o-phenylenediamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

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)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

o-phenylenediamine

EC Number:

202-430-6

EC Name:

o-phenylenediamine

Cas Number:

95-54-5

Molecular formula:

C6H8N2

IUPAC Name:

benzene-1,2-diamine

Details on test material:

- Name of test material (as cited in study report): o-Phenylendiamin

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals are taken from HOECHST AG, Kastengrund, conventional Breeding, origin: Madörin, Füllingsdorf, Switzerland

weight: 1.8 - 2.2 kg
age: 3- 5 month

The animals stayed in single cages (batterie storage)

Room temperature: 20 +/- 3 °C
rel. air humidity: 50 +/- 20 %
Ilumination: 12 hours daily
Food: Altromin 2123 diat rabbits ad libitum, company Altromin-GmbH, Lage/Lippe, Germany, hay approx. 15 g / day
Water: de-ionised, chlorinated water, ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

not required

Amount / concentration applied:

500 mg o-Phenylenediamine mixed with 0.3 ml 0.9 % NaCl was applied to a patch of 2,5*2,5 cm, which was fixed at the shaved skin area with a adhesive tape and covered with a semiocculsive bandage.

Duration of treatment / exposure:

The duration of traeatment was 4 hours. After this time the patch was removed and the remaining test substance was washed with warm tap-water.

Observation period:

Examinations were done 30 - 60 minutes and 24, 48, 72 hours after removal of the patch.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: animal # 1, 2 each

Time point:

other: mean of 24, 48, and 72h

Score:

0.7

Reversibility:

fully reversible within: 72h

Results 2

Irritation parameter:

erythema score

Basis:

other: animal # 3

Time point:

other: mean of 24, 48, adn 72h

Score:

0.3

Reversibility:

fully reversible within: 48h

Results 3

Irritation parameter:

edema score

Basis:

other: animal # 1, 2, 3 each

Time point:

other: mean of 24, 48, and 72h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: no signs of irritation at any time

Other effects:

skin discoloration (large scale beige) which was fully reversible within 72h

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.

Executive summary:

o-Phenylendiamine was tested for skin irritating or skin corrosive properties according to OECD 404. Following this protocol 500 mg of the test substance mixed with 0.3 ml physiol. saline were applied to the shaved skin of 3 New Zealand Whites Rabbits. After 24h exposure time the semiocclusive covering was removed. In the following 48h (=72h after beginning of treatment) the animals were periodically examined for signs of skin irritation or skin corrosion. Mean scores (mean of 24, 48, and 72h) were calculated for oedema and erythema for each rabbit.

Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.