N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 September, 2003 - 28 September, 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1992)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

(1992)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

451-060-3

EC Name:

-

Cas Number:

122886-55-9

Molecular formula:

C31H48N4O2

IUPAC Name:

3-octyl-1-[4-({4-[(octylcarbamoyl)amino]phenyl}methyl)phenyl]urea

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): KY-UN
- Stability under test conditions: not stated
- Storage condition of test material: at room temperature and protected from light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 3.1 ± 0.1 kg
- Housing: Animals were housed individually in polystyrene cages.
- Diet: Free access to 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water: Free access to drinking water filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: The test substance was moistened with purified water

Controls:

other: Adjacent areas of the untreated skin of each animal served as controls.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 grams

VEHICLE
The test substance was moistened with purified water.

Duration of treatment / exposure:

Single application. 3 minutes; 4 hours

Observation period:

4 days.

Number of animals:

3 (male/female)

Details on study design:

STUDY DESIGN
The day before treatment, both flanks of each animal were clipped using electric clippers and the skin of each animal was examined in order to check the absence of any signs of skin irritation. Clipping was repeated thereafter on days 1 and 2 for 2 animals and on day 3 for 2 animals.
As possible irritant effects were anticipated, the test item was evaluated on a single animal in the first instance. The duration of exposure was 3 minutes on one flank and 4 hours on the other flank. Since the test item was not irritant on this first animal, it was then applied for 4 hours to two other animals.

TEST SUBSTANCE PREPARATION
The test substance was applied in its original form.

REMOVAL OF TEST SUBSTANCE
After removal of the dressing, any residual test item was wiped off by means of a moistened cotton pad.

OBSERVATIONS
- Irritation:
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

In the first animal (3 minute exposure), no reactions were observed.
A very slight erythema (grade 1) was noted in 1 animal, at the 1-hour reading only. No other cutaneous reactions were noted during the study.

Applicant's summary and conclusion

Interpretation of results:

other: Not skin irritating

Remarks:

According to Regulation (EC) No 1272/2008 and its amendments.

Conclusions:

In a skin irritation study with rabbits, performed according to OECD 404 test guideline and GLP principles, no irritation was observed.

Executive summary:

KY-UN was tested in a skin irritation study with rabbits, performed according to OECD 404 test guideline and GLP principles.

In the first animal (3 minute exposure), no reactions were observed. Since the test item was not irritant on this first animal, the test substance was applied for 4 hours to two other animals.

A very slight erythema (grade 1) was noted in 1 animal, at the 1-hour reading only. No other cutaneous reactions were noted during the study. Based on the results KY-UN does not have to be classified for skin irritation according to Regulation (EC) No 1272/2008.