Plant Sterols

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a scientifically acceptable protocol, and in compliance with GLP. There was limited information on the purity of the test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.3

Principles of method if other than guideline:

To determine the dermal corrosivity and primary dermal irritation, if any, when Generol 122 is applied to the skin of albino rabbits. On the day prior to dosing, the dorsal surface of each rabbit was clipped free of fur using electic clippers, with care taken to avoid accidental abrasion to the skin. A volume of 0.5 ml of test article was applied to each of the three sites per rabbit. The test sites were divided into one front site and two back sites separated by the spinal column. Prior to the application of the test substance the site on the right back side was abraded with the tip of a hypodermic needle. The abrasions were four incisions made in a cross hatch which oenetrated the stratum corneum but did not cause bleeding or disturb the dermis. Following application, each test site was occluded with a 1 inch square gauze patch held in place with tape and wrapped with an occlusive binder in accordance with FDRL Standard Operating Procedures.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Not applicable-UVCB

EC Number:

619-079-3

Cas Number:

949109-75-5

Molecular formula:

UVCB- Mixture of many formulae.

IUPAC Name:

Not applicable-UVCB

Test material form:

other: Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

4 hours

Observation period:

48 hours

Number of animals:

6

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4 and 48 hours

Score:

0

Max. score:

6

Reversibility:

other: Not irritating

Remarks on result:

other: Not irritating

Other effects:

No erythema, eschar formation or oedema was noted in any of the animals at the 4 and 48 hour observation periods. The mean primary skin irritation score (FHSA) is 0.00 Therefore, according to 16CFR 1500.3 Generol 122 is not considered to be a primary skin irritant.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: FHSA

Conclusions:

On the basis that no erythema or other effects were reported in the duration of the study it can be concluded that Generol 122 is not considered to be corrosive or irritating to the skin of rabbits.

Executive summary:

In a well conducted skin irritation study in rabbits, no erythema was noted in any of the test animals at the 4 and 48 hour observation periods. The mean primary skin irritation score (FHSA) is 0.00 Therefore, according to USA 16CFR 1500.3 the test substance is not considered to be irritating to skin.