Registration Dossier

Toxicological information

Skin irritation / corrosion

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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

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.