N6-(1-oxododecyl)-L-lysine

Endpoint summary

Description of key information

Skin irritation

In the closed patch tests for these samples, slight erythema was observed in 2 animals, but it disappeared within 48 – 72 hours. The solvent olive oil also induced similar erythema in a closed patch test over 24 hours in half of the animals. These findings and the absence of concentration dependence of the sample suspension in olive oil suggest that erythema was associated not with the sample but with olive oil. In a closed patch test for 24 hours for the positive control moderate erythema and slight to moderate edema occurred, which showed no tendency to improve during the observation period of 8 days. Based on these results it was concluded that the test item had no irritant effect on the rabbit skin.

Eye irritation

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 light 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.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Draize test (24 hrs occlusive patch)

GLP compliance:

not specified

Specific details on test material used for the study:

not further specified

Species:

rabbit

Strain:

other: male white

Details on test animals or test system and environmental conditions:

Male white rabbits were purchased from Medical Experimental Animal Institute, and 6 healthy animals weighing 2.5 - 3.0 kg were selected among them. The chosen rabbits were each individually housed in stainless steel rabbit cages, in a room adjusted to temperature 22ºC ± 3ºC and humidity 50 ± 10% that was lighted for 8 hours/day by artificial illumination.
Feed was Oriental RC-4 pellets and tap water ad libitum.

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: olive oil

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

Test Material: 0.5 mL of a 5% or 20% solution in olive oil
Vehicle Material: 0.5 mL of olive oil
Positive Control: 0.5 mL of a 5% solution of SLS in water

Duration of treatment / exposure:

24 h

Observation period:

8 days

Number of animals:

6 per group

Details on study design:

Observation of general symptoms and determination of body weight were performed at 10 am everyday.

Irritation parameter:

overall irritation score

Basis:

mean

Remarks on result:

other: see below

Irritant / corrosive response data:

Oberservation period after treatment (h) 24 48 72 168
Mean score (20% suspension) 0.33 0.17 0.17 0
Mean score (5% suspension) 0.33 0.17 0 0
Mean score (vehicle) 0.5 0.33 0.17 0
Mean score (pos. controll) 4.5 4.67 4.5 5.17

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was judged as non-irritant to the rabbit skin.

Executive summary:

In the closed patch tests for these samples, slight erythema was observed in 2 animals, but it disappeared within 48 – 72 hours. The solvent olive oil also induced similar erythema in a closed patch test over 24 hours in half of the animals. These findings and the absence of concentration dependence of the sample suspension in olive oil suggest that erythema was associated not with the sample but with olive oil. In a closed patch test for 24 hours for the positive control moderate erythema and slight to moderate edema occurred, which showed no tendency to improve during the observation period of 8 days.

Based on these results it was concluded that the test item had no irritant effect on the rabbit skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

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

Specific details on test material used for the study:

not further specified

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.

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.

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The test item showed no significant skin and eye irritating potential in studies with experimental animals. Therefore, there is no need for classification and labelling of the test item according to CLP Regulation 1272/2008/EG.