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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 - 28 Feb 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted Feb 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

EEC Directive 92/69/EEC, Dez 1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

(SPF)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Broekman Instituute B.V., Someren, Netherlands
- Age at study initiation: 8, 17 or 18 weeks
- Housing: individually in cages with perforated floors
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, Netherlands), approx. 100 g per day; hay (BMI, Helmond, Netherlands) once a week
- Water: tap water diluted with decalcified water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- 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: 63.9 ± 2.6 mg (approx. 0.1 mL)

Duration of treatment / exposure:

single treatment without washing

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3 males

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

OBSERVATIONS: Animlas were observed for mortality/viability twice daily and for signs of toxicity at least once a day. Body weight was determined on the day of treatment prior to instillation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48

Irritant / corrosive response data:

Iridic irritation grade 1 was observed in one animal 1 hour after instillation. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 72 hours in one animal and within 7 days in the other two animals. No corneal opacity or corneal epithelial damage was observed in any of the animals.

Other effects:

- Other observations: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1. Results of eye irritation test

Alteration	Animal No.	Time (h)
		24	48	72	mean 24/48/72 h	reversible within
Cornea	1	0	0	0	0.0	n.a.
	2	0	0	0	0.0	n.a.
	3	0	0	0	0.0	n.a.
Iris	1	0	0	0	0.0	n.a.
	2	0	0	0	0.0	n.a.
	3	0	0	0	0.0	n.a.
Conjunctivae Redness	1	2	1	1	1.3	7 d
	2	1	1	0	0.7	72 h
	3	2	2	1	1.7	7 d
Conjunctivae Chemosis	1	1	0	0	0.3	48 h
	2	1	0	0	0.3	48 h
	3	1	0	0	0.3	48 h

n.a.: not applicable

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.