2,3-epoxypropan-1-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not documented

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

The toxicology of glycidol and glycidyl ethers

Author:

Hine, C.H. et al.

Year:

1956

Bibliographic source:

Arch. Ind. Health 14, 250-264 (1956)

Report date:

1956

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test was conducted in male rabbits and scored using the Draize method

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2,3-epoxypropan-1-ol

EC Number:

209-128-3

EC Name:

2,3-epoxypropan-1-ol

Cas Number:

556-52-5

Molecular formula:

C3H6O2

IUPAC Name:

(oxiran-2-yl)methanol

Details on test material:

- Name of test material (as cited in study report): Glycidol
- Molecular weight (if other than submission substance): 74.05
- Physical state: Liquid

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: Point Reyes, California or Gilroy Laboratory, California.
- Age at study initiation: Not documented
- Weight at study initiation: 2 - 3kg
- Housing: Not documented
- Diet (e.g. ad libitum): Not documented
- Water (e.g. ad libitum): Not documented
- Acclimation period: Not documented

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not documented
- Humidity (%): Not documented
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): Not documented

IN-LIFE DATES: From: To: Not documented

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

100 µL

Duration of treatment / exposure:

48 hours

Observation period (in vivo):

48 hours. Readings were made at 1, 24 and 48 hours after treatment.

Number of animals or in vitro replicates:

Not documented

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not documented
- Time after start of exposure: Not relevant

SCORING SYSTEM: Draize method

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1, 24 and 48 h

Score:

68

Max. score:

102

Reversibility:

not specified

Remarks on result:

other: Score is the average for the 3 readings.

Irritant / corrosive response data:

severely irritating

Other effects:

No information provided

Any other information on results incl. tables

Average Draize score: 68
No blindness or permanent defects in the cornea, lens, or iris.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information The Kay and Calendra type score was 68 on a scale of 0 -110. Concluded to be a moderate irritant Criteria used for interpretation of results: OECD GHS

Conclusions:

In this eye irritation study in rabbits glycidol was severely irritating. However, no blindness or permanent defects in the cornea, lens or iris resulted. Under the conditions of this study, due to the lack of information on the number of animals tested and the individual scores for corneal, iris and conjunctival effects and the reversibility of the effects observed, it was not possible to determine a classification according to Regulation EC no. 1272/2008 or Directive 67/548/EEC. However, the material appears to be a moderate irritant and was assigned a GHS Category 2 (Irritating to eyes) classification and by read acoss to Directive 67/548/EEC was assigned R36 Irritating to eyes.

Executive summary:

In a study conducted by Hine et al (1956), the test substance, Glycidol, was examined for its ability to cause irritation when applied to the eye of male Californian albino or New Zealand White rabbits. 100ul of the test substance was applied to one eye of each rabbit, with the other serving as the control. Following application, readings were made at 1, 24 and 48 hours post exposure. The mean of these three scores was used to evaluate the effects. In this eye irritation study in rabbits glycidol was severely irritating. However, no blindness or permanent defects in the cornea, lens or iris resulted. Under the conditions of this study, due to the lack of information on the number of animals tested and the individual scores for corneal, iris and conjunctival effects and the reversibility of the effects observed, it was not possible to determine a classification according to Regulation EC no. 1272/2008 or Directive 67/548/EEC.