D-Xylopyranose, oligomeric, 2-octyldodecyl xylosides

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

APX 20P

IUPAC Name:

APX 20P

Details on test material:

Sponsors identification : APX 20 P
Description : brown paste
Batch number : 270 LG
Date received : 12 December 2002
Storage conditions : room temperature in the dark

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch No. 270 LG
- Expiration date of the lot/batch: 28/08/2003

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The tst iteme was stored at room temperature in the dark

FORM AS APPLIED IN THE TEST (if different from that of starting material)
- For the purpose of the study the test item was used as supplied.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three New Zealand White rabbits were supplied by David Percivai Ltd, Moston, Sandbach, Cheshire, UK. At the start of the study the animais were in the weight range of 2.0 to 3.5 kg and were tweive to twenty weeks oid. After an acclimatisation period of at ieast 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 ofthe ear and on the cage label.
The animais were individualiy housed in suspended metal cages. Free access to mains drinking water and food (Certified Rabbit Diet (Code 5322) suppiied by International Product Supplies Limited, Wellingborough, Northants, UK) was ailowed throughout the study. The diet and drinking water were considered flot to contain any contaminant of a level that might have affected the purpose or integrity ofthe study.

The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered flot to have affected the purpose or integrity of the study. The rate of air exchange was at ieast fifieen changes per hour and the lighting was controlled by a time switch to give tweive hours continuous light (06:00 to 18:00) and twelve hours darkness.

The animais were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye

Amount / concentration applied:

0.1 mL

Observation period (in vivo):

1 hour, 24, 48 and 72 hours following treatment

Number of animals or in vitro replicates:

3

Details on study design:

Immediately before the start of the test, both eyes of the provisionaily seiected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Oniy animais free of ocuiar damage were used.
Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately afier administration of the test material, an assessment of the initial pain reaction was made according to the six point scale shown in Appendix 1.
After consideration of the ocular responses produced in the first treated animal, two additional animais were treated.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix 2, (from Draize J H (1977) “Dermal and Eye Toxicity Tests” In: Principles and Procedures for Evaluating the Toxicity ofHousehold Substances, National Academy of Sciences, Washington DC p.48 to 49).
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.3

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

1

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0.3

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.3

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0.7

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

ca. 0

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

ca. 0

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

ca. 0

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

ca. 0

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

ca. 0

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

ca. 0

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

ca. 0

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 3 days

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material produced a maximum group mean score of 8.7 and was classified as a
MILD IRRITANT (CLASS 4 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified
Kay and Calandra classification system.
The test material did flot meet the criteria for classification as irritant according to EU labeiling regulations Commission Directive 200 1/59/EC.

Executive summary:

Introduction.

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye IrritationlCorrosion” (adopted 24 April 2002)

• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)

Result.

A single application of the test material to the non-irrigated eye of tbree rabbits produced minimal to moderate conjunctival irritation. Two treated eyes appeared normal at the 48-hour observation and the remaining treated eye appeared normal at the 72-hour observation.

Conclusion.

The test material produced a maximum group mean score of 8.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did flot meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/5 9/EC.