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EC number: 405-520-5 | CAS number: 95235-30-6 D-8; DD-8
- 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
Endocrine disrupter mammalian screening – in vivo (level 3)
Administrative data
- Endpoint:
- endocrine disrupter mammalian screening – in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-12-01 to 1998-03-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 440 (Uterotrophic Bioassay in Rodents: A Short-term Screening Test for Oestrogenic Properties)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 4-(4-isopropoxyphenylsulfonyl)phenol
- EC Number:
- 405-520-5
- EC Name:
- 4-(4-isopropoxyphenylsulfonyl)phenol
- Cas Number:
- 95235-30-6
- Molecular formula:
- C15H16SO4
- IUPAC Name:
- 4-[4-(propan-2-yloxy)benzenesulfonyl]phenol
- Details on test material:
- - Name of test material (as cited in study report): D - 8
- Molecular formula: C15 H16 O4 S;
- Molecular weight: 292.4;
- Physical state: solid;
- Analytical purity: 99.94 %;
- Purity test date: not stated;
- Lot/batch No.: ME-685;
- Expiration date of the lot/batch: not stated;
- Stability under test conditions: stable at ambient temperature and conditions;
- Storage condition of test material: store in a cool dry place, protected from direct sunlight;
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- State:
- ovariectomized female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Age at study initiation: 4 - 5 weeks
- Weight at study initiation: 123 - 149 g
- Fasting period before study: No
- Housing: 5 animals per cage in polypropylene cages with grid floors
- Diet: standard certified laboratory rodent diet (RM1(ESQC) ad libitum
- Water: tap water ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 3 °C
- Humidity: 50 +/- 15 % R.H.
- Air changes (per hr): not indicated
- Photoperiod : 12 hrs light /12 hrs dark from 07:00 a.m. to 07:00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test formulations were prepared on the days of dosing.
Test articles were formulated in 0.5 % (w/v) carboxymethylcellulose (CMC) at the highest concentration.
Lower concentrations were obtained by serial dilution of the highest concnetration using 0.5 % (w/v) CMC.
Test articles were administered as a single oral dose over a period of 4 days, using a constant dose volume of 10 mL/kg. Oestradiol benzoate was administered by a single subcutaneous injection under the loose skin at the back of the neck over a period of 4 days, using a constant dose volume of 5 mL/kg.
VEHICLE
- Concentration in vehicle: 100 mg/mL, 10 mg/mL
- Amount of vehicle: 10 mL/kg - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 4 days
- Frequency of treatment:
- Once per day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Study with young adult females after ovariectomy:
yes
- Age at ovariectomy and duration of acclimatization after ovariectomy: 5-6 weeks; 10 days - Positive control:
- Oestradiol benzoate, 10 µg/kg, sc.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Not specified
DETAILED CLINICAL OBSERVATIONS: Not specified
BODY WEIGHT: Yes
- Time schedule for examinations: Twenty-four hours after the final dose
SPECIFIC ENDPOINTS
- Wet uterine weight: Yes
- Time schedule: Twenty-four hours after the final dose the animals were sacrificed by CO2 asphyxiation followed by cervical dislocation and the uteri removed. The uterine contents were gently squeezed out and the uteri weighed. - Sacrifice and pathology:
- GROSS PATHOLOGY: No
HISTOPATHOLOGY: No - Statistics:
- A comparison of the uterine weights of the test article-treated and vehicle treated control animals was made using analysis of covariance using initial body weights as covariate. (Shirley, 1977, The analysis of organ weight data, Toxicology, 8, 13-22).
After conversion of the uterine weight data into percentage of total body weight, similar comparision were made using analysis of variance.
Results and discussion
- Endocrine disrupting potential:
- negative
- Maximum tolerated dose level exceeded:
- no
Results of examinations
- Clinical signs:
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Clinical biochemistry findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No marked or statistically significant increases in uterine weight was observed when compared with vehicle-treated control animals.
- Gross pathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Details on results:
- Oral administration of the test item to rats in doses of 100 and 1000 mg/kg for 4 days produced no marked or statistically significant increases in uterine weight when compared with vehicle-treated control animals.
As expected, the reference standard oestradiol benzoate administered subcutaneously at 10 µg/kg/day for 4 days produced marked and statistically significant increases in uterine weight when compared with the relevant vehicle-treated control group.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- organ weights
Any other information on results incl. tables
Table 1: Assessment of the effects of the test item on oestrogenic activity in the rat on uterine weight
Group |
Treatment |
Route |
Dose (mg/kg) |
Group mean uterus weight (mg±sd) |
% increase in the mean uterus weight from relevant vehicle group |
1 |
Vehicle (0.5 % CMC) |
po |
- |
45.4± 4.2 |
- |
2 |
D-8 |
po |
100 |
52.8 ± 42.6 |
16.3 |
3 |
D-8 |
po |
1000 |
41.2 ± 5.3 |
-9.25 |
4 |
Vehicle (arachis oil) |
sc |
- |
39.8 ± 25.0 |
- |
5 |
Oestradiol benzoate |
sc |
10 µg/kg |
158.2 ± 11.8 ** |
297.49 |
sd: Standard deviation
Statistical significance of difference compared to Group 4 using analysis of covariance: ** p< 0.01
Table 2: Assessment of the effects of the test item on oestrogenic activity in the rat on uterine weight as a % of bodyweight
Group |
Treatment |
Route |
Dose (mg/kg) |
Group mean uterus weight as a % of bodyweight (±sd) |
% increase in the mean uterus weight from relevant vehicle group |
1 |
Vehicle (0.5 % CMC) |
po |
- |
0.028± 0.004 |
- |
2 |
D-8 |
po |
100 |
0.035 ± 0031 |
25.00 |
3 |
D-8 |
po |
1000 |
0.026 ± 0.003 |
-7.14 |
4 |
Vehicle (arachis oil) |
sc |
- |
0.025 ± 0.017 |
- |
5 |
Oestradiol benzoate |
sc |
10 µg/kg |
0.104 ± 0.006 ** |
316.00 |
sd: Standard deviation
Statistical significance of difference compared to Group 4 using analysis of variance: ** p< 0.01
Applicant's summary and conclusion
- Conclusions:
- The test item produced no notable estrogenic effects in this test as determined by increases in rat uterine weight.
- Executive summary:
The test item was administered as an oral dose to female Wistar rats over a period of 4 days at a dose of 100 mg/kg or 1000 mg/kg bw in order to assess the possible oestrogenic effects as determined by increases in uterine weight. The test item administered orally to rats at 100 and 1000 mg/kg bw for 4 days produced no marked or statistically significant increases in uterine weight when compared with control animals dosed with vehicle (0.5% w/v carboxymethylcellulose, (CMC)). As expected, the reference standard oestradiol benzoate administered subcutaneously at 10 µg/kg/day for 4 days produced marked and statistically significant increases in uterine weight when compared with the relevant vehicle-treated control group.
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