Glycerol

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 followed

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

Species:

rabbit

Strain:

other: albino

Details on test animals or test system and environmental conditions:

Reference Method:
Male albino rabbits in good health and weighing at least 2.0 kg each were used for each group of 4 materials. Immediately prior to applying the materials the hair was removed from the backs of the animals with electric clippers in such a way as to avoid abrasions. The clipped area was wide enough to accommodate 4 gauze pads without overlapping. The animals were placed in restraint at the time the materials were applied and they remained immobilized during the 24-hour exposure period.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 ml of test material was applied to the center of the gauze patch.

Duration of treatment / exposure:

24 hours

Observation period:

Reference Method:
Twenty-four hr after application the patches were removed, and 30 min later the skin sites examined. The examination was repeated 48 hr later (72 hr after application). Scoring of the reactions was based on the amount of erythema, edema, and necrosis found. Necrosis was defined in this instance as "chemical denaturation of tissue sufficiently severe to result in fibrotic replacement (scar tissue). Superficial eschar which heals without scar is not classified as necrosis." The skin reaction scores of each animal in each category at 24 and 72 hr after application were added. The total score for all 8 rabbits was divided by 16 to yield a Primary Irritation (PI) score for a given material

Number of animals:

8 male rabbits were used.

Details on study design:

No additional information available.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Remarks on result:

other: the primary irritation index was rated >/= 2 by all 14 testing laoratories

Irritant / corrosive response data:

The Primary Irritation Index was rated

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:

Glycerin was considered to be non irritating to the skin in rabbit irritation studies in 14 testing laboratories.

Executive summary:

A round-robin testing program was conducted in 14 laboratories. The dermal irritation potential was examined. Glycerin was considered to be non irritating to the skin in rabbit irritation studies in 14 testing laboratories.