3-[(4-chloro-2-nitrophenyl)azo]-2-methylpyrazolo[5,1-b]quinazolin-9(1H)-one

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: Comparable to OECD Guideline 404 with acceptable restrictions (occlusive conditions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Fed. Reg. 38, No. 187, § 1500.41, p. 27019 of Sep. 27, 1973

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(occlusive conditions, 72 h reading missing)

Principles of method if other than guideline:

Method: Draize Test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-[(4-chloro-2-nitrophenyl)azo]-2-methylpyrazolo[5,1-b]quinazolin-9(1H)-one

EC Number:

277-823-9

EC Name:

3-[(4-chloro-2-nitrophenyl)azo]-2-methylpyrazolo[5,1-b]quinazolin-9(1H)-one

Cas Number:

74336-59-7

Molecular formula:

C17H11ClN6O3

IUPAC Name:

3-[(4-chloro-2-nitrophenyl)diazenyl]-2-methylpyrazolo[5,1-b]quinazolin-9(1H)-one

Details on test material:

- Name of test material (as cited in study report): Pigmentorange Kan 78/1775
- Test substance number: 80/404
- Physical state: solid, orange
- Analytical purity: > 98 %
- Lot/batch No.: Batch 8

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Mean weight at study initiation: males 2.74 kg (2.96, 2.69, 2.56 kg), females 2.82 kg (3.15, 2.69, 2.61 kg)
- Housing: 1 animal per cage; Cage made of stainless steel with wire mesh walk floor; floor area: 40 cm x 51 cm
- Diet: Ovator Solikanin 4 mm; Muskator-Werke, Düsseldorf 1, Germany (about 130 g per animal daily)
- Water: About 250 mL water per animal daily: fully demineralized water (Mondays - Fridays), tap water (Saturday/Sunday)
- Acclimation period: about 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 50 - 80
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Clipping of fur at least 15 hours before the beginning of the study

Vehicle:

water

Controls:

other: Untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Coating of the test patch with a layer of about 0.5 mm of a 50% formulation (with 2.5 x 2.5 cm about 0.5 g) is applied; due to the natural moistness of the skin, distilled water is used for the preparation of the formulation in order to have nearest to physiological study conditions.
- Concentration (if solution): 50% aqueous formulation

Duration of treatment / exposure:

24 hour(s)

Observation period:

8 days

Number of animals:

6 (3 males and 3 females)

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm intact and abraded skin each, upper third of the back or flank

REMOVAL OF TEST SUBSTANCE
- Washing: Remaining test substance is wiped off and washing is done with water

SCORING SYSTEM: According to J. H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health

READINGS: 24, 48 , and 72 h and 8 d after the beginning of application

ADDITIONAL EXAMINATIONS: After sacrifice the animals are examined by gross pathology. If there are clinical signs of necroses, these are confirmed by gross-pathological examination after incision of the skin.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Reversibility:

other: not applicable

Remarks on result:

other: erythema score could not be read because of staining due to the color of the test substance

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

No effects were observed 8 days after treatment.

Other effects:

No other effects observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

CLP: not classified
DSD: not classified