N6-(1-oxododecyl)-L-lysine

Skin irritation / corrosion

Administrative data

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

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 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Draize test (24 hrs occlusive patch)

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

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.

Test system

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.

Results and discussion

In vivo

Results

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

Applicant's summary and conclusion

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.