Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977-08-24

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:

1977

Report date:

1977

Materials and methods

Principles of method if other than guideline:

The study was conducted in accordance with the techniques specified in the Regulations for the Enforcement of the Federal Hazardous Substances Act (Code of Federal Regulations, Title 16 Chapter II, 1976).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate

EC Number:

266-533-8

EC Name:

Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate

Cas Number:

66988-04-3

Molecular formula:

C24H44O6.Na

IUPAC Name:

sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate

Specific details on test material used for the study:

- Test material name: Pationic ISL
- Source: C.J. Patterson Company
- Appearance: Thick clear yellow liquid with a slight odor
- Batch No. : Pl 06 24 77

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

Up to 72 h

Observation period (in vivo):

24, 48 and 72 h

Number of animals or in vitro replicates:

6

Details on study design:

- For each sample, 0.1 mL of the undiluted test material was applied to the right eye of each of six New Zealand White rabbits from Sweetwater Farms. The opposite eyes were untreated and served as controls.
- Examinations for gross signs of eye irritation were made at 24, 48 and 72 h following application.
- Scoring of irritation effects was according to the method of Draize, in which corneal, iris and conjunctival effects are scored seperately.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.6

Max. score:

3

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.6

Max. score:

3

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.6

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.6

Max. score:

3

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

positive indication of irritation

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 14

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.6

Max. score:

3

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 16

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.6

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 17

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 18

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 19

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.6

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 20

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 21

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 22

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 23

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.6

Max. score:

3

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 24

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

- Irritative effects within 24 h following application included mild corneal opacity in 5 rabbits, mild iritis in three rabbits and mild to moderate conjunctivitis in all rabbits.
- By termination of the study, mild corneal opacity was noted in three rabbits, mild iritis was noted in three rabbits and mild to moderate conjunctivitis was observed in all six rabbits.

Any other information on results incl. tables

Table 1: Eye Irritation scores in albino rabbits following application of 0.1 mL of Pationic ISL.

Rabbit Number	Time (h)	Cornea		Iris	Conjunctivae			Total Score*
		Opacity	Area		Erythema	Swelling	Discharge
1	24	1	2	1	2	2	2	27
	48	1	1	1	3	1	2	22
	72	1	1	1	2	1	2	20
2	24	0	0	0	2	1	2	10
	48	0	0	0	2	1	1	8
	72	0	0	0	1	0	0	2
3	24	1	3	1	2	2	3	34
	48	1	2	1	2	1	3	27
	72	1	1	1	1	0	1	14
4	24	1	2	1	2	2	3	29
	48	1	2	1	3	1	1	25
	72	1	1	1	2	1	1	18
5	24	1	1	0	1	1	1	11
	48	0	0	0	1	0	0	2
	72	0	0	0	0	0	0	0
6	24	1	2	0	2	2	1	20
	48	0	0	0	2	1	1	8
	72	0	0	0	1	0	0	2

* Total score is the sum of the following 3 sub-totals: (a) degree of opacity x area involved x 5, (b) iris score x 5 and (c) sum of scores for erythema, swelling and discharge x 2

Total possible score = 110.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An in vivo eye irritation rabbit study of sodium isostearoyl lactylate showed mild eye irritant effects starting at 24 h after application of the substance. There was no increase in severity of the effects over the 72-h observation period, and the degree of corneal opacity and of conjunctival effects was reduced by 72 h in a number of rabbits. Based on these results and the GHS classification criteria for eye irritation, sodium isostearoyl lactylate does not warrant classification for eye irritation.

Executive summary:

In an in vivo eye irritation study, 6 New Zealand white rabbits were exposed to 0.1 mL of the test substance sodium isostearoyl lactylate (undiluted) and were observed 24, 48 and 72 h following application of the test substance. Mild irritative effects such as corneal opacity, iritis and conjunctivitis were observed in several rabbits within 24 h following application. Three out of six tested rabbits (i.e. 50%) exhibited corneal opacity as well as iritis with respective mean scores of 1 following grading at 24, 48 and 72 h after application. As for conjunctival redness (as reported as erythema in the study), two out of six tested rabbits (i.e. 33%) exhibited mean scores of 2 or higher, and no tested rabbits exhibited conjunctival oedema (as reported as swelling in the study) with a mean score of 2 or higher. There was no increase in severity of the effects over the 72-h observation period, and the degree of corneal opacity and of conjunctival effects was reduced by 72 h in a number of rabbits. Based on these results and the GHS classification criteria for eye irritation, sodium isostearoyl lactylate does not warrant classification for eye irritation.