Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

acute toxicity: inhalation
Type of information:
other: publication
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Sufficiently documented publication, scientifically reasonable method, testing performed on the registered substance itself.

Data source

Reference Type:
The Toxicology of Glycidol and Some Glycidyl Ethers
Hine HC, Kodama JK, Wellington JS, Dunlap MK, Anderson HH
Bibliographic source:
AMA Archives of Industrial Health. (Chicago, IL) 14,250,1956

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 403 (Acute Inhalation Toxicity)
not applicable
GLP compliance:
conducted prior to GLP implementation
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Reference substance name:
Isopropyl glycidyl ether
Isopropyl glycidyl ether
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Isopropyl glycidyl ether

Test animals

Details on test animals or test system and environmental conditions:
- Source: Commercial laboratory in Gilroy, Calif.
- Weight at study initiation: 110 - 140 g
- Housing: 6 rats per cage
- Diet (e.g. ad libitum): standard laboratory pellets

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
not specified
Details on inhalation exposure:
- Exposure apparatus: The motor-driven syringe assembly previously described by Hine and associates (Hine et al., Toxicology and Safe Handling of CBP-55, A. M.A. Arch. Indust. Hyg. 7:118, 1953) delivered measured amounts of the test compound from a 10 ml. Luer-Lok syringe into an evaporator through which metered air moved, at a uniform rate. The air flow was set at approximately 3 to 11 liters per minute, depending on the concentration desired. Nominal concentrations were calculated by the standard gas-concentration formula of Jacobs (Jacobs MB, Analytical Chemistry of Industrial Poisons, Hazards, and Solvents, New York, Interscience Publishers, Inc., 1949: vol. 1.) and were checked by determining the total quantity of material vaporized.
- Exposure chamber volume: 19.5 L
- Temperature, humidity, pressure in air chamber: 30±1°C
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
graded concentrations
No. of animals per sex per dose:
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 10 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
LD50 values were calculated by the method of Litchfield and Wilcoxon (Litchfield JT, Wilcoxon F, Simplified Method of Evaluating Dose-Effect Experiments, J Pharmacol & Exper Therap, 96:99, 1949

Results and discussion

Effect levels
Dose descriptor:
Effect level:
1 100 ppm
Based on:
test mat.
95% CL:
790 - 1 530
Exp. duration:
8 h
no details given
Clinical signs:
other: Dyspnea, lacrimation, salivation, nasal discharge, and aerophagia were much severer following vapor exposure than intragastric administration (see respective study in oral section), while depression of the central nervous system appeared usually as a ter
Body weight:
no details given
Gross pathology:
The commonest pathologic finding was irritation of the lungs, and pneumonitis was confirmed by microscopic examination.
Discoloration of liver and kidneys was also noted frequently on gross examination, but tissue changes were not consistently confirmed microscopically. In occasional livers focal inflammatory cells were observed, and moderate congestion of the central zones.
Other findings:
IPGE would not be classified as more than "moderately toxic" on single exposure, rather "slightly toxic" or "practically nontoxic" according to the classification of Hodge and Sterner.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
The studied was conducted scientifically reasonable with sufficient documentation similar to OECD 403, it was assessed with Klimisch 2. Hence, the results are sufficiently reliable to assess the acute toxicity of isopropyl glycidyl ether in rats. An inhalatory LC50 was determined as 1100 ppm, which needs to be converted into the unit mg/L as the tested substance was a vapour and classification of vapours according to Regulation 1272/2008 is foreseen in the unit mg/L. Therefore, the formula (ppm * molecular weight) / 24450 L/mol = mg/L is used, resulting in (1100 ppm * 116.1583 g/mol) / 24450 L/mol= 5.226 mg/L. This value is between the boundary values of 2.0 and 10.0 mg/L for classification as acute toxic Cat. III according to Regulation 1272/2008. Hence, the substance should be classified as acute toxic Cat. III and can be regarded as moderately toxic to rats.
Executive summary:

In an acute inhalation toxicity study (similar to OECD 403), groups of 6 male Long-Evans rats were exposed by inhalation route to vapour of 2,3-epoxypropyl isopropyl ether for 8 hours to whole body at graded concentrations. Animals then were observed for 10 days.


LC50Males = 1100 (95% C.I. 790 - 1530)


2,3-epoxypropyl isopropyl ether is classified as acute toxic Cat.III. The commonest pathologic finding was irritation of the lungs, and pneumonitis was confirmed by microscopic examination.