4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

402-130-7

EC Name:

-

Cas Number:

106246-33-7

Molecular formula:

C21 H28 Cl2 N2

IUPAC Name:

4-[(4-amino-2-chloro-3,5-diethylphenyl)methyl]-3-chloro-2,6-diethylaniline

Details on test material:

- Substance code: P5367
- Batch No.: 12 April 1985
- Appearance: Off-white to greyish powder
- Storage: At ambient temperature in the dark

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: stable

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: female
- Source: Ranch Rabbits, Crowley
- Age: at least 12 weeks
- Weight at study initiation: 2.10 - 4.05 kg
- Housing: individually in grid floor cages
- Diet: Standard Rabbit Diet, Special Diets Services Ltd., Stepfield
- Water: Mains water was provided at all times and dispensed from glass water bottles
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature: 16 - 22°C
- Humidity: 40 - 70%
- Air changes: 10 changes /hour; single air-conditioned room
- Photoperiod: 14 hours darkness; 10 hours fluorescent lightning

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 hours

Observation period:

observations were done 1, 24, 48 and 72 hours after treatment

Number of animals:

3

Details on study design:

TREATMENT:
The back of each animal was clipped free of hair the day prior to treatment using electric veterinary clippers. A portion of test article (500 mg, moistened with water) was applied to an area of skin approximately 6 cm2 on each animal and covered with a gauze patch. The patch was occluded and secured using a strip of impermeable adhesive tape. A plastic collar was placed around the neck of each animal to prevent premature removal of the wrappings and ingestion of the test article. Four hours after application the patches were removed and the skin wiped with a disposable paper towel moistened with water to remove any test article still remaining.

EVALUATION OF EFFECTS:
One hour after removal of the wrappings the skin reactions were scored using the scale below.* The evaluation was repeated 24, 48 and 72 hours after removal of the patches. No irritation was noted at the 72 hour observation and the study was terminated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No adverse skin reactions were noted up to 72 hours post-administration, when the study was terminated.

Other effects:

No adverse skin reactions were noted up to 72 hours post-administration, when the study was terminated.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was found to be non-irritating to rabbit skin.

Executive summary:

The study was performed 1988 as GLP-test following OECD-method 404. The used species were New Zealand White rabbits; 3 females were treated with 500 mg test item, moistened with water. No effects were observed throughout the study period, all irritation scores were 0. In conclusion, the test item is not irritant to rabbit skin.