Fatty acids C16-18 (even numbered), mono and di esters with Sucrose

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

21 May - 11 Jun 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted Feb 24, 1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids C16-18 (even numbered), mono and di esters with Sucrose

EC Number:

947-854-9

Molecular formula:

not applicable, substance is UVCB

IUPAC Name:

Fatty acids C16-18 (even numbered), mono and di esters with Sucrose

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

Chbb:NZW (SPF)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae, Biberach, Germany
- Weight at study initiation: 2.7 - 3.2 kg
- Housing: individually
- Diet: ssniff® K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C.
- Time after start of exposure: 24 h after exposure and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of 2 animals

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

One hour up to 3 days after application the conjunctivae of the animals showed an evident hyperaemia of the blood vessels to a diffuse beefy red and a swelling with lids about half closed. The iris was reddened in 2/3 animals. Diffuse to translucent areas of the cornea were observed in the animals one day up to 3 days after application. In addition a clear colourless or white-yellowish viscous discharge and blanched nictating membrane occurred in the animals. 7 days after application no more signs were seen, indicating full reversibility.

Any other information on results incl. tables

Table 1. Results of the eye irritation study

Alteration	Animal No.	Time (h)
		24	48	72	mean 24/48/72 h	reversible within
Cornea	1	2	2	2	2.0	7 days
	2	1	0	0	0.3	48 h
	3	2	1	1	1.3	7 days
Iris	1	1	1	1	1.0	7 days
	2	1	0	0	0.3	48 h
	3	0	0	0	0.0	n.a.
Conjunctivae Redness	1	3	3	2	2.7	7 days
	2	3	3	1	2.3	7 days
	3	3	3	2	2.7	7 days
Conjunctivae Chemosis	1	3	0	0	1.0	72 h
	2	2	1	0	1.0	72 h
	3	2	1	0	1.0	72 h

Applicant's summary and conclusion

Interpretation of results:

other: Eye Irrit. 2 according to Regulation (EC) 1272/2008

Conclusions:

Under the conditions of this eye irritation study in rabbits the test substance was irritating to the eye.