Phytosteryl Macadamiate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-01-31 - 2000-06-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The GLP-study was performed according to 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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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 2.82 to 3.38 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 1 7 to 23 °C and 30 to 70% respectively. Occasional deviations from these targets were considered not to have affected 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

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 72 h

Score:

0

Max. score:

80

Reversibility:

not specified

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 72 h

Score:

0

Max. score:

10

Reversibility:

not specified

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 72 h

Score:

0

Max. score:

20

Reversibility:

not specified

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 72 h

Score:

0

Max. score:

80

Reversibility:

not specified

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 72 h

Score:

0

Max. score:

10

Reversibility:

not specified

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 72 h

Score:

0

Max. score:

20

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 72 h

Score:

0

Max. score:

80

Reversibility:

not specified

Results 8

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 72 h

Score:

0

Max. score:

10

Reversibility:

not specified

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 72 h

Score:

0

Max. score:

20

Reversibility:

not specified

Any other information on results incl. tables

Rabbit Number and Sex (Bodyweight kg)		Time After Treatment	Corneal Opacity	Iridial Inflammation	Conjunctival Redness	ConjunctivalChemosis
8Male		24 Hours	0	0	1	0
		48 Hours	0	0	0	0
(3.16)		72 Hours	0	0	0	0
	Total		0	0	1	0
	Mean		0.0	0.0 I	0.3	0.0
95Female		24 Hours	0	0	0	0
		48 Hours	0	0	0	0
(3.38)	I	72 Hours	0	0	0	0
	Total		0	1 0	0	0
	Mean		0.0	0.0	0.0	0.0
94Female		24 Hours	0	0	0	0
		48 Hours	0	0	0	0
(2.82)		72 Hours	0	0	0	0
	Total		0	0	0	0
	Mean		0.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material, YOFCO MAS LOT NO. 92506, produced a maximum group mean score of 6.0 and was classified as a MINIMAL IRRITANT (CLASS 3 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrase are therefore required.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method B5 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 instillation of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.

The test material produced a maximum group mean score of 6.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

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