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EC number: 201-250-5 | CAS number: 80-09-1
- 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:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: incomplete reporting (e.g. with respect to absolute bw and uterus weight data, statistical analysis)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Relationship between the results of in vitro receptor binding assay to human estrogen receptor a and in vivo uterotrophic assay: Comparative study with 65 selected chemicals.
- Author:
- Akahori Y. et al.
- Year:
- 2 008
- Bibliographic source:
- Toxicology in Vitro 22, 225–231
- Reference Type:
- publication
- Title:
- Comparative study of the uterotrophic potency of 14 chemicals in a uterotrophic assay and their receptor-binding affinity
- Author:
- Yamasaki K. et al.
- Year:
- 2 004
- Bibliographic source:
- Toxicology Letters 146, 111–120
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Draft guideline OECD440 Uterotrophic Bioassay in Rodents: A short-term screening test for estrogenic properties
- Principles of method if other than guideline:
- Immature rat uterotrophic assay as estrogenic and anti-estrogenic system.
The test chemical was evaluated as estrogenic or anti-estrogenic if the uterine weights were significantly increased in the estrogenic assay or decreased in the antiestrogenic assay.
The log of the lowest effective doses (logLED, µmol/kg/day) were identified. - GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- 4,4'-sulphonyldiphenol
- EC Number:
- 201-250-5
- EC Name:
- 4,4'-sulphonyldiphenol
- Cas Number:
- 80-09-1
- Molecular formula:
- C12H10O4S
- IUPAC Name:
- 4,4'-sulfonyldiphenol
- Details on test material:
- 4,4´-Sulfonyldiphenol, Supplier: TCI (Tokyo Kasei Kogyo Co.)
Purity > 99.4%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan Inc. (Shiga, Japan)
- Age at study initiation: rat pups (10-day old)
- Housing: individual, in polycarbonate pens until weaning, following 19 days weaning in stainless steel wire-mesh cages throughout
the study.
- Diet (e.g. ad libitum): commercial diet (CRF-1, Oriental Yeast Co., Tokyo, Japan)
- Water (e.g. ad libitum): yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/-2°C
- Humidity (%): 55 +/-5%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- olive oil
- Details on exposure:
- Female rat pups (10-day old) were weaned with their dams and individually housed until 19-days old.
These immature female rats were weighted and weight-ranked to assign to each of the treated and control groups (6 rats/group).
Three doses were used and the highest dose was set at the maximum tolerance dose based on the results of dose-range finding test.
Subcutaneous injections were applied into the back for three consecutive days (4 mL/kg/day).
At the day of first injection the animals were 20 days old.
Vehicle control group:olive oil (s.c.) - Frequency of treatment:
- 3x on 3 consecutive days
- No. of animals per sex per dose:
- 6 females
Examinations
- Examinations:
- Body weight and clinical signs were recorded daily.
The animals were sacrificed by bleeding from the abdominal vein under deep ether anesthesia 24 h after the final administration, and body weight and uterine weight of each animal were recorded. - Positive control:
- Positive control group estrogenic activity:
0.6 µg/kg/day 17alpha-ethynylestradiol (s.c.) after administration of the chemicals at the same doses.
A vehicle control group was injected with olive oil alone.
A group injected with the estrogen-antagonist chemical tamoxifen in a dose of 1 mg/kg per day plus EE was also established to confirm the reliability of this study.
Results and discussion
- Details on results:
- Of 65 chemicals evaluated in this study 31 and 25 chemicals were identified as estrogenic and anti-estrogenic in immature rat uterotrophic assay, respectively. 29 exhibited both estrogenic and anti-estrogenic responses.
logLED estrogenic 4,4´-sulphonyldiphenol: 1.9 µmol/kg/day
logLED anti-estrogenic 4,4´-sulphonyldiphenol: 3.3 µmol/kg/day
logLED estrogenic 17beta-estradiol: <-2.43 µmol/kg/day (as determined in independent study from 23-days old rats, Padilla-Banks et al. 2001)
logLED anti-estrogenic 17beta-estradiol: N.A.
The lowest logLED was itentified with the positive control (17beta-estradiol: <-2.43 µmol/kg/day) highest with 4-tert-Butylcatechol (3.78).
Any other information on results incl. tables
Table: body and uterine weights [mg]/[mg/100g]
weights |
body |
Relative uterine wet |
Relative uterine blotted |
Vehicle control |
58.3 +/-3.4 |
64 +/-9.3 |
63 +/-9.4 |
20 |
59.7 +/-3.8 |
81.6 +/-13.3* |
80.7 +/-12.8* |
100 |
57.6 +/-1.9 |
73.8 +/-8.5 |
72.6 +/-8.3 |
500 |
58 +/-2.8 |
107.5 +/-25** |
105.6 +/-23.8** |
Vehicle +EE |
60.6 +/-2.3 |
245.3 +/-13.8 |
193.8 +/-13.2 |
20 +EE |
58.9 +/-4 |
307.5 +/-38.8°° |
218.4 +/-10.6°° |
100 +EE |
59 +/-2.8 |
257 +/-73.7 |
201.4 +/-21.2 |
500 +EE |
58.2 +/-3.8 |
137.7 +/-20.8°° |
135.4 +/-20.3°° |
TMX +EE |
57.5 +/-3.6 |
158.5 +/-15.2°° |
156.6 +/-15°° |
*significantly different from vehicle control at p<0.05
**significantly different from vehicle control at p<0.01
°°significantly different from vehicle control plus EE at p<0.01
The uterine weight of the rats given EE was higher than that of the rats given vehicle alone, and the uterine weight of the rats given tamoxifen plus EE was lower than that of the rats given EE, confirming the reliability of this study.
Uterine weight was significantly higher in the 20 (p<0.05) and 500 mg/kg (p<0.01) groups.
Uterine weight was significantly lower in the 500 mg/kg plus EE group (p<0.01) and, by contrast, significantly higher in the 20 mg/kg plus EE group (p<0.01).
Applicant's summary and conclusion
- Conclusions:
- The very low relative binding affinity observed with 4,4´-sulfonyldiphenol in an in vitro receptor binding assay (logRBA -2.26, Akaori et al. 2008) well correlated to the high dose required to observe a statistically significant effect in the uterotrophic assay (logLED 1.9), as compared to the internal positive control 17beta-estradiol, respectively.
This in vivo screening assay is included in the third of five levels of an OECD conceptual framework for testing and assessment of potential endocrine disrupting chemicals. This assay may provide data about a single endocrine mechanism, i.e. oestrogenicity.
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