Registration Dossier

Toxicological information

Eye irritation

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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

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.