Fatty acids, C18-unsaturated, 2-hexyldecyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The analytical purity of the test substance was not reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Journal Officiel, 21.04.1971, amended on 05.06.1973

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted Oct 2012

Deviations:

yes

Remarks:

analytical purity not reported

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-octyldodecyl myristate

EC Number:

245-205-8

EC Name:

2-octyldodecyl myristate

Cas Number:

22766-83-2

Molecular formula:

C34H68O2

IUPAC Name:

2-octyldodecyl myristate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: the animals are housed individually in polystyrene cages (540 mm x 360 mm x 315 mm) with a perforated polystyrene floor
- Diet: 150 g complete maintenance food, granulés lapin Entretien '117' (UAR, Villemasson/Orgel, France)
- Water: softened and filtered drinking water, ad libitum
- Acclimation period: at least 8 days

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as the control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

Single instillation without rinsing

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48 and 72 h, and 4 and 7 days

Number of animals or in vitro replicates:

6 males

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: opthalmoscope; supplemetary assessments are performed using a hand-slit lamp, if necessary

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3 and #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #3, #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 8

Irritation parameter:

chemosis score

Basis:

animal: #3, #5 and #6

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 9

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

At the 1-h reading time point 6/6 rabbits had slight to moderate conjunctivae and chemosis (score 1 – 2), and effects on the iris (score 1). At the 24-h reading time point, slight conjunctivae (score 1) was observed in 1/6 rabbits, and slight chemosis (score 1) was seen in 4/6 other rabbits. Chemosis (score 1) was still present in 1/6 rabbits 48 h after instillation. Iris effects were observed in 2/6 animals at the 24-h reading time point, persisting in 1/6 until 48 h after instillation. All eye irritation effects had cleared completely within 72 h. No cornea opacity was observed in any rabbit at any time point (see Table 1).

Any other information on results incl. tables

Table 1. Individual eye irritation scores

Rabbit #	Time	conjunctivae		iris	cornea
		redness	swelling
1	1 h	1	1	1	0
	24 h	0	0	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.0	0.0	0.0
2	1 h	1	2	1	0
	24 h	1	0	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.33	0.0	0.0	0.0
3	1 h	2	2	1	0
	24 h	0	1	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.33	0.0	0.0
4	1 h	2	2	1	0
	24 h	0	1	1	0
	48 h	0	0	1	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.33	0.67	0.0
5	1 h	2	2	1	0
	24 h	0	1	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.33	0.0	0.0
6	1 h	1	2	1	0
	24 h	0	1	1	0
	48 h	0	1	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.67	0.33	0.0

*(24h+48h+72h)/3

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.