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Diss Factsheets
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EC number: 632-619-2 | CAS number: 881685-58-1
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Jan 2014 to 26 Jan 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 632-619-2
- EC Number:
- 632-619-2
- Cas Number:
- 881685-58-1
- Molecular formula:
- C20 H23 F2 N3 O
- IUPAC Name:
- 632-619-2
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: Male
- Age at study initiation: ~11 weeks
- Weight at study initiation: 2668 g – 2988 g
- Housing: Animals were housed individually in AAALAC approved metal wire rabbit cages. Cages are of an open wire structure and cages are placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet: UNI diet for rabbits. Ad libitum
- Water: Tap water. Ad libitum
- Acclimatisation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17.7 – 21.7 °C
- Humidity: 23 – 58 %
- Air changes: 15-20 air exchanges/hour
- Photoperiod: 12/12 hours light/dark
IN-LIFE DATES: From: 21 Jan 2014 To: 26 Jan 2014
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g of the test material - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- PRE-STUDY EXAMINATION
- The test was performed on 3 male rabbits, checked for normal skin conditions.
TEST SITE
- Area of exposure: An area of 10 x 10 cm on the back and flanks of the rabbits was clipped with an electric clipper 24 hours before the treatment.
- Type of wrap if used: A surgical gauze pad (ca. 2.5 x 2.5 cm) was applied to the intact skin of the clipped area and was kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The entire trunk of the animals was than wrapped with plastic wrap held in place with an elastic stocking.
REMOVAL OF TEST SUBSTANCE
- Washing: The dressing was then removed and the skin was flushed with lukewarm tap water to clean the application site.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS : 1, 24, 48 72 hours after the end of exposure
SCORING SYSTEM:
- Method of calculation: The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004 which was based on the Draize scoring system. For criteria, see 'Any other information on materials and methods incl. tables'.
OTHER OBSERVATIONS
- Clinical signs, including viability/mortality, were recorded daily from the day of application of the animals to the termination of the test.
- Body weights were recorded on the day of application and the end of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Irritant / corrosive response data:
- The primary irritation index was 0.00 (out of a maximum score of 8.0). No corrosive effects were noted on the treated skin of any animal at any of the observation intervals. No local dermal signs were observed in the treated animals throughout the study.
- Other effects:
- CLINICAL OBSERVATIONS
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hour observation.
BODY WEIGHT
The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The application of the test material did not result in any signs of skin irritation.
- Executive summary:
Three young adult male New Zealand White rabbits were treated by topical, semi-occlusive application of 0.5 g test material to their intact shaved flanks in a study according to OECD TG 404 and GLP principles. The test material was moistened with water to ensure good skin contact. The duration of treatment was 4 hours. The scoring of skin reactions was performed at 1, 24, 48 and 72 hours after removal of the dressing. The primary irritation index (P.I.I.) was calculated.
The mean average erythema and oedema scores of all animals over 24, 48 and 72 hours were 0. The P.I.I was 0. No local dermal signs were observed in the treated animals throughout the study. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hour observation. The body weights of all rabbits were considered to be within the normal range of variability.
The application of the test material did not result in any signs of skin irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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