Registration Dossier
Registration Dossier
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EC number: 609-256-3 | CAS number: 365400-11-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 Apr - 17 May 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24 Apr 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 28 Jul 2015
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-[2-methanesulfonyl-4-(trifluoromethyl)benzoyl]-1,3-dimethyl-1H-pyrazol-5-ol
- EC Number:
- 609-256-3
- Cas Number:
- 365400-11-9
- Molecular formula:
- C14H13F3N2O4S
- IUPAC Name:
- 4-[2-methanesulfonyl-4-(trifluoromethyl)benzoyl]-1,3-dimethyl-1H-pyrazol-5-ol
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was pulverized.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL(NZW)BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Age at study initiation: approximately 6 months
- Weight at study initiation: 3020 - 3175 g
- Housing: individually in metal cages with excrement tray
- Diet: "Ssniff K-2" 4mm (manufacturer: Ssniff Spezialdiaeten GmbH, Soest, Germany), approximately 100 g/animal/day; once per day in the moming
- Water: tap water, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 20
- Photoperiod (hrs dark / hrs light): approximately 12/12
IN-LIFE DATES: From: 14 Apr 2004 To: 17 Apr 2004
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Remarks:
- (approximately 24 h before application)
- Vehicle:
- water
- Controls:
- other: the untreated contralateral skin area served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 - 502 mg
- Duration of treatment / exposure:
- 1st animal: 3 min, 1 h, 4 h
2nd and 3rd animal: 4 h - Observation period:
- 72 h
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: The test material was applied to the dorsolateral area of the trunk (treated skin was approximately 2.5 x 2.5 cm in size).
- Type of wrap if used: The test material was moistened with sterile water and was covered with a gauze patch which was held in place with "Surgifix No. 5" (Schumacher, Medical Produkte, Krefeld, Germany)
REMOVAL OF TEST SUBSTANCE
- Washing: The exposed skin was carefully washed with water.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1st animal: immediately after patch removal (3 min and 1 h treatment); 1, 24, 48 and 72 h after patch removal (4 h treatment)
2nd and 3rd animal: 1, 24, 48 and 72 h after patch removal
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals (4 h treatment)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals (4 h treatment)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation or corrosion were noted after treatment for 3 min or 1 h. No signs of irritation or corrosion were noted immediately after treatment for 4 h.
- Other effects:
- - Other adverse systemic effects: There were no relevant systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- The study was performed in accordance to OECD TG 404 under GLP conditions and is considered reliable. The test substance was non-irritant.
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