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Diss Factsheets
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EC number: 619-636-0 | CAS number: 125971-57-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-01-04 to 1990-03-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study was conducted according to GLP guidelines as described by the FDA (21 CFR P
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): 132,408
- Substance type: powder
- Physical state: solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc, Boyertown, PA
- Age at study initiation: young
- Weight at study initiation: not specified
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
All housing and care conformed to the standard established in the "Guide for the care and use of laboratory animal" DEHW Publication No. (NIH) 85-23
Test system
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g into one eye of each rabbit
- Duration of treatment / exposure:
- 72 hours for 6 animals
The eye of three animals was irrigated thoroughly with destilled water thirty seconds after the test article instillation until all visible test article was removed. - Observation period (in vivo):
- 72 hours
time points were 1, 24, 48 and 72 hours - Number of animals or in vitro replicates:
- 6+3
treatment of only one eye - Details on study design:
- SCORING SYSTEM: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 1 hour
- Score:
- 12.3
- Max. score:
- 19
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: non-irrigated
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 1 hour
- Score:
- 4
- Max. score:
- 6
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: irrigated 30 seconds after instillation
- Irritant / corrosive response data:
- Non irrigated group:
The test article instillation caused iritis and conjunctival irritation with blistering. No ocular irritation was present in one animal at the 24 hour reading and the remaining five animals at the 48 hour reading. The untreated eye of each animal appeared normal throughout the observation period. The maximum eye irritation score was 12.3 which was calculated from individual scores recorded one hour after the test article instillation.
Irrigated group:
The test article instillation caused iritis and conjunctival irritation with blistering. No ocular irritation was present in one animal at the 24 hour reading and the remaining two animals at the 48 hour reading. The untreated eye of each animal appeared normal throughout the observation period. The maximum eye irritation score was 4.0 which was calculated from individual scores recorded one hour after the test article instillation. - Other effects:
- -
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Under the conditions of this study, PD 132,408 is considered minimally irritating to rabbit eyes without irrigation and with irrigation 30 seconds after administration. Irrigation after 30 seconds reduced the severity of ocular irritation.
- Executive summary:
The primary irritation potential of PD 132408 after the instillation into the eyes of male New Zealand white rabbits was examined in this study. Under the conditions of this study, PD 132,408 is considered minimally irritating to rabbit eyes without irrigation and with irrigation 30 seconds after administration. Irrigation after 30 seconds reduced the severity of ocular irritation.
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