N6-(1-oxododecyl)-L-lysine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Draize test

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N6-(1-oxododecyl)-L-lysine

EC Number:

257-843-4

EC Name:

N6-(1-oxododecyl)-L-lysine

Cas Number:

52315-75-0

Molecular formula:

C18H36N2O3

IUPAC Name:

N6-(1-oxododecyl)-L-lysine

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

not further specified

Test animals / tissue source

Species:

rabbit

Strain:

other: male white

Details on test animals or tissues and environmental conditions:

Male white rabbits were purchased from Medical Experimental Animal Institute.
12 healthy animals weighing 2.0 - 2.5 kg were used for the study.
The rabbits were each individually housed in stainless steel rabbit cages.
Temperature: 22+/-3ºC.
Humidity: 50+/-10%.
8 hours/day lighted by artificial illumination.
Oriental RC-4 pellets and tap water ad libitum.

Test system

Vehicle:

other: olive oil

Controls:

yes, concurrent positive control

Amount / concentration applied:

0.1 mL of a 20% solution of the test item

Duration of treatment / exposure:

see below

Observation period (in vivo):

up to 192 h

Number of animals or in vitro replicates:

6 per group

Details on study design:

The animals were macroscopically confirmed by use of a slip lamp on the day just before the test to have no abnormalities in either eye, then 0.1 mL of 2% sodium fluorescein solution in water was instilled into the eyes, and the eyes were immediately washed with 20 ml of lukewarm water to verify that the cornea was not injured.
On the next day, 0.1 mL of the test sample was instilled into one eye (right) with the lower lid formed into a pocket, and retained there by closure of upper and lower lids for 1 minute to allow the test sample to be dispersed over the whole eyeball, in each of 6 animals per sample. Three of these 6 animals remained with the eyes closed and unwashed, while the remaining 3 animals had their eyes washed with 20 mL of purified lukewarm water at several seconds after instillation of the sample.
The animals were immobilized in stocks for 3 hours after sample instillation, and returned to the cage one by one.
At 24, 48 and 72 hours and 8 days after sample instillation, the reaction in the conjunctive, cornea and iris were scored according to the Draize system with the left eye as control. A slit lamp for ophthalmoscopy was used for observation, and photographs were taken at 24, 72 hours and 8 days after sample instillation.
Observation of general symptoms and determination of body weight were performed at 10 a.m. everyday.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Remarks:

not rinsed

Basis:

mean

Time point:

24 h

Score:

2

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

overall irritation score

Remarks:

not rinsed

Basis:

mean

Time point:

48 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

overall irritation score

Remarks:

rinsed

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Conclusions:

It can be concluded that the test item has nearly no irritating potential for the rabbit eye mucosa.

Executive summary:

The test sample was prepared as a 20% suspension in olive oil because it is not soluble in water. When it was instilled in the eye, the aforesaid results were obtained. Namely, no symptoms were observed in the unwashed eyes except for slight redness in the conjunctiva 24 hours after instillation, with the complete disappearance of symptoms at 48 hours. In the washed eyes, no irritative symptoms occurred. It seemed reasonable to attribute redness in the unwashed eyes to the solvent olive oil.

In the positive control group (5% solution of SLS in water) moderate irritation was detected.

From the above results it can be concluded that the test item has nearly no irritating potential for the rabbit eye mucosa.