N,N''-(methylenedi-4,1-phenylene)bis[N'-cyclohexylurea];N-(4-[[4-[[(phenylamino)carbonyl]amino]phenylmethyl]phenyl]-N'-cyclohexylurea;reaction mass of: N,N''-(methylenedi-4,1-phenylene)bis[N'-phenylurea]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 November, 1994 - 04 November, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

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:

423-070-8

EC Name:

-

Cas Number:

58890-25-8

Molecular formula:

not applicable (reaction mass)

IUPAC Name:

3-cyclohexyl-1-[4-({4-[(cyclohexylcarbamoyl)amino]phenyl}methyl)phenyl]urea; 3-cyclohexyl-1-[4-({4-[(phenylcarbamoyl)amino]phenyl}methyl)phenyl]urea; 3-phenyl-1-[4-({4-[(phenylcarbamoyl)amino]phenyl}methyl)phenyl]urea

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): KY-RB
- Description: White powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 8-9 weeks
- Weight at study initiation: 1495 - 1725 g
- Housing: Individually housed in labelled cages with perforated floors.
- Diet: Free access to standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands)
- Water: Free access to tap-water diluted with decalcified water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: The test substance was moistened with distilled water.

Controls:

other: The untreated contralateral flank of each animal served as controls

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 grams

VEHICLE
The test substance was moistened with vehicle.

Duration of treatment / exposure:

Single application

Observation period:

14 days

Number of animals:

3 males

Details on study design:

TEST SUBSTANCE PREPARATION
The test substance was ground to a powder using a mortar and pestle. Subsequently, the test substance was moistened with distilled water, immediately before application, to ensure close contact to the animal's skin.

TEST SITE
Approximately 24 hours before treatment, the dorsal fur was shaved with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm). Whenever considered necessary to facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.

The test substance was applied to the skin of one flank, using a Scotchpak non-woven patch of 2x3 cm.

REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using a tissue with tap water and subsequently a dry tissue.

OBSERVATIONS (kort allemaal!)
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to application)
- Necropsy: not performed
- 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:

mean

Remarks:

animal #1, #2 and #3

Time point:

other: 24, 48 and 72 hours.

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

other: 24, 48 and 72 hours.

Score:

0

Max. score:

4

Irritant / corrosive response data:

No signs of skin irritation were observed in the treated skin-areas of any of the three rabbits after 4 hours exposure to KY-RB, during the 72 hours observation period. There was no evidence of a corrosive effect on the skin.

Other effects:

No staining of the treated skin by the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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

Executive summary:

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

No signs of skin irritation were observed in the treated skin-areas of any of the three rabbits after 4 hours exposure to KY-RB, during the 72 hours observation period. There was no evidence of a corrosive effect on the skin.

Based on the results, KY-RB does not have to be classified for skin irritation according to Regulation (EC) No 1272/2008.