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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:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP study equivalent to OECD guideline 403

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-propoxypropan-2-ol
EC Number:
216-372-4
EC Name:
1-propoxypropan-2-ol
Cas Number:
1569-01-3
Molecular formula:
C6H14O2
IUPAC Name:
1-propoxypropan-2-ol
Details on test material:
propylene glycol n-propyl ether (CAS 1569-01-3)

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratory, Kinsgton, NY
- Age at study initiation: 8 weeks
- Fasting period before study: n.a.
- Housing: individual housing in stainless steel wire mesh cages
- Diet (e.g. ad libitum): standard Purina diet ad libitum (except during exposure)
- Water (e.g. ad libitum): ad libitum (except during exposure)
- Acclimation period: minimum 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 50%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass and stainless steel Rochester-type chambers under dynamic airflow conditions
- Exposure chamber volume: 112 liter
- Source and rate of air: 30 liters/min
- Method of conditioning air: test material was pumped into a counter-current, multi-plated distillation colum where it was vaporized and mixed with compressed air
- Temperature, humidity in air chamber: 24-26°C, 31-32% humidity,


TEST ATMOSPHERE
- Samples taken from breathing zone: no (nominal chamber concentration was calculated based on the amount of test material used and the total amount of air that passed through the chamber during the xposure period)
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
0, 1725 ppm (highest concentration attainable at room temperature 25°C)
No. of animals per sex per dose:
6 male rats
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation-during exposure and at least once per day during observation period; weighing-on the first day and twice per week during observation period
Statistics:
Means and standard deviations of animal body weights were calculated for descriptive purposes.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC0
Effect level:
> 1 725 ppm
Exp. duration:
4 h
Remarks on result:
other: highest attainable concentration at room temperature
Mortality:
no mortality
Clinical signs:
other: none
Body weight:
Body weights of animals exposed to the test material were comparable to control values throughout the two week observation period and all animals appeared to be within normal health limits during the post-exposure period.
Other findings:
- Other observations: During exposure, the rats being exposed to the test material appeared to be slightly lethargic; rats in the control chamber appeared to be normal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, PnP should not pose any significant acute inhalation hazards in humans; although a slight sedative effect may occur with prolonged exposure to near-staurated atmospheres.
Executive summary:

Six male rats were exposed for four hours to vapors of propylene glycol propyl ether (PnP) at a nominal concentration of 1725 ppm. This was the highest concentration attainable at room temperature (25°C). Simultaneously, 6 male rats (serving as controls) were housed in a chamber supplied with clean, filtered air. Animals exposed to the test material appeared to be slightly lethargic during exposure. Mean body weights of exposed animals were comparable to to control values throughout the two week observation period and each animal appeared to be within normal health limits. No mortality was encountered in association with exposure to this test material. Based on the results of this study, PnP should not pose any significant acute inhalation hazards in humans. A slight sedative effect may occur however, with prolonged exposure to saturadted atmospheres.

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