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EC number: 277-823-9 | CAS number: 74336-59-7
Toxicological information
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:
- 1 981
- 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
- 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
Constituent 1
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
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