Registration Dossier
Registration Dossier
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EC number: 918-045-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-8-6 to 1997-8-9
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-{2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1H,4H,7H-pyrazolo[4,3-d]pyrimidin-7-one
- EC Number:
- 918-045-8
- Cas Number:
- 139755-83-2
- Molecular formula:
- C22H30N6O4S
- IUPAC Name:
- 5-{2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1H,4H,7H-pyrazolo[4,3-d]pyrimidin-7-one
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 92480/J/17/1
- Expiration date of the lot/batch: Not Advised
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2.3-2.9 kg
- Housing: Individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): SDS Stanrab (P) SQC Rabbit Diet ad libitum
- Water (e.g. ad libitum): ad libiutm
- Acclimation period: Of unknown period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5-25
- Humidity (%): 51-73
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml Distilled water
- Purity: ~100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 mm x 25 mm
- Type of wrap if used: "Elastoplast" elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm water and dried
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
60 minutes, 24 hours, 48 hours, and 72 hours after exposure
SCORING SYSTEM:
Local &mat irritation was assessed using; the prescribed numerical system:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth)
preventing erythema reading 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately I millimetre) 3
Severe oedema (raised more than 1 millimetre and extending
beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 60 min
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 60 min
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 60 min
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 60 min
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 60 min
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 60 min
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritant / corrosive response data:
- No dermal reaction to treatment was observed in any animal throughout the study.
Any other information on results incl. tables
| Rabbit no. and Sex | E = Erythema O = Odema |
Day 1 | Day 2 | Day 3 | Day 4 |
| 2159 Female | E | 0 | 0 | 0 | 0 |
| 2159 Female | O | 0 | 0 | 0 | 0 |
2160 Female |
E |
0 |
0 |
0 |
0 |
2160 Female |
O |
0 |
0 |
0 |
0 |
2161 Female |
E |
0 |
0 |
0 |
0 |
2161 Female |
O |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- UK-92,480 did not elicited any dermal irritation and is not classified per GHS criteria.
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