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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: 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:

-Purity: 99.6%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age: 3-5 months
- Weight : 1.8-2.2 kg
- Housing: Air-conditioned areas in single cages (battery system)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - rabbits, ad libitum as well as hay (approx. 15 g daily)
- Water (e.g. ad libitum): ad libitum

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: 0.3 mL of 0.9% NaCl

Controls:

no

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 500 mg test substance in solution prepared with 0.3 mL 0.9% NaCl

Duration of treatment / exposure:

4 hours

Observation period:

The evaluations took place 30 - 60 minutes as well as 24, 48 and 72 hours after removing the patch.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: semi-occlusive bond

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Removed carefully with lukewarm tap water
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

and scab formation

Basis:

mean

Time point:

24/48/72 h

Score:

0.6

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

48 hours after removal of the patch, the animals had a very light, hardly perceptible erythema. The skin surface of the animals was beige discolored partial. 72 hours post application all animals were free from neurological irritation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The examination of skin irritation at the rabbit resulted in that the test substance is not related to the present investigation according to the classification criteria of the guideline 83/467/EWG and the hazardous material regulation labeling required.

Executive summary:

Rabbits were exposed dermally to the test substance for 4 hours under semi-occlusive conditions in accordance with OECD Guideline 404. The evaluations took place 30 - 60 minutes as well as 24, 48 and 72 hours after removing the patch. 48 hours after removal of the patch, the animals had a very light, hardly perceptible erythema. The skin surface of the animals was beige discolored partial. 72 hours post application all animals were free from neurological irritation.