Fatty acids, C18 unsaturated, C12-14 (even numbered) alkyl esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

; purity not reported, 50% dilution of test substance

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3234-85-3 (50% dilution)

IUPAC Name:

3234-85-3 (50% dilution)

Details on test material:

- Name of test material (as cited in study report): [only trade name given]
- Analytical purity: no data

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: 1.8-2.4 kg

Test system

Vehicle:

other: corn oil

Controls:

other: the left eye served as the control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 50% (w/w)

VEHICLE
- Concentration (if solution): 50% (w/w)

Duration of treatment / exposure:

Single application without washing

Observation period (in vivo):

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

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed after instillation.

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-held lens

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

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 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Results 9

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

Slight redness was observed in 4/6 animals at the 24-hour reading time point, which had cleared completely within 72 hours (see Table 1). No other eye irritation effects were observed in any of the animals.

Any other information on results incl. tables

Table 1: Individual eye irritation scores

 

Rabbit #	Time [h]	conjunctivae		iris	cornea		conjunctivae		iris	cornea
		redness	swelling				redness	swelling
1
	24	1	0	0	0
	48	1	0	0	0
	72	0	0	0	0
	average	0.67	0.0	0.0	0.0	Time to reversion	72.0	0.0	0.0	0.0
2
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33	0.0	0.0	0.0	Time to reversion	48.0	0.0	0.0	0.0
3
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.0	0.0	0.0	0.0	Time to reversion	0.0	0.0	0.0	0.0
4
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33	0.0	0.0	0.0	Time to reversion	48.0	0.0	0.0	0.0
5
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33	0.0	0.0	0.0	Time to reversion	48.0	0.0	0.0	0.0
6
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.0	0.0	0.0	0.0	Time to reversion	0.0	0.0	0.0	0.0
	Time [h]	conjunctivae		iris	cornea
		redness	swelling			avg. time to reversion	36.0	0.0	0.0	0.0
average score
	24	0.67	0.00	0.00	0.00
	48	0.17	0.00	0.00	0.00
	72	0.00	0.00	0.00	0.00
	24+48+72	0.28	0.00	0.00	0.00

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

not irritating to the eyes

Executive summary:

An in vivo eye irritation study in rabbits was perfromed with tetradecyl myristate (CAS No. 3234 -85 -3), a constituent of the registration substance. Mean scores for cornea, iris, conjunctiva redness and chemosis for all 6 animals after 24, 48, and 72 hours were 0, 0 and in the range of 0.33 to 0.66. All effects were fully reversible within 72 h. Thus, the substance does not have to be classified according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).