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EC number: 810-161-6 | CAS number: 1229654-66-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Apr - 06 Apr 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- adopted in 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GYEMSZI, National Institute for Quality- and Organizational Development in H ealthcare and Medicine, Budapest, Hungary
Test material
- Reference substance name:
- 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-1,2,3,4-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide
- EC Number:
- 810-161-6
- Cas Number:
- 1229654-66-3
- Molecular formula:
- C22 H16 Cl F3 N10 O2
- IUPAC Name:
- 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-1,2,3,4-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S&K-Lap Co.Ltd., Kartal, Hungary
- Age at study initiation: 13 - 14 weeks
- Housing: individually in AAALAC approved metal wire rabbit cages
- Diet: UNI diet for rabbits (Agribands Europe Hungary PLC, Karcag, Hungary), ad libitum
- Water: tap water from the municipal supply, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.8 - 20.9
- Humidity (%): 24 - 56
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- approximately 24 h before application
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Duration of treatment / exposure:
- Initially, a single animal was treated for 1 h. As no significant irritant effect was observed after the 1 h exposure, the test was completed using the 2 remaining animals with an exposure period of 4 hours.
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 10 x 10 cm²
- Type of wrap: the test material was held in contact with the skin by gauze pads dampened with water to ensure good contact with the skin. An adhesive hypoallergenic plaster kept the gauze pads in contact with the skin. The entire trunk of the animals was then wrapped with plastic wrap with an elastic stocking.
REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed with lukewarm water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48, 72 h
SCORING SYSTEM:
- Method of calculation: numerical scoring system listed in the Commission Directive 2004/73/EC 2004 which is based on the 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:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Very slight erythema (score 1) was noted in all animals at 1 h after patch removal and very slight erythema (score 1) was noted in two rabbits 24 hours after patch removal.
- Other effects:
- - Other adverse local effects: At the observation time points, 48 and 72 h after patch removal, there were no local signs on the skin of the treated animals.
- Other adverse systemic effects: No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability.
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:
- CLP: not classified
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