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

Eye irritation

Administrative data

Endpoint:

eye 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:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Limited reporting

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 comparable to OECD 405 and non-reference methods 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 / tissue source

Species:

rabbit

Strain:

other: Albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Sex: Male
- Age at study initiation:
- Weight at study initiation: At least 2 kg
- Housing: The animals were housed singly and free of any extraneous material which might cause irritation.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: yes, other substances used

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Single application without washing

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM:
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.
Observations on any animal were discontinued after 24 or 72 hr if the eyes were free of irritation.

TOOL USED TO ASSESS SCORE: Fluorescein (Fluorescein staining was done at 24 and 72 hr and 7 days on the eyes of animals not previously negative)

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 h

Score:

< 2

Max. score:

110

Reversibility:

fully reversible

Irritant / corrosive response data:

Glycerol was found to be non-irritating to eyes In 19 laboratories, while in one laboratory it results in questionable irritation.

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 eyes.

Executive summary:

Glycerol was not found to be irritating to eyes in survey evaluating intra- and interlaboratory variabilities in testing on skin and eye irritation. Beside laboratory-specific methods, a reference method comparable to OECD 405 has been used by the laboratories using the Draize scoring system to compare the results.