2,3-epoxypropyl isopropyl ether

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal 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

Species:

rabbit

Strain:

other: California Albino or New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: rabbitry at Point Reyes, Calif., or Gilroy laboratory, Calif.
- Weight at study initiation: 2 - 3 kg

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped: scarified or intact

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

min. 24h, max. 72h, as there is no data on removal of test substance

Number of animals:

no data

Details on study design:

TEST SITE
- Area of exposure: back and flanks of rabbits were clipped 24 hours prior to use. The shoulders and hips were used as test sites, two areas on each animal being scarified and two intact.
- Type of wrap if used: patch consisting of three layers of gauze was secured over each area with adhesive tape, and 0.5 ml of the undiluted compound was introduced under the gauze. The rabbits were wrapped in towels.

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

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: mean of 24h and 72h

Score:

4.3

Reversibility:

no data

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)

Irritant / corrosive response data:

Moderate irritant

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 404, it was assessed with Klimisch 2. Hence, the results are sufficiently reliable to assess the skin irritating properties of isopropyl glycidyl ether in rabbits. With an irritation score of 4.3, the substance is considered as moderate irritant according to Draize.

Executive summary:

In a primary dermal irritation study similar to OECD 404, male California Albino or New Zealand White rabbits were

dermally exposed to 0.5 mL of unchanged Isopropyl glycidyl ether for 24 hours to the untreated or scarified skin of the hips and shoulders.  Animals were observed for at least 72 hours.  Irritation was scored by the method of Draize.

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