Schiff bases, benzylidene, C16-18 (even numbered) and C18-unsaturated alkyl

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19th July 1982 - 6th August 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

The study was conducted in accordance with GLP and similar/equivalent OECD 404 guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Schiff bases, benzylidene, C16-18 (even numbered) and C18-unsaturated alkyl

Molecular formula:

Not applicable - UVCB

IUPAC Name:

Schiff bases, benzylidene, C16-18 (even numbered) and C18-unsaturated alkyl

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Rabbits were housed individually in cages sized in accordance with the Guide for the Care and use of Laboratory Animals of the Institute of Laboratory Animals of the Institue of Laboratory resources, Nationals Research Council. Waste Material was removed daily. Cages and feeders were sanitized every two weeks.Light cycle: 12hours light , 12 hours dark , Temperature/Humidity - every attempt was made to maintain a temperature of 20oC +/- 3 deg.Centigrade.and a humidity of 30-70%. Food and water was provided ad libitum and checked daily, added or replaced as required.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

Each rabbit was tested at two abraded and two intact sites.

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

O.5ml of the neat test material

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

6

Details on study design:

The skin of each 6 aldult albino rabbits were clipped free of furThe skin was abraded using a 21 guage butted needle. The abrassion penetrated the stratum corneum but not the derma. Following the application of the test material, one -inch square guaze patches were applied to each of the four sites the trunk of the animal was then wrapped with a rubber dam and an Ace bandage to retard evapouration. The test material was kept in contact with the skin for 24 hours. At the end of the 24hrs exposure period, the wrapping were removed and skin wiped to remove remaining test material.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/72 h

Score:

0.85

Max. score:

1

Reversibility:

fully reversible within:

Remarks:

14 days observation period

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24/72 h

Score:

0.925

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

14days observation period

Irritant / corrosive response data:

Individual animal scores are given below for 24 and 72 hours observations for the intact skin:

24hrs
Erythema Edema
Animal 1 1 0
Animal 2 1 1
Animal 3 1 1
Animal 4 1 0.5
Animal 5 1 1
Animal 6 1 1

72 hrs
Erythema Edema
Animal 1 0 1
Animal 2 1 1
Animal 3 1 2
Animal 4 0 1
Animal 5 1 1
Animal 6 1 1.5

14 days
Erythema Edema
Animal 1 0 0
Animal 2 0 0
Animal 3 0 0.5
Animal 4 0 0
Animal 5 0 0
Animal 6 0 0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The results from the study considers the test material to be Not irritating to skin. Therefore, in accordance with the criteria set in the CLP guidance document, the substance should not be classified for skin irritation.

Executive summary:

The test substance was assessed for dermal irritation effects on rabbit skin. Substance was applied intact and abraded skin site. Slight to very slight erythema and edema was observed within 24hours. At 72 hours, well defined edema was observed. Slight Erythema was observed on day 4 through day 13 of the study and slight edema was observed on day 4 through day 14 after treatment and the study was terminated on day 14. Therefore, based upon the observations made in the acute dermal irritation test in rabbits, the test substance was determined to be not irritating to the skin under CLP classification criteria.