Glycerol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results

Data source

Reference

Reference Type:

publication

Title:

Study of Intra- and Interlaboratory Variability in the Results of Rabbit Eye and Skin Irritation Tests

Author:

Weil, C. S., Scala, R. A.

Year:

1971

Bibliographic source:

Toxicol. Appl. Pharmacol., 19, 276-360

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Glycerine was one of several chemicals sent to various laboratories as part of a round robin testing program. Each laboratory used their own method as well as referenced methods.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol

EC Number:

200-289-5

EC Name:

Glycerol

Cas Number:

56-81-5

Molecular formula:

C3H8O3

IUPAC Name:

propane-1,2,3-triol

Details on test material:

No additional information available.

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Reference Method for Eye Irritation Test
Animals. Six male albino rabbits in good health, weighing at least 2.0 kg each, were used for each material. The eyes were free of defects and irritation, and 24 hr prior to application of test material the eyes were stained with an aqueous 5 % solution of sodium fluorescein. The stain was allowed to contact the eyes for 20 sec and was flushed thoroughly with distilled water at room temperature. The eyes were then examined for possible corneal lesions not otherwise visible. Three left and 3 right eyes were used for each sample. The animals were housed singly and free of any extraneous material which might cause irritation.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

Maximum of 7 days.

Observation period (in vivo):

Scoring and evaluation The eyes were examined and the degree of irritation recorded at 1, 24, and 72 hr and 7 days after application of the sample. Observations on any animal were discontinued after 24 or 72 hr if the eyes were free of irritation. Fluorescein staining was done at 24 and 72 hr and 7 days on the eyes of animals not previously negative. The grading of eye irritation was according to the scale of Draize et al. (1944). Injuries such as pannus, keratoconus, and sloughing of corneal epithelium were not included in the Draize system and were recorded separately.

Number of animals or in vitro replicates:

6 animals from each testing laboratory

Details on study design:

Application. The lower lid was pulled away from the eye to form a cup into which 0.1 ml of material was instilled. The lid was held open for a few seconds, then raised to close with the upper lid. The 2 lids were held gently together for a few seconds before the animal was released. The eyes were not washed following instillation.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hr

Score:

<= 2

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: Generally considered non-irritating, no score provided

Irritant / corrosive response data:

Tests were conducted in 20 laboratories. In 19 laboratories, glycerin was considered to be non-irritating. In the remaining laboratory, the response observed with glycerin was of questionable irritation.

Other effects:

No additional information available

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the results obtained from 20 different testing laboratories, glycerin was considered to be nonirritating in 19 laboratories and of questionable irritation in one laboratory.

Executive summary:

A round-robin testing program was conducted in 20 laboratories. The eye irritation potential was examined.

Based on the results obtained from 20 different testing laboratories, glycerin was considered to be nonirritating in 19 laboratories and of questionable irritation in one laboratory.