2,3-epoxypropyl isopropyl ether

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: publication

Adequacy of study:

key study

Reliability:

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

Reference Type:

publication

Title:

The Toxicology of Glycidol and Some Glycidyl Ethers

Author:

Hine HC, Kodama JK, Wellington JS, Dunlap MK, Anderson HH

Year:

1956

Bibliographic source:

AMA Archives of Industrial Health. (Chicago, IL) 14,250,1956

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not applicable

GLP compliance:

no

Remarks:

conducted prior to GLP implementation

Test material

Test material information

Constituent 1

Reference substance name:

Isopropyl glycidyl ether

IUPAC Name:

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 / tissue source

Species:

rabbit

Strain:

other: California Albino or New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: rabbitry at Point Reyes, Calif., or Gilroy laboratory, Calif.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated second eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

no information given on wash-out after instillation

Observation period (in vivo):

at least 48 h

Number of animals or in vitro replicates:

no data

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: mean after 1, 24, 48 h

Score:

40

Reversibility:

fully reversible

Remarks on result:

other: Scoring according to Draize (Draize JH: Procedures for the Appraisal of the Toxicity of Chemicals in Food, Drugs, and Cosmetics: VIII. Dermal Toxicity, Food, Drug, & Cos Law . 10:722, 1955)

Applicant's summary and conclusion

Interpretation of results:

other: moderately irritating (criteria used for interpretation of results: Draize scoring)

Conclusions:

The studied was conducted scientifically reasonable with sufficient documentation similar to OECD 405, it was assessed with Klimisch 2. Hence, the results are sufficiently reliable to assess the eye irritating properties of isopropyl glycidyl ether in rabbits. With an irritation score of 40, the substance is considered as moderate irritant according to Draize.

Executive summary:

In a primary eye irritation study similar to OECD 405, 0.1 mL of unchanged Isopropyl glycidyl ether was instilled into the eye of male California Albino or New Zealand White rabbits. Animals then were observed for at least 48 h.  Irritation was scored by the method of Draize.

In this study, Isopropyl glycidyl ether is a moderate eye irritant.