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EC number: 205-055-6 | CAS number: 132-27-4
- 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:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
- Reference Type:
- secondary source
- Title:
- O-Phenylphenol and its Sodium and Potassium Salts: A Toxicological Assessment
- Author:
- Bomhard, E. M. et al.
- Year:
- 2 002
- Bibliographic source:
- Crit. Rev. Toxicol. 32(6):551-626
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-1 (Chronic Toxicity)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents)
- Version / remarks:
- (1998)
- Deviations:
- yes
- Remarks:
- the animals were dosed for 1 year and only 4 animals/dose/sex were used for the study
- GLP compliance:
- yes
Test material
- Reference substance name:
- Biphenyl-2-ol
- EC Number:
- 201-993-5
- EC Name:
- Biphenyl-2-ol
- Cas Number:
- 90-43-7
- Molecular formula:
- C12H10O
- IUPAC Name:
- 2-phenylphenol
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): Ortho-phenylphenol, OPP
- Molecular formula: C12H10O
- Molecular weight: 170.1 g/mol
- Physical state: solid
- Analytical purity: 99.7%
- Composition of test material, percentage of components: mixture of equal amounts of OPP obtained from Mobay Corporation (Pittsburgh, PA) and The Dow Chemical Company (Midland, MI)
- Lot/batch No.: BK553730 (Mobay Corporation) and MM 880330 (The Dow Chemical Company)
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Marshall Research Animals (North Rose, NY)
- Age at study initiation: approximately 4 months
- Housing: individually in cages made of stainless steel, 1 x 1.3 x 1.3 m (witdth x length x hight); stacked two high; equipped with flattened-tube grid flooring with underlying tilt pants to faciliate cleaning, a stainless steel feeder, and a pressure activated water nipple
- Diet: basal diet in pelleted form of Purina Certified Laboratory Dog Chow #50007 (Ralston Purina Co., St. Louis, MO), ad libitum
- Water: municipal drinking water, ad libitum
- Acclimation period: at least 30 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Dosing solutions were prepared at least weekly by melting known amounts of solid OPP at 80°C in a water bath and mixing in a volumetric flask with preheated (70-80°C) food grade peanut oil using a stir bar for approximately 10 min. Additional warmed peanut oil was added using the numeber of dilution steps andmixing needed. Following cooling of the OPP-peanut oil mixtures to room temperature to allow for temperature-related changes in volume, dosing solutions were adjusted to appropriate volumes with peanut oil at ambient tempreature and stirred for an additional 5 min to ensure a homogenous mixture. Dosing solutions were stored at room temperature.
VEHICLE
- Justification for use and choice of vehicle (if other than water): solubility of test substance and availability of reliable supplier
- Amount of vehicle (if gavage): 3-5 mL dosing volume
- Supplier: Somillo brand, Suffolk Oil Mill, Inc., Suffolk, VA or Gordon Food Service, Bay City, MI
- Purity: food grade - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Aliquots of the 300 nd 1000 mg/kg dosing solutions were analysed to verify targeted test material concentrations. The results indicated and acceptable agreement between the observed versus targeted concentrations of OPP in peanut oil.
- Duration of treatment / exposure:
- 1 year
- Frequency of treatment:
- 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30, 100 300 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on a preliminary four week toxicity study
- Rationale for animal assignment (if not random): by body weight, whereas litter mates of the same sex were not assigned to the same treatment groups
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least once daily
- Cage side observations included: animal's movement within the pen, general health status including evidence of cchanges in dietary intake, faecal production, emesis, and evidence of untoward effects related to treatment
BODY WEIGHT: Yes
- Time schedule for examinations: weekly during the first 13 weeks, monthly thereafter
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: pre-exposure and pre-termination
- Dose groups that were examined: all dogs
HAEMATOLOGY: Yes
- Time schedule for collection of blood: twice prior to initiation of dosing, after 3 and 6 months and prior to termination
- Anaesthetic used for blood collection: No
- Animals fasted: Yes (overnight)
- How many animals: all dogs
- Parameters checked included: haematocrit, haemoglobin, erythrocyte count, total and differential leukocyte count, platelet count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: twice prior to initiation of dosing, after 3 and 6 months and prior to termination
- Animals fasted: Yes (overnight)
- How many animals: all dogs
- Parameters checked included: alkaline phosphatase, alanine transaminase, aspartate transaminase, creatinine phosphokinase, serum urea nitrogen, creatinine, total protein, albumin, globulin, glucose, total bilirubin, cholesterol, triglycerides, Na, K, Ca, Cl, and P
URINALYSIS: Yes
- Time schedule for collection of urine: after 6 months and during necropsy
- Metabolism cages used for collection of urine: No
- Parameters checked included: semiquantitative determination of pH, bilirubin, glucose, proteins, ketones, occult blood, urobilinogen, specific gravity, colour, appearance and microsediment - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
ORGAN WEIGHTS: Yes (brain, liver, kidneys, thyroid with parathyroid, pituitary, adrenals, ovaries, testes)
HISTOPATHOLOGY: Yes (brain, liver, kidneys, thyroid with parathyroid, pituitary, adrenals, ovaries, testes, lung, eyes, urinary bladder, bone marrow)
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- pronounced emetic response
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- pronounced emetic response
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- 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:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Two high dose males (300 mg/kg bw/day) died after test days 137 and 138 due o inadvertent deposition of dosing solutions in the lungs.
Dose-related emetic activity was noted in all animals during the in-life phase. In general, emetic activity was observed to occur more frequently in and to involve greater volumes in the high dose group (300 mg/kg bw/day) than in dogs of the other dose groups (30 and 100 mg/kg bw/day).
BODY WEIGHT AND WEIGHT GAIN
There was no test material-related effect noted.
FOOD CONSUMPTION
There was no test material-related effect noted.
OPHTHALMOSCOPIC EXAMINATION
There was no test material-related effect noted.
HAEMATOLOGY
There was no test material-related effect noted.
CLINICAL CHEMISTRY
There was no test material-related effect noted.
URINALYSIS
There was no test material-related effect noted.
NEUROBEHAVIOUR
ORGAN WEIGHTS
There was no test material-related effect noted.
GROSS PATHOLOGY
There was no test material-related effect noted.
HISTOPATHOLOGY: NON-NEOPLASTIC
There was no test material-related effect noted.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The pronounced emetic response/resultant loss of test material after gavage precluded the administration of higher dose levels to the Beagle dog. The finding was not considered a true adverse effect.
Target system / organ toxicity
- Critical effects observed:
- not specified
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.
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