2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 28 JUL 1992 to 31 JUL 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA-TSCA 40 CFR 798

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione

EC Number:

221-424-4

EC Name:

2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione

Cas Number:

3089-17-6

Molecular formula:

C20H10Cl2N2O2

IUPAC Name:

2,9-dichloro-5,7,12,14-tetrahydro-5,12-diazapentacene-7,14-dione

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- 4 male /2 female animals tested
- Source: Ace animals
- Weight at study initiation: 2 to 2.6 kg
- Housing: 1/ cage in suspended
- Diet: Fresh purina rabbit chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light):12 /12

4 male /2 female animals tested

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g was pasted with distilled water

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

6 (4 male/ 2 female)

Details on study design:

TEST SITE
- Area of exposure: 6 cm² covered with gauze patch
- Type of wrap if used: semiocclusive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently washung with distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

- there were no edema or erythema detectable (score 0) at any time point in any animal

Other effects:

During the whole testing period the skin at the dose site remained purple coloured. One animal showed systemic effects (diarrhea and soiled anogenital region) at the 24 and 48 hour reading which disapeared until the 72 hour reading.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

According to the classification criteria of Regulation (EC) No 1272/2008 the test material 2, 9-Dichloroquinacridone is not irritating to skin under these test conditions. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.

Executive summary:

Test material 2, 9-Dichloroquinacridone was subject to an acute dermal irritation/corrosion test in 6 New Zealand white rabbits similar to OECD TG 404. Beside the purple staining of the dose site, no relevant skin reactions occurred during the 4 h exposure to 500 mg of test item (pasted with distilled water) as well as during the following 72 h observation period. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.