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Registration Dossier
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EC number: 446-630-3 | CAS number: 181587-01-9
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 Mar - 24 Mar 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Current version adopted in 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Guideline in place during study conduct: adopted in 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA), Department of Science and Technology, Government of India
Test material
- Reference substance name:
- -
- EC Number:
- 446-630-3
- EC Name:
- -
- Cas Number:
- 181587-01-9
- Molecular formula:
- C13H9Cl2F3N4OS
- IUPAC Name:
- 5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-(ethanesulfinyl)-1H-pyrazole-3-carbonitrile
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sri Raghavendra Enterprises, Bangalore, India
- Age at study initiation: 8 months
- Body weight at study initiation: 2.41 - 2.74 kg (females)
- Housing: individually, in stainless steel cages (sized: 60 cm (L) x 45 cm (W) x 45 cm (H)) provided with stainless steel mesh bottom
- Diet: extruded pelleted rabbit feed 'Amrut' (Pranav Agro Industries Ltd., Sangli, India), ad libitum
- Water: filtered and UV irradiated water in drinking water quality, ad libitum
- Acclimation period: 7 - 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): 48 - 64
- Air changes (per hr): 12.36
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 Mar 2016 To: 24 Mar 2016
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test substance was moistened with water.
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g, moistened with water at the time of application - Duration of treatment / exposure:
- Initial test: 3 min, 1 h and 4 h
Confirmatory test: 4 h - Observation period:
- Initial test: 3 days; reading time points: immediately after the patch was removed after 3 min, 1 and 4 h exposure and 1, 24, 48 and 72 h post exposure (after removing the patches)
Confirmatory test: 3 days; reading time points: 1, 24, 48, and 72 h post 4-h exposure (after removing the patches) - Number of animals:
- 3 animals in total (initial test: 1 animal, confirmatory test: 2 animals)
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the dorsal skin of the animal
- Type of wrap: The applied test substance was covered with a gauze patch, the latter being fixed with a gauze bandage wrapped around the animal and secured with tape.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was wiped off and the treatment area was gently washed with analytical grade water.
- Time after start of exposure: 4 h
SCORING SYSTEM:
Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test substance did not cause any skin reaction in the form of erythema or oedema in neither of the animals tested.
- Other effects:
- No clinical signs of systemic toxicity were observed. Body weights were not affected during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
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