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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Fed. Reg. 38, No. 187, § 1500.41, p. 27019 of Sep. 27, 1973
Deviations:
no
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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