Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 October 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in acccordance with recognised guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
- Principles of method if other than guideline:
- Screening for the eye irritancy potential of PF-00346643 using the Bovine Corneal Opacity and Permeability test (BCOP test). This report describes the ocular irritation properties of PF-00346643 on an isolated bovine cornea. The possible ocular irritancy of PF-00346643 was tested through topical application for 10 minutes.
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): PF-00346643
- Substance type: pure substance
- Physical state: pale yellow oil
- Analytical purity: 88.9%
- Lot/batch No.: 115565-67-1
- Expiration date of the lot/batch: 31 May 2008
- Stability under test conditions: stable
- Storage condition of test material: in a refrigerator (2-8°C) in the dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 10 minutes
- Observation period (in vivo):
- Observation/measurements in the study were recorded electronically using Multiskan spectrum version 1.00 for optical density measurement.
Results and discussion
Any other information on results incl. tables
Table 1 Summary of opacity, permeability and in vitro scores
Treatment |
Mean Opacity1 |
Mean Permeability1 |
Mean in vitro irritation Score 1,2 |
Negative control |
0(0) |
0.000 (0.004) |
0.0 (0.1) |
Positive control |
87 |
4.400 |
153.3 |
PF-00346643 |
2 |
-0.001 |
2.0 |
1
Negative control corrected values (between brackets uncorrected values) Calculated using the negative control mean opacity and mean permeability values.
2
The
uncorrected individual in
vitro irritancy
scores for the negative controls ranged from 0.0 to 0.1. The individual
positive control in
vitro irritancy
scores ranged from 136.1 to 172.4
The corneas treated with PF-00346643 showed an opacity value of 2 and a permeability value ranging from -0.002 to -0.001. Hence, the in vitro irritancy score of all corneas was 2.0 after 10 minutes of treatment with PF-00346643.
See background material section for detailed results tables.
Applicant's summary and conclusion
- Conclusions:
- The test is valid and PF-00346643 is non irritant in the Bovine corneal Opacity and Permeability test under the experimental conditions described.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.