Potassium (2S)-4-carboxy-2-(tetradecanoylamino)butanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 April 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

potassium (2S)-4-carboxy-2-tetradecanamidobutanoate

EC Number:

700-938-7

Cas Number:

72716-26-8

Molecular formula:

C19H34NO5K

IUPAC Name:

potassium (2S)-4-carboxy-2-tetradecanamidobutanoate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: White to pale yellow powder, slightly characteristic odour.
- Storage condition of test material: Room temperature.

Test animals / tissue source

Species:

chicken

Strain:

other: Ross 308

Details on test animals or tissues and environmental conditions:

Eye Samples:
- Species of chicken: Ross 308.
- Source: Taravis KFT. 9600 Sárvár, Rábasömjéni út. 129.
- Method: Chicken heads were collected after slaughter in a commercial abattoir from chickens which are used for human consumption. Heads were transported at ambient temperature. After collection, the heads were inspected for appropriate quality and wrapped with tissue paper moistened with saline, then stored in a closed plastic box (4-5 heads per box).

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 mg

Duration of treatment / exposure:

Single application, removed after 10 seconds.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Run / experiment:

mean

Value:

2

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation parameter:

fluorescein retention score

Run / experiment:

mean

Value:

2

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Results 3

Irritation parameter:

percent corneal swelling

Run / experiment:

mean up to 75 minutes

Value:

1

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Results 4

Irritation parameter:

percent corneal swelling

Run / experiment:

mean up to 240 minutes

Value:

1

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The results suggest that the test material is moderately irritating but not a severe irritant.

Controls:
The positive control imidazole was classed as severely irritating.
The negative control Sodium chloride (Salsol solution 0.9%) had no significant effects on the chicken eye in this study.

Any other information on results incl. tables

Table 4: Test Material Results 

Observations	Value	ICE Class
Mean maximum corneal swelling at up to 75 min	1 %	I
Mean maximum corneal swelling at up to 240 min	1 %	I
Mean maximum corneal opacity	2.00	III
Mean fluorescein retention	2.00	III
Other Observations	The test material was stuck on the cornea surface after the post-treatment rinse. All corneal surfaces were cleared 75 minutes after the post-treatment rinse.
Overall ICE Class	1 x I, 2 x III

Table 5: Positive Control Results

Observations	Value	ICE Class
Mean maximum corneal swelling at up to 75 min	3 %	I
Mean maximum corneal swelling at up to 240 min	8 %	II
Mean maximum corneal opacity	4.00	IV
Mean fluorescein retention	2.83	IV
Other Observations	The Imidazole was stuck on the cornea surface after the post treatment rinse. The cornea surface was not cleared 240 minutes after the post-treatment rinse.
Overall ICE Class	1 x II 2 x IV

 

Table 6: Negative Control Results

Observations	Value	ICE Class
Mean maximum corneal swelling at up to 75 min	0 %	I
Mean maximum corneal swelling at up to 240 min	0 %	I
Mean maximum corneal opacity	0.00	I
Mean fluorescein retention	0.00	I
Other Observations	None
Overall ICE Class	3 x I

Applicant's summary and conclusion

Interpretation of results:

other: not irritating according to EU criteria

Conclusions:

Under the conditions of the test, the results suggest that the test material is moderately irritating.

Executive summary:

An in vitro eye irritation study in isolated chicken eyes was conducted under GLP conditions and according to the OECD guideline 438 and EU Method B.48 to determine if the test material caused corrosion or severe eye irritation. Three chicken eyes were exposed to the test material (30 mg) for 10 seconds, rinsed with isotonic saline, and then assessed for irritation at intervals for up to 240 minutes. Toxic effects to the cornea were measured by a qualitative assessment of opacity, damage to epithelium based on application of fluorescein to the eye (fluorescein retention), and measurement of cornea thickness (swelling). Damage was assessed individually and then combined to derive an Eye Irritancy Classification. Positive and negative controls were run concurrently to assess the viability of the test system.

Under the conditions of the study, exposure to the test material resulted in an overall ICE class of 1 x I and 2 x III, which corresponds to a classification of moderately irritating in accordance with the OECD guideline. The results suggest that the test material is moderately irritating, but should not be classified as a severe eye irritant.