Fatty acids, C14-18, C14-18-alkyl esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. Lack of detail on test material.

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:

lack of detail on test material.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C14-18, C14-18-alkyl esters

EC Number:

287-634-3

EC Name:

Fatty acids, C14-18, C14-18-alkyl esters

Cas Number:

85566-24-1

Molecular formula:

Not applicable as UVCB

IUPAC Name:

Fatty acids, C14-18, C14-18-alkyl esters

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:

unchanged (no vehicle)

Controls:

other: not required; the untreated eye served as control" in the remarks field

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

single application without washing

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 ( 3 males and 3 females)

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:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.1

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 9

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.23

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

In 2/6 animals no irritation was observed. However, in the other animals mild to moderate conjunctival irritation and/or corneal opacity was observed but was fully reversed within 72 h. Also, in 4/6 animals’ mild iritis was observed but was reserved within 24 h. (please see table 1 for more detail).

Any other information on results incl. tables

Table 1. Results of eye irritation study.

Rabbit #	Time [h]	conjunctivae		iris	cornea		conjunctivae		iris	cornea
		redness	swelling				redness	swelling
1
	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
2
	24	1	1	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0.3	0.0	0.0	Time to reversion	48.0	48.0	0.0	0.0
3
	24	1	2	1	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0.7	0.3	0.0	Time to reversion	48.0	48.0	48.0	0.0
4
	24	0	0	0	1
	48	0	0	0	1
	72	0	0	0	0
	average	0.0	0.0	0.0	0.7	Time to reversion	0.0	0.0	0.0	72.0
5
	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
6
	24	1	3	1	1
	48	1	0	0	1
	72	0	0	0	0
	average	0.7	1.0	0.3	0.7	Time to reversion	72.0	48.0	48.0	72.0
	Time [h]	conjunctivae		iris	cornea
		redness	swelling			avg. time to reversion	28.0	24.0	16.0	24.0
average score
	24	0.50	1.00	0.33	0.33
	48	0.17	0.00	0.00	0.33
	72	0.00	0.00	0.00	0.00
	24+48+72	0.67	1.00	0.33	0.66

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified