1-[4-[[2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,6-dihydroxyphenyl]-3-(3-hydroxy-4-methoxyphenyl)propan-1-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

0.1mL dose, treated eyes unwashed for 24h, 7d observation period.

Principles of method if other than guideline:

The procedure followed was a modification of that used by Dr. J.H. Draize in Appraisal of The Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration - Department of Health, Education and Welfare.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-[4-[[2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,6-dihydroxyphenyl]-3-(3-hydroxy-4-methoxyphenyl)propan-1-one

EC Number:

243-978-6

EC Name:

1-[4-[[2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,6-dihydroxyphenyl]-3-(3-hydroxy-4-methoxyphenyl)propan-1-one

Cas Number:

20702-77-6

Molecular formula:

C28H36O15

IUPAC Name:

1-[4-[[2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,6-dihydroxyphenyl]-3-(3-hydroxy-4-methoxyphenyl)propan-1-one

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Neo-DHC, Lot #26-RS-17, received date 8/11/78.
- Purity (HPLC): 98.5%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Six albino New Zealand rabbits (3 males, 3 females), healthy, without ocular defects; no further details.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1mL

Duration of treatment / exposure:

24h.

Observation period (in vivo):

7d.

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: water rinsing.
- Time after start of exposure: 24h.

SCORING SYSTEM: Observations of injuries were made on the cornea, iris and the bulbar and palpebral conjunctivae. Numerical scores were assigned to lesions observed according to the Draize standard scoring system. In this system, the injuries to the cornea and iris account for approximately 80% of the total score; these structures are purposely weighted because of their vital role in the vision. The maximum score is the sum of all scores obtained for the cornea, iris, and conjunctivae.

TOOL USED TO ASSESS SCORE: hand-held lenses.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

2.2

Max. score:

110

Reversibility:

fully reversible within: 2d

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

110

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

110

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: one animal, at 72 h showed signs (see the tabe 1 below).

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: one animal at 72 h and 5d showed signs (see the table 1 below).

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: no information on chemosis is given.

Irritant / corrosive response data:

See table 1.

Any other information on results incl. tables

Table 1. Eye Irritation

Rabbit	Day	Cornea A x B x 5		Iris C x 5	Conjunctivae (D + E + F) x 2			Total Score
1	1	0	0	0	0	0	0	0
	2	0	0	0	0	0	0	0
	3	0	0	0	0	0	0	0
	4	-	-	-	-	-	-	-
	7	-	-	-	-	-	-	-
2	1	0	0	0	0	0	0	0
	2	0	0	0	0	0	0	0
	3	0	0	0	0	0	0	0
	4	-	-	-	-	-	-	-
	7	-	-	-	-	-	-	-
3	1	0	0	1	1	1	1	11
	2	0	0	0	1	0	0	2
	3	0	0	0	0	0	0	0
	4	-	-	-	-	-	-	-
	7	-	-	-	-	-	-	-
4	1	0	0	0	0	0	0	0
	2	0	0	0	0	0	0	0
	3	0	0	0	0	0	0	0
	4	-	-	-	-	-	-	-
	7	-	-	-	-	-	-	-
5	1	0	0	0	1	0	0	2
	2	0	0	0	0	0	0	0
	3	0	0	0	0	0	0	0
	4	-	-	-	-	-	-	-
	7	-	-	-	-	-	-	-
6	1	0	0	0	0	0	0	0
	2	0	0	0	0	0	0	0
	3	0	0	0	0	0	0	0
	4	-	-	-	-	-	-	-
	7	-	-	-	-	-	-	-
Average	1	*total score possible = 110						2.2
	2							0.3
	3							0.0
	4							-
	7							-

A: opacity, B: area of cornea involved, C: value, D: redness, E: chemosis, F: discharge.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

EU criteria

Conclusions:

Under test conditions, the test substance is found to be not irritating.

Executive summary:

A study to investigate possible irritation or corrosion of the test substance on the eyes of rabbits was performed according to Draize (1944), similar to OECD Guideline 405 (no GLP). The right eye of 6 New Zealand White rabbits (3 males, 3 females) received single application of 0.1ml test item, while the left eye was used as a control. The treated eyes of all rabbits remained unwashed for 24h, readings were made using hand-held lenses 1, 2, 3 and up to 7 days after. Under test conditions, the test substance was found to be non-irritating to the eyes.