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EC number: 203-632-7 | CAS number: 108-95-2
- 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:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is comparable to OECD guideline 451 with acceptable restrictions (carcinogenicity study, limited parameters tested concerning repeated dose toxicity; no 3rd dose level; oesophagus, musculature, peripheral nerve, spinal cord, eyes were not examined histopathologically; no data about change of test substance solutions in drinking water).
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Bioassay of phenol for possible carcinogenicity.Report of the National Cancer Institute
- Author:
- NIH
- Year:
- 1 980
- Bibliographic source:
- NIH Publication No. 80-1759
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 451 (carcinogenicity study)
- Deviations:
- yes
- Remarks:
- (no 3rd dose level; in histopathology some organs recommended in OECD451 were not evaluated)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Phenol
- EC Number:
- 203-632-7
- EC Name:
- Phenol
- Cas Number:
- 108-95-2
- Molecular formula:
- C6H6O
- IUPAC Name:
- phenol
- Details on test material:
- Reagent grade; Lot No. 79380 from Textile Chemical Company,. Reading, Pa; melting point and elemental analyses close to literature and with theoretical values.
Purity 98.47% (U.S.P. titration method, U. S. Pharmacopeia, 1975).
Pilot study:
United States Pharmacopoeia grade Lots No. A4X and B4A from Eastman Kodak Company, Rochester, N. Y.; melting point and elemental analyses close to literature and with theoretical values.
All batches:
storage at room temperature in original containers
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: NCr Frederick Cancer Research Center (Frederick, Maryland)
- Age at study initiation: 5-6 weeks
- Fasting period before study: no
- Housing: three per cage
- Diet and drinking water ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 40-50
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- other: tap water
- Details on oral exposure:
- Test solutions prepared by completely dissolving weighed amount of phenol in a measured volume of tape water; solution diluted to the desired final volume specified concentrations.
No further data. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of the test solutions analyzed by gas chromatography: mean concentration of eight samples (nominal 5000 ppm) was 5,237+-509 ppm
- Duration of treatment / exposure:
- 103 weeks
- Frequency of treatment:
- daily ad libitum
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 2500, 5000 ppm
Basis:
other: nominal in water; analytical concentration of the high dose: 5237+-509 ppm
- Remarks:
- Doses / Concentrations:
ca. 200 and 450 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Controls in the same room; no further details
post exposure observation period: 1-2 weeks - Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- Observations of animals twice daily; clinical signs and palpable masses (tumours) recorded weekly; mean body weights and food consumption reported every 2 weeks for the first 12 weeks and then monthly; water consumption recorded weekly.
- Sacrifice and pathology:
- Moribund animals & survivors at termination killed by i.p. sodium pentobarbital; necropsy performed.
Histopathology
All gross lesions plus the following organs examined microscopically: skin, lungs and bronchi, trachea, bone and bone marrow, spleen, lymph nodes, heart, salivary gland, liver, pancreas, stomach, small intestine, large intestine, kidney, urinary bladder, pituitary, adrenal, thyroid, parathyroid, mammary gland, prostate or uterus, testis or ovary, and brain. Occasionally, additional tissues also examined (no further data). - Other examinations:
- no
- Statistics:
- Survival:
product-limit procedure of Kaplan and Meier (1958); statistically censored; dose-related effect using the method of Cox (1972) for testing two groups for equality and
Tarone's (1975) for testing for a dose-related trend.
All paramters:
One-tailed P values, exception: departure from linearity test, which is reported only when its two-tailed P value is less than 0.05.
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:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No effects
BODY WEIGHT AND WEIGHT GAIN
At >= 20 weeks of exposure mean body weight was lower in the high dose groups than those of the controls.
WATER CONSUMPTION AND COMPOUND INTAKE
Water consumption of the low- and high-dose groups was 80% and 90% of control value, respectively (comment: no reporting error; compare with dose actual ingested).
GROSS PATHOLOGY
No effects reported.
HISTOPATHOLOGY: NON-NEOPLASTIC
The inflammatory, degenerative, and hyperplastic lesions were similar in number and kind to those that naturally occur in aged F344 rats.
HISTOPATHOLOGY: NEOPLASTIC
no effects; see Section 7.7
Effect levels
open allclose all
- Dose descriptor:
- LOEL
- Effect level:
- 2 500 ppm
- Sex:
- male/female
- Basis for effect level:
- other: reduced water consumption (200 mg/kg bw/day)
- Dose descriptor:
- LOEL
- Effect level:
- 5 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: reduced body weight (450 mg/kg bw/day)
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: corresponding to 450 mg/kg bw/day; NOAEL because reduced body weight related to reduced water consumption; limited number of parameters tested (carcinogenicity study)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a chronic drinking water study in rats phenol resulted in reduced water consumption and secondary in reduced body weight gain. The NOAEL was 5000 ppm or 450 mg/kg bw/day.
- Executive summary:
The study is comparable to OECD guideline 451 with acceptable restrictions (carcinogenicity study, limited parameters tested concerning repeated dose toxicity; no 3rd dose level; oesophagus, musculature, peripheral nerve, spinal cord, eyes were not examined histopathologically; no data about change of test substance solutions in drinking water).
In a 103 -weeks cancer studies on male and female F344 rats (n=50 per dose per sex) animals were exposed to 0, 2500 or 5000 ppm phenol (purity 98.5%) in the drinking water (ca. 200 and 450 mg/kg bw/day). In both treatment groups the water consumption was decreased (80% and 90% of control value, respectively) and in the high dose groups the body weight was reduced. No clinical signs of toxicity were recorded. No treatment related effects were detected in histopathological evaluation of non-neoplastic effects. No treatment-related increased tumour incidences were found (see Section 7.7).
Conclusion: In a chronic drinking water study in rats phenol resulted in reduced water consumption and secondary in reduced body weight gain. The NOAEL was 5000 ppm or 450 mg/kg bw/day.
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