Phytosteryl Macadamiate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-12-08 - 2000-06-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The GLP-study was conducted according an internationally accepted guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three New Zealand White rabbits supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK were used. At the start of the study the animals weighed 2.50 to 2.74 kg and were twelve to sixteen weeks old. After a minimum acclimatisation period of five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK) was allowed throughout the study.
The temperature and relative humidity were set to achieve limits of 17 to 23 °C and 30 to 70% respectively. Occasional deviations from these targets were considered not to have effected the purpose or integrity of the study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0,5 ml

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 h

Score:

1.3

Max. score:

8

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible

Any other information on results incl. tables

TABLE 1: INDIVIDUAL SKIN REACTIONS

Skin Reaction	Observation Time	Individual Scores-	Rabbit Number and Sex (Bodyweight kg)		Total
		147Male! (2 .74) .	127Male(2.50)	126Male(2.69)
	1Hour	0	0	0	(0 )
	24Hours	1	1	2	4
Erythema/Eschar Formation	48Hours	1	1	1	( 3 )
	72Hours	1Le	0	1Le	2
	7Days	0D	0D	0D	(0 )
	1Hour	0	o;	0	(0 )
	24Hours	0	1 !	1	2
Oedema Formation	48Hours	0	o	1	( 1 )
	72Hours	0	0	0	0
	7Days	0	0	0	(0)
Sum of 24 and 72-hour Readings (S)		8
Primary Irritation Index (S/6)		8/6 = 1.3
Classification		MILD IRRITANT

( ) = Total values not used for calculation of primary irritation index Le = loss of skin elasticity  D = slight desquamation

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material, YOFCO MAS LOT NO. 92506, produced a primary irritation index of 1.3 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight to well defined erythema and very slight oedema. Loss of skin elasticity and slight desquamation were also noted. No evidence of erythema or oedema was noted at the 7-day observation.

The test material produced a primary irritation index of 1.3 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.