L-Glutamic acid, N-coco acyl derivs., monosodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 October 1989 to 26 October 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

L-Glutamic acid, N-coco acyl derivs., monosodium salts

EC Number:

269-087-2

EC Name:

L-Glutamic acid, N-coco acyl derivs., monosodium salts

Cas Number:

68187-32-6

Molecular formula:

C17 H32 N1 O4 Na1

IUPAC Name:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.32 - 2.74 kg
- Housing: individually house in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14 - 20°C
- Humidity (%): 52 - 65%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent eye served as a control.

Amount / concentration applied:

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

Observation period (in vivo):

1h, 24h, 48h, 72h

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:

The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of opacity). For each tissue the total score was calculated as follows:

Total score for conjunctivae = (A + B + C) x 2
Total score for iris = D x 5
Total score for cornea = (E x F) x 5

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h, 48h, 72h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h, 48h, 72h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h, 48h, 72h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h, 48h, 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h, 48h, 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h, 48h, 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 14 days

Results 7

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h, 48h, 72h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h, 48h, 72h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 9

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h, 48h, 72h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h, 48h, 72h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h, 48h, 72h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h, 48h, 72h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 according to EU criteria

Conclusions:

Under the conditions of the study, the mean scores for cornea, conjunctiva, iris effects and chemosis were 1.8, 2.9, 1 and 2.4, respectively. All effects were reversible after 14 days. Consequently the test material is considered to be irritating to eyes.

Executive summary:

The test material was investigated for its eye irritation potential in accordance with the standardised guideline OECD 405, under GLP conditions.

During the study, a single instillation of the test material to the non-irrigated eye of three New Zealand White rabbits produced translucent or opalescent corneal opacity, iridial inflammation and severe conjunctival irritation. Other ocular effects noted were circumcorneal vascularisation, convoluted eyelids and dulling of the normal lustre of the corneal surface. The mean scores for cornea, conjunctiva, iris effects and chemosis were 1.8, 2.9, 1 and 2.4, respectively. All effects were reversible after 14 days. Consequently the test material is considered to be irritating to eyes.