:
- not specified
- Description (incidence and severity):
- not applicable
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- other: in vitro binding to the androgen receptor
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified Generation not specified (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Description (incidence and severity):
- not applicable
- Mortality / viability:
- not specified
- Description (incidence and severity):
- not applicable
- Body weight and weight changes:
- not specified
- Description (incidence and severity):
- not applicable
- Sexual maturation:
- not specified
- Description (incidence and severity):
- not applicable
- Organ weight findings including organ / body weight ratios:
- not specified
- Description (incidence and severity):
- not applicable
- Gross pathological findings:
- not specified
- Description (incidence and severity):
- not applicable
- Histopathological findings:
- not specified
- Description (incidence and severity):
- not applicable
Details on results (F1)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The results from the test shows the test substance can moderately displace the radiolabeled ligand methyltrienolone from the androgen receptor (AR) in a concentration dependent manner. However, this displacement was weak, occurred only at high concentrations. The concentration-response relationship - especially at higher concentrations was flat, and a corresponding IC50 -value can not be established. In contrast, the reference substances dihydrotestosterone (DHT) and androstenedione (ANDRO) can displace the radiolabeled ligand methltrienolone from the AR with a significantly steep concentration - response relationship. The concentration-response curve obtained for the test substance was not paralleled with DHT and ANDRO thus suggesting an unspecific interaction with AR binding.
Applicant's summary and conclusion
- Conclusions:
- The test substance inhibited to some extent the binding of the test ligand methyltrienolone to the androgen receptor, but even at the highest tested concentration of 0.1 mM did not achieve 50% inhibition; from this and the shallow dose-response curve compared to the other ligands dihydrotestosterone and androstendione, it was concluded that homosalate did not bind to the hormone binding site on the androgen receptor.
- Executive summary:
Potential of interaction of the registration substance with the androgen receptor (AR) was investigated by means of a classical receptor binding assay using a rat recombinant fusion protein containing both hinge region and ligand binding domain of AR as receptor source and radiolableled methyltrienolone as ligand.
The test substance weakly displaced the radiolabeled ligand methyltrienolone from the AR in a concentration - dependent manner. However, displacement at the maximum concentration of 100 mM can not exceed 32% and 41%, respectively, in two separated tests and accordingly IC50 can not be obtained. In addition, the concentration - response curve was flat and did not parallel those observed for DHT and ANDRO. Thus, it can be concluded that the test substance can not generate the androgen binding concern.
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.
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