A mixture (1:2:1) of: bis(N-cyclohexyl-N'-phenyleneureido)methylene; bis(N-octadecyl-N'-phenyleneureido)methylene; bis(N-dicyclohexyl-N'-phenyleneureido)methylene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 August 1989 - 30 September 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD guidelines but without GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

A mixture (1:2:1) of: bis(N-cyclohexyl-N'-phenyleneureido)methylene; bis(N-octadecyl-N'-phenyleneureido)methylene; bis(N-dicyclohexyl-N'-phenyleneureido)methylene

EC Number:

406-550-1

EC Name:

A mixture (1:2:1) of: bis(N-cyclohexyl-N'-phenyleneureido)methylene; bis(N-octadecyl-N'-phenyleneureido)methylene; bis(N-dicyclohexyl-N'-phenyleneureido)methylene

IUPAC Name:

Reaction mass (1:2:1) of bis(N-cyclohexyl-N'-phenyleneureido)methylene and bis(N-octadecyl-N'-phenyleneureido)methylene and bis(N-dicyclohexyl-N'-phenyleneureido)methylene

Test material form:

solid: particulate/powder

Details on test material:

Description: White yellowish solid
Test substance storage: At room temperature in the dark

Test animals

Species:

rabbit

Strain:

other: Japanese white albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Inoue Laboratory Animal Center
- Age at study initiation: 11-12 weeks old
- Weight at study initiation: 2.32 - 2.59 kg.
- Housing: Animals were housed individually in aluminium cages.
- Diet: Free access to diet for rabbits (RC4, Oriental Yeast Co., Ltd.). Animals were deprived of food during the 4 hours treatment.
- Water: Free access to tap water.
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
set to maintain:
- Temperature (°C): 18 – 26
- Humidity (%): 40 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29 August 1989 to 02 September 1989

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: The test substance was dampened with 0.5 mL liquid paraffin.

Controls:

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

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours, single application.

Observation period:

72 hours.

Number of animals:

6

Details on study design:

TEST SUBSTANCE PREPARATION
The test substance was dampened with 0.5 mL liquid paraffin.

TEST SITE
Approximately 24 hours before treatment, electric clippers for animal use were used to shear their fur, and using an electric razor to shave the 6 rabbits' backs, the left and right sites were prepared. The test substance was applied to the skin of one flank, using a 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 absorbent cotton and acetone.

OBSERVATIONS
- Mortality/Viability: One daily.
- Toxicity: Once daily.
- Body Weight: Once daily
- 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, #3, #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1, #2, #3, #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No skin reaction such as erythema (red spots) or edema (swelling) was observed throughout the observation period.

Other effects:

None of the tested animals were found affected by the test substance and there were no significant changes in general condition and body weight.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating.

Remarks:

According to Regulation (EC) No. 1272/2008.

Conclusions:

In an skin irritation study with rabbits, performed according to OECD 404 test guidelines, no irritation was observed.

Executive summary:

A skin irritation study with six rabbits was performed (4 hours application) with the substance according to OECD 404 test guideline.

No skin reaction such as erythema (red spots) or edema (swelling) was observed throughout the observation period of 72 hours.

None of the tested animals were found affected by the test substance and there were no significant changes in general condition and body weight.

Based on the results of the study it is concluded that MDI/CHA/ODA/DCHA does not need to be classified according to Regulation (EC) No. 1272/2008.