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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not stated
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 Type:
Study of Intra- and Interlaboratory Variability in the Results of Rabbit Eye and Skin Irritation Tests
Weil, C. S., Scala, R. A.,
Bibliographic source:
Toxicol. Appl. Pharmacol., 19, 276-360

Materials and methods

Test guideline
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:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
No additional information available.

Test animals

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:
Preparation of test site:
unchanged (no vehicle)
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

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
Migrated information Criteria used for interpretation of results: expert judgment
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.