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EC number: 203-632-7 | CAS number: 108-95-2
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study insufficiently documented and experimental design has some limitations (no data about control, one dose, several parameters mentioned in current guideline not measured, no details about the test substance)
Data source
Reference
- Reference Type:
- publication
- Title:
- Phenol studies VII. Chronic phenol poisoning, with special reference to the effects upon experimental animals of the inhalation of phenol vapor
- Author:
- Deichmann WB, Kitzmiller KV, Witherup S
- Year:
- 1 944
- Bibliographic source:
- Amer J Clin Pathol 14: 273-277
Materials and methods
- Principles of method if other than guideline:
- Toxic effects after inhalation exposure in rats at a dose level of 100-200 mg/m³
- GLP compliance:
- no
- 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:
- No details
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No details
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Remarks on MMAD:
- MMAD / GSD: vapour
- Details on inhalation exposure:
- Six rabbits, 15 rats and 12 guinea pigs were exposed together (7 h/d, 5 days per week) to vapours of phenol at a concentration 100-200 mg/m³. The inhalation chamber had a capacity of 600 l; 170 l/minutes passed through; the temperature in the chamber ranged from 27° to 32°C and the relative humidity between 46 and 70%. No further data.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Authors description of analytical methods:
" Introduce 80 ml of 1 per cent sodium hydroxide into the flask cont.aining the sample (volume) and shake for 15 minutes. The resultant sodium phenolate and the excess of sodium hydroxide are drained into a 100 ml volumetric flask, and the sampling flask is washed with about 8 ml of water. To samples and washings are then added 2 N hydrochloric acid, the quantity of which (about 9 ml.) must. be determined by preIiminary titration so as to bring the pH of the final solution between 11 nd 12. Water is then added to the 100 ml mark. A20 ml aliquot is analyzed and to this are added 4 ml of sodium acetate and 2 ml of the diazotized p-nitroaniline reagent followed one minute Iater by 4 ml of 20 per cent sodium carbonate. The intensity of color, representing the concentration of phenol, is read in a spectrophotometer (10 mm cups) within 3 minutes, at wave length 500 µm. The relation between density and concentration is obtained by reference to a calibration curve, that must be prepared in advance. The result gives the concentration of phenol in the 20 ml aliquot and from this the concentration in the entire sample can be calculated. " - Duration of treatment / exposure:
- 74 day (ca. 11 weeks)
- Frequency of treatment:
- 7 h per day, 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100-200 mg/m³
Basis:
analytical conc.
- No. of animals per sex per dose:
- 15 rats
- Control animals:
- not specified
- Details on study design:
- No details
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- clinical signs determined (no details)
- Sacrifice and pathology:
- Necropsy performed at termination.
Histopathology; presumably the following organs were examined: liver, lung, kidney, heart. - Other examinations:
- At termination carcasses were ground up and analyzed for phenol (no details)
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- 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:
- No clinical signs; no effects at necropsy and at histopathology.
At termination the average quantity of "free" phenol found was about 0.2 mg%, of conjugated phenol ahout 0.35 mg%, and of total phenol about 0.6 mg per 100 g tissue; these data represented normal vallues for tissue phenol in rats (no further details).
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 100 mg/m³ air
- Sex:
- not specified
- Basis for effect level:
- other: no clinical signs, no effects at necropsy or at histopathology (one dose; limited validity)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a subchronic inhalation study of limited validity no adverse effects were found in rats exposed to 100-200 mg/m³.
- Executive summary:
The study is insufficiently documented and the experimental design has some limitations (no data about control, one dose, several parameters mentioned in current guideline not measured, no details about the test substance) but the available data supported the results in the 2 -week inhalation study by Hoffman et al., 2001.
15 rats were exposed 7 hours per day, 5 days per week for 74 day (ca. 11 weeks) to 100 -200 mg/m³. No clinical signs were observed during exposure period. No effects were detected at necropsy and in histopathological examination of liver, lung, kidney and heart.
Conclusion: In a subchronic inhalation study of limited validity no adverse effects were found in rats exposed to 100-200 mg/m³.
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