Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
Acute inhalation studies of glycol aerosols in rats - diethylene glycol, triethylene glycol, and 1,3-propanediol.
Author:
Cascieri T, Rinehart WE, Hoffman GM
Year:
1991
Bibliographic source:
Toxicologist 11: 145, Abstract 507, cited in MAK documentation 1995

Materials and methods

Principles of method if other than guideline:
Determination of the LC50 value.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
inhalation: aerosol
Mass median aerodynamic diameter (MMAD):
>= 2.6 - <= 3.1 µm
Remark on MMAD/GSD:
The mass median aerodynamic diameter (MMAD) of particles ranged from 2.6 to 3.1 µm and 96% were below 10 µm.
Duration of exposure:
4 h
Concentrations:
Maximum attainable concentrations of 4.4 to 4.6 mg/L were tested. The test concentration was the highest technically available aerosol concentration.
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 4.6 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: no animals died during the 14-day observation period
Mortality:
No mortalities occurred.
Clinical signs:
Clinical signs of toxicity consisted of decreased activity during exposure with rapid recovery on removal and nasal discharge or lacrimation suggestive of minor irritation, persisting for several days.
Body weight:
A transient body weight loss with recovery within 3 to 5 days was reported.
Gross pathology:
Post mortem examinations were unremarkable.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met