p-phenylenediamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Reference 2

Reference Type:

other: raw data related to study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: company guideline previous to OECD guideline implementation that is similar to OECD 404

Deviations:

not applicable

Principles of method if other than guideline:

Using an electrical shaver the fur of the regio (abdominalis) lateralis of six rabbits (weight: 1.5 – 2kg) was shaved on two neighbouring areas (each 3x3cm). One of the depilated areas was scarificated. 500 mg of the test item mixed with 0.25 ml Propanediol were spread on lobes of 2.5x2.5cm of surgical gauze which were transferred onto the previously prepared skin areas. Using impermeable and indifferent PVC foil (6-8cm wide) the lobules were covered occlusively. Following this the torso of the experimental animals was wrapped with elastic bandages. Treatment time was 24hrs. Animals were examined immediately after exposure (i.e. 24hrs after start of treatment), 48hrs and 72hrs after start of treatment.

GLP compliance:

no

Remarks:

Performed prior to GLP implementation

Test material

Test material information

Constituent 1

Reference substance name:

p-phenylenediamine

EC Number:

203-404-7

EC Name:

p-phenylenediamine

Cas Number:

106-50-3

Molecular formula:

C6H8N2

IUPAC Name:

benzene-1,4-diamine

Details on test material:

- Name of test material (as cited in study report): Nako H (p-Phenylendiamin)

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

SPF-Albino-Himalayan rabbit, strain: HIMK (SPFWiga)
rabbits in single cages, feeded with ERKA 8300 of Robert Koch oHG/Hamm and regular water, both offered ad libitum
rabbits weight: 1,5 - 2,0 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved/intact or shaved/abraded

Vehicle:

other: Propanediol

Controls:

not required

Amount / concentration applied:

500 mg substance, mixed with 0.25 ml Propandiol

Duration of treatment / exposure:

duration of treatment: 24 h, without washing

Observation period:

examinations were done 24 h, 48 h and 72 h from the beginning of treatment

Number of animals:

6 rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: Animal # 14/15/16/17/18/19 (intact skin) each

Time point:

other: mean of 24, 48, 72h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: no signs of irritation during the entire observation period

Results 2

Irritation parameter:

edema score

Basis:

other: Animal # 14/15/16/17/18/19 (intact skin) each

Time point:

other: mean of 24, 48, 72h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: no signs of irritation during the entire observation period

Irritant / corrosive response data:

Scores of the abraded skin are not presented because these data are of no relevance for classification.

Other effects:

none during entire study period

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:

Nako H (p-Phenylendiamin) was tested for skin irritating or skin corrosive properties according to a company guideline similar to OECD 404. Following these protocol 500 mg of the test substance mixed with 0.25 ml Propanediol were applied to the shaved/intact or shaved/abraded skin of 6 Himalayan rabbits. After 24h exposure time the occlusive covering was removed. In the following 48 h (=72h after beginning of treatment) the animals were periodically examined for signs of skin irritation and or 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.