Reaction products of behenic acid, Eicosadioic acid and Polyglyceryl-10

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19. June - 23 June 2000 (experimental interval)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

This test was designed to detennine the ocular irritation potential of substances in the non-rinsed
eyes of three (3) rabbits. The procedure is a modification of that desciibed by J.H. Draize (J.H. Draize, "Deimal Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and
Cosmetics, (The Association of Food and Drug Officials of the United States, 1959), pp. 49 - 51.). This protocol was designed to satisfy the requirements of the Japanese Ministry of Health and
Welfare.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

478-920-0

EC Name:

-

Cas Number:

457632-32-5

Molecular formula:

C22H44O2.4 C20H38O4.1 (C3H8O3).20

IUPAC Name:

1,20-bis({3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]-2-hydroxypropyl}) icosanedioate

Test material form:

solid: pellets

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0-3-A
- Expiration date of the lot/batch: not stated
- Purity test date: not stated


RADIOLABELLING INFORMATION (if applicable)
not applicabble

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not stated
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
not stated

Test Article is described as liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three (3), female, New Zealand white rabbits weighing approximately two (2) kilograms and
about three (3) months of age, were used for each test atiicle. The animals were obtained
through a suitably licensed dealer. The animals were checked carefully upon receipt for ocular
defects, diarrhea and dehydration, respiratory difficulties, postural deficiencies, and general
condition. Any animal exhibiting visible ocular defects or irritation, or poor condition, was
rejected.
The animals were acclimated for five (5) days prior to test initiation. They were individually
housed in stainless steel cages, in a temperature controlled room, with a 12 hour light/dark cycle
and identified through individual markings on the outer ear of each animal, as well as a cage
label. The room temperature was controlled to comply with Animal Welfare Regulations with an
approximate range of 65° to 15° F. The humidlity was also monitored. Diet consisted of Lab
Diet Certified Rabbit Diet #5322, at 100 grams per day per animal. Water was provided ad
libitum.

Test system

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.1 ml of 20 % solution.

Duration of treatment / exposure:

24 hour before washing

Observation period (in vivo):

at 1, 24, 48 and 72 hours

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): if necessary, washing is done after 24 hours
- Time after start of exposure: 24 hours

SCORING SYSTEM:

comparable to Guideline:
A Opacity (0-4)
B Area of Cornea involved (0-4)
C Iris (0-2)
D Conjunctivae Redness (0-3)
E Conjunctivae Chemosis (0-4)
F Conjunctivae Discharge (0-3)

Total score = (A*B*5)+(C*5)+((A+B+C)*2) = 110

TOOL USED TO ASSESS SCORE: not stated

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

110

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

two animals showed in the course of the study mild redness of the conjunctivae (score 1). No other signs of irritation were noted.

Other effects:

no other effects noted

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this test, Nomcort HK-P elicited mild, reversible, conjunctival initation to the eyes of rabbits. However the effects are not sufficient for meeting the classification criteria.

Executive summary:

Three (3) New Zealand white rabbits, free from visible ocular defects, each

received a single intraocular application of one-tenth of one milliliter (0.1 ml) of

the test article in one (1) eye. The contralateral eye, remaining untreated, served as

a control. The eyes of all animals remained unwashed for 24 hours. Observations

of corneal opacity, iritis, and conjunctivitis were recorded one (1), 24, 48, and 72

hours after treatment, and at four (4) and seven (7) days, if initation persisted. The

test article was uJed as a 20% suspension in distilled water, that had been heated at

approximately 70° C for 30 minutes. The mixture was allowed to cool prior to

dosing.

--------Average Draize Scores--------

Hours                                                  Days

1       24       48       72       4       7

Unwashed 2.0   0.7 0.7 0.7 0.0 -

Conclusion: Under the conditions of this test, this test article elicited mild, reversible,

conjunctival initation to the eyes of rabbits.