4-chloroaniline

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Verordnung über gefährliche Stoffe (Gefahrstoffverordnung - GefStoffV) vom 26. August 1986 (BGB1. IS. 1470)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-chloroaniline

EC Number:

203-401-0

EC Name:

4-chloroaniline

Cas Number:

106-47-8

Molecular formula:

C6H6ClN

IUPAC Name:

4-chloroaniline

Details on test material:

- Name of test material (as cited in study report): p-chloranilin, DS
- Physical state: solid (crystalline light-brown product)
- Analytical purity: 99.5%
- Purity test date: 12.09.1990
- Product number/code: Hoe CG 0080 OD ZD00 0002
- Storage condition of test material: at 20°C in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hochst AG, Kastengrund, Germany, conventional breeding
- Age at study initiation: about 3-5 months
- Weight at study initiation: 3.2-3.7 kg
- Housing: animals were housed in individual cages in full air-conditioned rooms
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät-Kaninchen, Altromin GmbH, Lage/Lippe, Germany, ad libitum plus hey (about 15 g daily)
- Water (e.g. ad libitum): deionized, chlorinated water from automatic drinking trough ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12 hours per day

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg per plaster

Duration of treatment / exposure:

4 hours

Observation period:

30-60 minutes, and 24, 48, and 72 hours

Number of animals:

3

Details on study design:

Approximately 24 hours prior to the start of the experiment 3 rabbits were depilated in the dorsal area of the body with an electric hair clipper on an area of about 25 cm². Only animals with intact skin were used.
500 mg p-Chloroanilin, DS (moistened with 0.3 mL 0.9% NaCl) was applied on each animal. The moistened test substance was applied on adhesive plaster with 2.5 x 2.5 cm cellulose layer on the prepared skin site. Subsequently, the area was covered with a semiocclusive bandage.
The exposure time was 4 hours. After the exposure period, the remaining test substance was carefully removed from the skin with tepid tap water.
The assessments were made for 30-60 minutes and then at 24, 48, and 72 hours after the removal of the patch.
The erythema and eschar formation and edema were evaluated numerically according to DRAIZE score method.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

Throughout the trial period absolutely no irritation was observed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

Kreiling (Hoechst AG, 1990):

A skin irritation test has been conducted on 3 albino rabbits according to OECD guideline 404. 500 mg p-Chloroanilin, DS (moistened with 0.3 mL 0.9% NaCl) was applied on each animal. Subsequently, the area was covered with a semiocclusive bandage The Draize score for erythema and edema resulted to be "0".

On the basis of the results of the present study can be concluded that 4-chloroaniline is not skin irritant.