Fatty acids, C14-22, C16-24-alkyl esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 - 31 Jan 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

limited documentation; no analytical purity of test substance given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted Oct 2012

Deviations:

yes

Remarks:

limited documentation; no analytical purity of test substance given

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16 and C18-22-unsatd., C16-18 and C18-unsatd. alkyl esters

EC Number:

292-792-1

EC Name:

Fatty acids, C16 and C18-22-unsatd., C16-18 and C18-unsatd. alkyl esters

Cas Number:

90990-29-7

Molecular formula:

not applicable, substance is UVCB

IUPAC Name:

Fatty acids, C16 and C18-22 - unsatd., C16-18 and C18 unsatd. alkyl ester

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Nottingham, UK
- Weight at study initiation: 2.00 - 2.42 kg (range: males and females)
- Housing: individually in suspended metal cages
- Diet: rabbit diet (J. Waring (Feeds) Limited, Shardlow, Derbyshire, UK), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Air changes (per hr): at least 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye remained untreated and served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

72 h
Reading time points: 24, 48 and 72 h

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: ophthalmoscope; Observation of corneal opacity was carried out under ultra-violet illumination preceded by the instillation of fluorescein into the eye.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 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:

of 6 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, #4 and #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #2, #3 and #6

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #2, #3, #4 and #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

3/6 animals showed conjunctival redness (score 1) 24 and 48 h after instillation, reversible within 72 h. 2/6 animals showed conjunctivae chemosis (score 1) 24 h after instillation of test substance, in one animal reversible within 48 h, in the second animal reversible within 72 h.

Any other information on results incl. tables

Table 1. Results of eye irritation study.

Alteration	Animal No.	Time (h)
		24	48	72	mean 24/48/72 h	reversible within
Cornea	1	0	0	0	0	-
	2	0	0	0	0	-
	3	0	0	0	0	-
	4	0	0	0	0	-
	5	0	0	0	0	-
	6	0	0	0	0	-
Iris	1	0	0	0	0	-
	2	0	0	0	0	-
	3	0	0	0	0	-
	4	0	0	0	0	-
	5	0	0	0	0	-
	6	0	0	0	0	-
Conjunctivae Redness	1	0	0	0	0	-
	2	1	1	0	0.67	72 h
	3	1	1	0	0.67	72 h
	4	0	0	0	0	-
	5	0	0	0	0	-
	6	1	1	0	0.67	72 h
Conjunctivae Chemosis	1	1	1	0	0.67	72 h
	2	0	0	0	0	-
	3	0	0	0	0	-
	4	0	0	0	0	-
	5	0	0	0	0	-
	6	1	0	0	0.33	48 h

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.