Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: US-EPA § 163.81-4, “Primary eye irritation study”, Federal Register, Vol 43, No. 163, August 22, 1978

Deviations:

yes

Remarks:

lack of test material details, observation period only 7 days

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine

EC Number:

203-749-3

EC Name:

(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine

Cas Number:

110-25-8

Molecular formula:

C21H39NO3

IUPAC Name:

N-methyl-N-oleoylglycine

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: 2-3 kg
- Housing: animals were housed individually in metal cages
- Diet: standard rabbit food - NAFAG, No. 814 (Gossau SG), ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10/10

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7days
Reading time points:
1, 2, 3, 4 and 7 days

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: in 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline.
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Draize scoring system and primary irritation index

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

1.11

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals without rinsing

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

2.78

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Irritant / corrosive response data:

The individual results of the eye irritation test after 24, 48 and 72 h are listed in Table 1. In general, rinsing of the eye following instillation was of low or no effect (see Table 1 under "Any other information on results incl. tables").
Cornea: After 4 days scattered or diffuse area in 3/6 animals and easily discernible translucent areas 3/3 animals were observed. After 7 days 2/6 animals showed scattered or diffuse area and 4/6 animals showed easily discernible translucent areas.
Iris: After 4 days 1/6 animals and after 7 days 2/6 animals (all from the group without rinsing) showed folds above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof) iris still reacting to light.
Conjunctivae:Redness: All animals showed diffuse beefy redness after 4 and 7 days. After 4 days obvious swelling with partial eversion of lids was observed in 4/6 animals and swelling with lids about half closed in 2/6 animals (group without rinsing). After 7 days in all animals obvious swelling with partial eversion of lids was still apparent.
Discharge: After 4 days, discharge with moistening of the lids and hairs just adjacent to lids was observed in 4/6 animals, discharge with moistening of the lids and hairs, and considerable area around the eye was observed in 1 animal of the group without rinsing. In 1 animal (rinsing group) only slight discharge was observed. After 7 days, 2/6 animals showed slight discharge, and 3/6 animals still moderate and 1 animal (without rinsing group) discharge with moistening of the lids and hairs, and considerable area around the eye.

Other effects:

No further local or systemic effects were reported.

Any other information on results incl. tables

Table 1. Results of eye irritation study.

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
407 not rinsed	24	3	3	0	1
	48	3	3	0	1
	72	3	3	0	1
	average	3,0	3,0	0,0	1,0
408 not rinsed	24	3	3	0	1
	48	3	4	0	1
	72	3	4	0	0
	average	3,0	3,7	0,0	0,7
409 not rinsed	24	3	3	0	1
	48	3	3	0	1
	72	3	3	0	2
	average	3,0	3,0	0,0	1,3
410 rinsed	24	3	3	0	1
	48	3	2	0	1
	72	3	2	0	2
	average	3,0	2,3	0,0	1,3
411 rinsed	24	3	3	0	1
	48	3	2	0	1
	72	3	2	0	1
	average	3,0	2,3	0,0	1,0
412 rinsed	24	3	3	0	1
	48	3	2	0	1
	72	3	2	0	2
	average	3,0	2,3	0,0	1,3
	Time [h]	conjunctivae		Iris	cornea
		redness	swelling
average score	24	3,00	3,00	0,00	1,00
	48	3,00	2,67	0,00	1,00
	72	3,00	2,67	0,00	1,33
	24+48+72	3,00	2,78	0,00	1,11

Applicant's summary and conclusion

Interpretation of results:

other: Eye damage 1, H318. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS).

Conclusions:

In the present study irreversible effects within a shorter observation period were observed in all animals. Classification as Category 1 was based on an expert judgement considering a worst case assumption.