Urea,N'-[3-[[[(dimethylamino)carbonyl]amino]methyl]-3,5,5-trimethylcyclohexyl]-N,N-dimethyl-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-04-02 to 2001-04-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]

EC Number:

241-523-6

EC Name:

N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]

Cas Number:

17526-94-2

Molecular formula:

C13H20N4O2

IUPAC Name:

3-[3-(dimethylcarbamoylamino)-4-methylphenyl]-1,1-dimethylurea

impurity 1

Reference substance name:

3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea

Cas Number:

17607-23-7

Molecular formula:

C13H20N4O2

IUPAC Name:

3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea

impurity 2

Reference substance name:

unknown

IUPAC Name:

unknown

impurity 3

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): N,N" (4-Methyl-m-phenylen)bis(N',N'-dimethylharnstoff)
- Substance type: organic
- Physical state: odourless solid
- Analytical purity: 100%
- Lot/batch No.: 0232 07
- Expiration date of the lot/batch: March 2003
- Stability under test conditions: stable at dry storage conditions for at least 2 years
- Storage condition of test material: store sry in closed containers

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen.
- Age at study initiation:
- Weight at study initiation:
- Housing: semi-barrier in air conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/-3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): at least 10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated other side of the dorsal area served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

Animals were observed for 72 hours after dosing

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- % coverage: no data
- Type of wrap if used: gauze patch, held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using water
- Time after start of exposure: 4 h

SCORING SYSTEM: see table 1 in "Any other information on materials and methods"

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

0

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Other effects:

no other effects

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item TDI-Urone is not considered to be irritating.

Executive summary:

In a primary dermal irritation study according to OECD 404 three female New Zealand White Rabbits Crl:KBL (NZW) BR. were dermally exposed to 0.5 g of TDI-Urone for 4 hours to approximate 6 cm² of the skin on one side of the dorsal area. Animals then were observed for 3 days. The test item showed no irritant effects on the intact skin after a contact time of 4 hours. No skin reactions were recorded throughout the observation period of 72 hours as compared to untreated control sites. There were no significant body weight changes during the contact and observation period. Therefore, TDI-Urone is not irritating to the skin.