Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione

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:

comparable to guideline study with acceptable restrictions

Remarks:

according to current guidelines (OECD 404) solid materials should be moistened.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Determination of irritation index according to Federal Register 38, No. 187, 27. 9. 1973, p 27019, § 1500.41

Deviations:

no

GLP compliance:

no

Remarks:

pre-guideline study

Test material

Test material information

Constituent 1

Reference substance name:

Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione

EC Number:

224-152-4

EC Name:

Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione

Cas Number:

4216-02-8

Molecular formula:

C26H12N4O2

IUPAC Name:

bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione

Test material form:

solid: nanoform

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- SPF-Albino-Himalayan
- Source: Hoechst AG, breeding colony
- Weight at study initiation: 1,5 - 2,0 kg
- Housing: single caged
- Diet: standard diet ERKA 8300 ad libitum
- Water: tap water ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved intact or shaved abraded with a scarifying instrument

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

24 h

Observation period:

examinations: 24, 48 and 72 h after application, i.e. 0, 24, 48 h after the end of treatment/exposure

Number of animals:

6

Details on study design:

0.5 g of the undiluted test substance is spread on a gauze patch, measuring 2,5 x 2,5 cm which is applied on the abraded and intact skin of 6 albino rabbits, clipped free of hair under occlusive conditions. After 24 hours of exposure, the patches are removed. Reactions are recorded 0, 24 and 48 h after the end of exposure.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal: # 1-6 each

Time point:

other: mean of 0, 24, 48 h after the end of exposure

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (edema) at any time

Remarks on result:

other: intact and abraded skin

Results 2

Irritation parameter:

erythema score

Basis:

animal: # 1-6 each

Time point:

other: mean of 0, 24, 48 h after the end of exposure

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (erythema) at any time

Remarks on result:

other: intact and abraded skin

Irritant / corrosive response data:

No skin reactions were observed in any animal at any timepoint.

Other effects:

no other effects reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions.

Conclusions:

According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions.

Executive summary:

Test material was subject to an acute dermal irritation/corrosion test in 6 Himalaya rabbits according to FDA guideline. Both intact and scarified skin sites of six rabbits were exposed to 500 mg test substance for 24 h under occlusive conditions and the skin responses were examined 0, 24, and 48 h after the end of exposure. No skin reactions were observed. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.