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Diss Factsheets
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EC number: 202-679-0 | CAS number: 98-54-4
- 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:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation
Data source
Reference
- Reference Type:
- other: unpublished
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- yes
- Remarks:
- no details provided on mating methods, or on housing or feeding of animals
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- 4-tert-butylphenol
- EC Number:
- 202-679-0
- EC Name:
- 4-tert-butylphenol
- Cas Number:
- 98-54-4
- Molecular formula:
- C10H14O
- IUPAC Name:
- 4-tert-butylphenol
- Details on test material:
- - Name of test material (as cited in study report): para-tertiary butylphenol, UCAR Butylphenol 4T-Flake (para tert-Butyl Phenol), PTBP.
- Physical state: White flakes.
- Analytical purity: Not reported.
- Lot/batch No.: Charge No. 496500; BRRC Sample No. 48-186.
- Expiration date of the lot/batch: Not reported.
- Stability under test conditions: Not reported.
- Storage condition of test material: Not reported.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Fasting period before study: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous methyl cellulose
- Details on oral exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): None given
- Concentration in vehicle: 0.5% - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- Males - 6 weeks
Females - from 14 days prior to mating to day 4 of lactation - Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20, 60, 200 mg/kg body weight
Basis:
actual ingested
- No. of animals per sex per dose:
- 13 animals/sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: None given
- Positive control:
- Not required
Examinations
- Observations and examinations performed and frequency:
- -General condition was observed (time schedule not reported)
-Food consumption (measured weekly)
- Body weights (measured weekly)
-Hematology (time schedule not reported). The following parameters were measured; red blood cell count, hemoglobin, hematocrit, MCV, MCH, MCHC, white blood cell count, band neutrophil, segmented neutrophil, eosinophil, basophil, monocyte, lymphocyte, and platelet count
-Serum biochemistry (time schedule not reported). The following parameters were measured: total protein, albumin A/G, BUN, creatinine, glucose, total cholesterol, total bilirubin, Na, K, Cl, Ca, inorg. phos., ALP, GPT, GOT, and gamma-GTP - Sacrifice and pathology:
SACRIFICE
- Male animals: All surviving animals
- Maternal animals: All surviving animals
GROSS NECROPSY
- Gross necropsy with recording of organ weights for the following organs; females - thymus, liver, and kidneys; males - thymus, liver, kidneys, testes, and epididymides
HISTOPATHOLOGY
Liver, kidney, thymus, spleen, lung, urinary bladder, stomach, testis, epididymis, and ovary tissues were prepared for microscopic examination
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- 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:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- 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:
- At 200 mg/kg body weight, some females showed stridor associated with dyspnea, likely caused by irritation of the respiratory tract. In males, decreased plasma albumin was reported in the 200 mg/kg body weight/day group. No compound specific morophological changes were observed following pathological examination of parental animals. Examination of body weights and gross morphology of the offspring revealed no effects of the compound administration. No adverse effects in pregnant and lactating females or their offspring were seen at any dose.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: Abnormal respiratory sounds in a females in and decreased plasma albumin in males was reported in the 200 mg/kg body weight/day
Target system / organ toxicity
- Key result
- 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.