Registration Dossier
Registration Dossier
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EC number: 616-053-3 | CAS number: 74149-73-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions according to OECD gudeline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-methoxy-N-[4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)-2-nitrophenyl]benzamide
- EC Number:
- 616-053-3
- Cas Number:
- 74149-73-8
- Molecular formula:
- C19 H18 N4 O5
- IUPAC Name:
- 4-methoxy-N-[4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)-2-nitrophenyl]benzamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Nitropyridazinon synonymous to "Stufe, UDCG 115"
- Physical state: solid
- Analytical purity: 99.0 %
- Purity test date: 02 August 2001
- Lot/batch No.: RH 1/1 - 1/23
- Expiration date of the lot/batch: August 2002
- Storage condition of test material: at room temperature, in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: Housed in ABS-plastic rabbit cages , floor 4200 cm²
- Diet (e.g. ad libitum): Free access to Altromin 2123 maintenance diet rabbit, rich in crude fiber, totally-pathogen-free-TPF
- Water (e.g. ad libitum): Free access to tap water ( drinking water, municipal residue control, microbiol. controlled periodically )
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 21
- Humidity (%): 45 - 65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 : 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: cotton seed oil
- Controls:
- other: Untreated other side of animals served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- Area of exposure: approx. 6 cm2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: all animals
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: all animals
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Considering the reported data of this irritation study it can be stated that the test item Nitropyridazinon synonymous to "Stufe, UDCG 115" showed
no irritant/corrosive effects. - Executive summary:
In this irritation study the test item Nitropyridazinon synonymous to "Stufe, UDCG 115" was applied to one site of the closely clipped backs of 3 rabbits (strain NZW ) at a dose of 0.5 g per application site. The untreated other site served as control.
The application site was covered with a semi-occlusive bandage for a 4 hour-contact time.
Observations were recorded and compared to the control sites, 1 h, 24 h, 48 h and 72 hours after removal of the dressing.
The test item Nitropyridazinon synonymous to "Stufe, UDCG 115" showed no irritant affects on the intact skin after a contact time of 4 hours.
No other clinical signs of toxicity were found.
Considering the reported data of this irritation study it can be stated that the test item Nitropyridazinon synonymous to "Stufe, UDCG 115" showed no irritant/corrosive effects.
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