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Diss Factsheets
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EC number: 687-691-8 | CAS number: 709031-43-6
- 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:
- November 2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Batch # ZD48725 Lot 002 (Dispensary number 0683/02-1340)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species, Strain and Supplier: New Zealand White Rabbits of the Cr;L NZW/Kbl.BR strain were obtained from the Charles River UK Ltd, Margate on 2 and 9 July 2002. The animals were examined annd weighed on the day day of arrival. The rabbitw were in a body weight range of 2.19 to 2.80 kg on the day before dosing. Based on information from the supplier the rabbits were at least 10 to 12 weeks old on Day 1.
Caging: On arrival rabbits were housed individually in cages. The cages were perforated polypropylene trays on a stell rack with mesh walls - no bedding was provided. The minimum cage dimensions are 45 x 62 x 62 cm. Where practicable hay and plastic in-cage shelters were provided for environmental enrichment.
Diet and Water: UAR Rabbit D10 (pelleted) from Charles River UK, Margate was freely available to the animals at all times. Each batch of diet had been analysed for specific constituents and contaminants by the manufacturer. Mains water was provided, ad libitum, via water bottles attached to the cage walls. The wter had been periodically analysed for specific contaminants. No contaminants were present in diet, or water at levels which might have interfered with achieving the objective of the study.
Environment: The holding room was designed to permit at least 15 air changes per hour and to maintain temperatures of 16 to 22oC. humidity was not actively controlled but was expected to remain within the range 40 to 80% RH. Recordings of maximum temperature and humidity were made twice daily during the week and once a day on Saturdays, Sundays and public holidays. The room was illuminated by fluorescent strip-lights for twelve hours daily.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 500mg on dermal test site of 30 x 20 cm
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 0
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hr
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hr
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hr
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 0
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hr
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hr
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hr
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A single semi-occluded application of BMS 528235-01 to intact rabbit skin for four hours was found to be non-irritating
- Executive summary:
The study was conducted to determine the irritation or corrosion caused to intact rabbit skin following a single (4 hour), semi-occluded, topical application of BMS 528235 -01. The test article (500 mg) was applied to a 30 x 20 mm area on the clipped and moistened dorsum of each of three New Zealand White RAbbits on Day 1. The treated area of skin was covered by a semi-occlusive bandage for four hours. Dermal reactions to treatment were assessed for three days after removal of the dressings. No reactions were observed following a single semi-occluded, topical application of BMS 528235 -01 to intact rabbit skin for four hours. In conclusion a single semi-occluded application of BMS 528235-01 to intact rabbit skin for four hours was found to be non-irritating
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