Triglycerides, C16-C18 (even numbered) and C18 (unsaturated), maleated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles. As the substance is a breakdown product of the target substance, this study is considered valid for read-across.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

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

Author:

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

Year:

1971

Bibliographic source:

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

Reference 2

Reference Type:

secondary source

Title:

OECD SIDS Initial Assessment Report For SIAM 14 - Glycerol

Author:

OECD

Year:

2002

Bibliographic source:

http://www.inchem.org/documents/sids/sids/56815.pdf

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

During a study on interlaboratory testing program, glycerol was used together with various other substances. A reference method and non-reference method have been used by the different laboratories.

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

IUPAC Name:

glycerol

Test animals

Species:

rabbit

Strain:

other: Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: Male
- Weight at study initiation: at least 2 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: yes, other substances used

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

24 h

Observation period:

24 and 27 h after patch removal

Number of animals:

8

Details on study design:

TEST SITE
- Area of exposure: Shaved back of animals
- Preparation: 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-hr exposure period.
- Type of wrap if used: Four gauze patches, each 1” x 1” cut from nonsterile, 12-ply material, were fixed to the application sites on each animal by means of l/2-inch adhesive tape applied in the shape of an X and wrapped with an impervious Saran film supplied by (Dow Chemical Company) and held in place longitudinally with tape.

SCORING SYSTEM:
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 reacion 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.

Results and discussion

In vivo

Results

Irritation parameter:

other: Primal Irritation Score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

0 - < 0.4

Max. score:

30

Reversibility:

no data

Irritant / corrosive response data:

All 14 participating laboartories found glycerol to be no-irritating bases on the PIS of <0.4.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test results of the different laboartory participating the study show that Glycerol can be regarded as not irritating to skin.

Executive summary:

Glycerol was not found to be irritating to skin in survey evaluating intra- and interlaboratory variabilities in testing on skin and eye irritation. Beside laboratory-specific methods, a reference method has been used by the laboratories resulting in a primary irritation score to compare the results.