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Diss Factsheets
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EC number: 701-171-0 | CAS number: -
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1960 - June 1961
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with US FDA standard methods with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 961
- Report date:
- 1961
Materials and methods
- Principles of method if other than guideline:
- Procedures following the principles described in the US Food and Drug Administration's publication entitled "Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics"
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Phenol, styrenated
- EC Number:
- 262-975-0
- EC Name:
- Phenol, styrenated
- Cas Number:
- 61788-44-1
- IUPAC Name:
- 2,4-divinylphenol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Food and Drug Research Laboratories inbred colony
- Age at study initiation: no data
- Weight at study initiation: 60 - 100 g
- Fasting period before study: no data
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: not applicable
DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): basal diet (Purina Laboratory Chow supplemented with vitamins)
- Storage temperature of food: no data
VEHICLE
Not applicable - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Dietary administration, ad libitum
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100, 316, 1000, 3160, 10000 ppm
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
4, 12.6, 40, 126.4, 400 mg/kg (males)
Basis:
other: converted from nominal concentrations using standard food intake values
- Remarks:
- Doses / Concentrations:
5, 15.8, 50, 158, 500 mg/kg (females)
Basis:
other: converted from nominal concentrations using standard food intake values
- No. of animals per sex per dose:
- - 30 rats/sex/treated group
- 60 rats/sex for controls - Control animals:
- yes, plain diet
- Details on study design:
- No data
- Positive control:
- Not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations were not included.
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: weekly (for the first 12 weeks)
FOOD CONSUMPTION AND COMPOUND INTAKE (feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes (over 12 weeks)
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No (efficiency of food calculation calculated as g body weight gain per 100 g of food eaten per sex and per group over 12 weeks)
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at 12 weeks
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 5 males + 5 females per dose group
- Parameters examined: hemoglobin, hematocrit, erythocyte count, coagulation and prothrombin times, total and differential leukocyte counts
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at 12 weeks
- Animals fasted: No data
- How many animals: 5 males + 5 females per dose group
- Parameters examined: blood glucose, urea nitrogen, cholesterol concentrations + liver cholesterol concentration
URINALYSIS: Yes
- Time schedule for collection of urine: at 12 weeks
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: not specified
NEUROBEHAVIOURAL EXAMINATION: No data
OTHER: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (10 control males + 10 control females, 5 males + 5 females per dose group)
ORGAN WEIGHTS: liver, kidneys, spleen, heart, adrenals, thyroid, pituitary gland
HISTOPATHOLOGY: Yes (same organs + macroscopic abnormalities) + Tissues preserved for possible microscopic examination: stomach, small intestine (3 sections), large intestine, pancreas, urinary bladder, testes, ovaries, salivary glands, lymph nodes, lungs, bone marrow (chondrocostal junction), muscle, thymus, brain, spinal cord - Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- BODY WEIGHT AND WEIGHT GAIN
Body weight gain over 12 weeks of dosing was significantly lower at 3160 and 10000 ppm than controls, as detailed in the table below.
FOOD EFFICIENCY
Total food intake over 12 weeks was unaffected, but Effective Food Utilization (calculated as g body weight gain per 100 g of food eaten) was significantly decreased at 10000 ppm compared to controls, as detailed in the table below.
ORGAN WEIGHTS
Mean absolute liver weight of males and females given 10000 ppm and females given 3160 ppm was significantly higher than that of controls, as detailed in the table below.
HISTOPATHOLOGY: NON-NEOPLASTIC
There was no histopathological correlates to increased liver weights.
Minimal focal thyroid hyperplasia was observed in 7 out of 10 rats (4 males + 3 females) given 10000 ppm, versus 2 cases in controls (one of which was diffuse).
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: body weight gain; liver weight (females)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
- Mean changes in body weight gain and Effective Food Utilization following 12 weeks of dosing:
Net body weight gain over 12 weeks (g) | Effective Food Utilization (g/100 g) § | |||
Concentration in food (ppm) | Males | Females | Males | Females |
0 | 283 | 150 | 17.2 | 12.0 |
100 | 286 | 147 | 17.5 | 11.7 |
316 | 273 | 148 | 17.6 | 11.9 |
1000 | 282 | 141 | 17.5 | 11.0 |
3160 | 259*** | 140** | 17.0 | 11.0 |
10000 | 225*** | 121*** | 16.1* | 10.0** |
§ Gram of body weight gain per 100 g of food eaten* p = 0.05 ** p = 0.01 *** p = 0.001 | ||||
- Mean relative liver weight at necropsy:
Males | Females | |||
Concentration in food (ppm) | Liver weight (% body weight) | Change versus controls (%) | Liver weight (% body weight) | Change versus controls (%) |
0 | 3.56 | - | 3.48 | - |
100 | 3.05 | -14 | 4.00 | +15 |
316 | 3.68 | +3 | 3.75 | +8 |
1000 | 3.61 | +1 | 3.80 | +9 |
3160 | 3.91 | +10 | 4.50** | +29 |
10000 | 5.20*** | +46 | 5.41*** | +55 |
** p = 0.01 *** p = 0.001 |
Applicant's summary and conclusion
- Conclusions:
- Dietary administration of TSP/DSP to rats for 90 days resulted in significantly decreased body weight gain (at 3160 and 10000 ppm), reduced food efficiency (at 10000 ppm), increased relative liver weight (at 3160 ppm for females and 10000 ppm for both sexes) with no histopathological correlates, and minimal focal thyroid hyperplasia at 10000 ppm.
The NOAEL was therefore considered to be 1000 ppm, corresponding to approximately 40 or 50 mg/kg, for males or females, respectively.
TSP/DSP is not classified for repeat-dose toxicity according to the criteria of Annex VI Directive 67/748/EECor UN/EU GHS. - Executive summary:
In a 90-day dietary toxicity study (Food and Drug Research Laboratories study No.81351), Wingstay S (Styrenated Phenol, TSP/DSP) was administered as a dietary admixture to 30 rats/sex/dose (60/sex for controls) of unspecified strain and age, at dose levels of 0, 100, 316, 1000, 3160 and 10000 ppm, approximately equivalent to 0, 4, 12.6, 40, 126.4 and 400 mg/kg (males) or 0, 5, 15.8, 50, 158 and 500 mg/kg (females) based on standard food intake values, daily for 90 days. Examinations and measurements included mortality and clinical signs, body weight and body weight gain, food consumption and efficiency, hematology, coagulation, clinical chemistry (blood glucose, urea nitrogen and cholesterol, liver cholesterol) and urinalysis, at 12 weeks of dosing. Five rats per sex and per dose (10 for controls) were killed and necropsied at 90 days of dosing. Liver, kidneys, spleen, heart, adrenals, thyroid and pituitary gland were weighed and microscopically examined.
There were no relevant changes in mortality, clinical signs, food consumption, clinical pathology or urinalysis between groups including controls.
Body weight gains over 12 weeks of dosing were statistically significantly lower at 3160 and 10000 ppm than in controls. This was associated with a decrease in food efficiency at 10000 ppm, when compared to controls.
At necropsy, increases in relative liver weight were reported for males and females given 10000 ppm and females given 3160 ppm (+29% to +55% versus controls). No liver abnormalities were detected at microscopic examination.
An increased incidence of minimal focal thyroid hyperplasia was observed at 10000 ppm.
The NOAEL is considered to be 1000 ppm following 90 days of dosing, corresponding to approximately 40 or 50 mg/kg for males or females, respectively, based on statistically significant effects on body weight gain (both sexes) and on liver weight (females).
TSP/DSP is not classified for repeat-dose toxicity according to the criteria of Annex VI Directive 67/748/EECor UN/EU GHS.
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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