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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study precedes GLP and OECD guidelines, published in peer-reviewed literature, performed to non-standard protocol, but contributing to assessment.

Data source

Reference
Reference Type:
publication
Title:
Effect of the inhalation of a surface tension-reducing substance (propylene glycol) on the ultrastructure of the epithelium of the respiratory passages in rabbits
Author:
Konradova V, Vavrova V, Janota J
Year:
1978
Bibliographic source:
Folia Morphologica, 26, 28-34

Materials and methods

Principles of method if other than guideline:
Six rabbits were exposed for either 20 or 120 minutes to an aerosol of monopropylene glycol (10% in air). In each experimental group the tracheal epithelium of 3 rabbits was examined.
GLP compliance:
no
Test type:
other: evaluation of the effect of inhalation of monopropylene glycol on the respiratory tract epithelium in rabbits
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Weight at study initiation: 2000-3000 mg

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
other: air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:TRI-airborne infection apparatus
- Source and rate of air: 10 l air/minute
- System of generating particulates/aerosols: glass inhalator by Synek
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
>= 20 - <= 120 min
Remarks on duration:
Exposure duraction was either 20 min or 2 hours.
Concentrations:
10% monopropylene glycol in air (100000 ppm, 317041 mg/m3)
No. of animals per sex per dose:
3/dose
Control animals:
no

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 317 042 mg/m³ air
Exp. duration:
2 h
Other findings:
20 minutes inhalation of 10% propylene glycol produced minimal alteration of ciliated cells, but it represented a strong secretory impuls for the goblet ones. After shorter inhalation 16.5% of goblet cells filled with large pale mucous granules, 31% of mucus discharging and 52% of completely exhausted ones with highly electron dense degenerated cytoplasm were observed. After 2 hours inhalation of monopropylene glycol signs of ciliated cells' alteration were more pronounced and a slight drop in the number of intact mucus filled (12%) and mucus discharging goblet cells (19%) was accompanied by an increase in the number of exhausted degenerated ones (69%). The degenerated goblet cells were gradually expelled from the epithelium. Even after 2 hours' inhalation the signs of increased differentiation of new goblet cells were not noticed.

Applicant's summary and conclusion