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Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non guideline, GLP animal experimental study, available as published report, but not fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
The protocol has been designed with reference to the Environmental Protection Agency, Pesticide Program, and the proposed TOSCA Health Effect Test Standard.
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Constituent 1
Reference substance name:
Phenylethyl alcohol
IUPAC Name:
Phenylethyl alcohol

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories Ltd.
- Age at study initiation: 8 weeks old
- Weight at study initiation: 175 to 225 g/ 200-250 at onset of acclimatation
- Fasting period before study:
- Housing: individually housed in stainless steel, wire meshd- bottom cages.
- Diet (e.g. ad libitum): Certified Purina Laboratory Rat Chow diet
- Water (e.g. ad libitum): tap woter ad libitum except during the four hour inhalation exposure
- Acclimation period: 1week minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
inhalation: aerosol
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:
- Exposure chamber volume: 27'' cube (400 liter volume) stainless steel whole body exposure
- Method of holding animals in test chamber:
- Source and rate of air: 45 L/min
- Method of conditioning air: Air was decontamined by using HEPA filter, an activated charcoal filter and liquid scrubber prior to eliminating it from the facility
- System of generating particulates/aerosols: An aerosol of the test article was generated using a Thermo System Inc. six jet atomizer- used at pressure of 9 psig with 2 jets in operation.
- Method of particle size determination:
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber: Monitored hour by hours by means of remote sensors (YSI model 705 Temperature Probe and 91 HD Dew Point Hygrometer)- Temperature and humidity were respectively 25.4 °C and 34.8%:

TEST ATMOSPHERE
- Brief description of analytical method used: Hourly air samples were collected for measurements of chamber concentration at rate of 5 L/min for two minutes, through a preweighted Gelman glass fibre filter paper. Chamber concentration was calculated from the increase in weight of the filter and volume of air sample.
Hourly air samples from inhalation chamber for particle size analysis were withdrawn and passed through a Casella cascade Impactor.
- Samples taken from breathing zone: yes

VEHICLE
- Composition of vehicle (if applicable):
- Concentration of test material in vehicle (if applicable):
- Justification of choice of vehicle:
- Lot/batch no. (if required):
- Purity:

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration:
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Nominal concentration was 4.63 mg/l resulting in a measured chamber concentration of 1.38 mg/l.
No. of animals per sex per dose:
1 Group: 5 females and 5 males
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.63 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: All animals survived to scheduled study termination
Mortality:
No deaths.
Clinical signs:
other: Non clinical signs of possible toxicological importance were observed.
Body weight:
Small body weight losses were observed on the days following the exposure. The losses were recovered by Day 7.
Gross pathology:
LUNGS: Multiple greyish- green focal areas scattered throughout alla lobes with several dark red areas present on the right cranial lobe. Congestion, mild, diffuse.
KIDNEYS: Slightly pale
Other findings:
LUNGS: Chronic repsiratory disease, modeate to severe. Pulmonary edema and congestion, only one section.
BRONCHIAL LYMPH NODES: Enlarges
KIDNEYS: No pathological alterations

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Phenyl Ethyl Alcohol administrated by inhalation route did not produce any systemic toxicity in the albino rat. Lung and bronchial outcomes were considered to be spontaneous and caused by a mild infection with murine respiratory mycoplasmosis. Pulmonary edema was attributed to euthanasia. The acute LC50 was concluded to be greater than 4.63 mg/l expressed in terms of nominal concentration.
Executive summary:

The study investigated the effect of Pheny ethyl alcohol in females and males of Sprague- Dawley rats. 25 males and 25 females were exposed by inhalation route to 4.63 mg/l (nominal concentration), which resulted in a measured chamber concentration of 1.38 mg/l of the test material for 4 hours.

The treatment was carried on in a 27'' cube stainless steel and glass whole body exposure chamber and signs of mortality and visible toxic effect were hourly recorded. The observation period covered 14 days after dosing. Body weight, gross pathology, histopatology, clinical signs were recorded. The results of the study demonstrated that there were no moralities due to the exposure to Phenyl Ethyl Alcohol. Change at polmonar, bronchial and kidney level, partial loss of weight were observed, but they were attributed to infection.The acute LC50 was concluded to be 4.63 mg/l expressed in terms of nominal concentration and it is not classifiable for acute inhalation toxicity.