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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study is comparable to OECD Guideline 403 with acceptable restrictions (only one dose level, nominal concentration, no data about purity of phenol, 8 h exposure instead recommended 4 h exposure). Phenol is a constituent of the reaction mass so that phenol hazard data are applied in the hazard assessment.

Data source

Reference
Reference Type:
publication
Title:
The benzenediols: catechol, resorcinol and hydroquinone - a review of the industrial toxicology and current industrial exposure limits
Author:
Flickinger CW
Year:
1976
Bibliographic source:
Am Ind Hyg Assoc J 37: 596-606

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
(only one dose level tested)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
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:
Source: Fisher Scientific company, catalogue no. A-91
No further data

Test animals

Species:
rat
Strain:
other: Harlan-Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Body weight at initiation: 87-126 g
No further details

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: water
Details on inhalation exposure:
Phenol was dissolved in distilled water (concentration: 8%) and the resulting solution was aerolised using a D18 Dautrebande aerosol generator operated at 30 psi. At this operating pressure, the generator delivered droplet diameters of 1μm size and smaller. The concentration of the sample solutions was adjusted so that airborne concentrations approximated 2000 mg/m3 of the sample in air. Airborne concentrations were determined by measurement of the volume loss of solution following aerosolisation. The weight of sample present in that volume was then calculated and related to the total volume of air used in generating the aerosol to obtain chamber concentrations.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
900 mg/m3
No. of animals per sex per dose:
6
Control animals:
other: untreated controls for comparison of body weight gain
Details on study design:
The nominal airborne concentration of the sample was calculated to be 900 mg/m3. Animals were held for 14 days following exposure and were then weighed and sacrificed for necropsy.
Statistics:
No data

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LC0
Effect level:
900 mg/m³ air (nominal)
Exp. duration:
8 h
Mortality:
No mortality within the 14 day post exposure observation period.
Clinical signs:
other: Ocular and nasal irritation; slight loss of coordination with spasms of muscle groups within 4 hours; tremors within 8 hours, one prostrate; rats were normal the first post exposure day. In the main result section severe coordination loss was reported.
Body weight:
No effects.
Gross pathology:
No lesions attributable to inhalation of the aerosol were detected.
Other findings:
No data

Any other information on results incl. tables

Phenol is a major component of the reaction mass and by its toxicity drives the hazard of the rection mass, so that phenol hazard data are applied in the hazard assessment.

Applicant's summary and conclusion

Conclusions:
No mortality at a dose level of 900 mg/m3 and an exposure duration of 8 h.
Executive summary:

The study is comparable to OECD Guideline 403 with acceptable restrictions (only one dose level, nominal concentration, no data about purity of phenol, 8 h exposure instead recommended 4 h exposure).

Six female Harlan-Wistar rats were exposed for 8 h to a phenol aerosol (vehicle water) at a nominal concentration of 900 mg/m3. The post exposure observation period was 14 days; necropsy was performed. No mortality was reported but ocular and nasal irritation as well as coordination loss and tremor during the exposure period. The rats appeared normal the next day. No effects were found on body weight gain and necropsy revealed no lesions attributable to inhalation of the aerosol. The LC50 should be > 900 mg/m3.

Conclusion: No mortality occurred at a dose level of 900 mg/m3 and an exposure duration of 8 h.