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EC number: 424-110-7 | CAS number: 194602-23-8 UK-143,108
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7th- 16th of August 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study completed according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Three rabbits were each administered a single ocular dose of 50 mg of the test substance and observed for seven days after instillation
- GLP compliance:
- yes
Test material
- Test material form:
- solid: crystalline
- Details on test material:
- Intended use: Pharmaceutical intermediate
Expiry: 19 November 1995
Purity: 99.6% excluding organic solvents
Appearance: White to off-white crystalline solid
Storage conditions: Room temperature
Date received: 19 May 1995
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source:Interfauna (U.K.) Ltd., Huntingdon, Cambridgeshire, England.
Age:11 to 13 weeks of age
Wright:range of 2.5 to 3.2 kg
Housing:housed individually in metal cages with perforated floors in Building R 14 Room 5.
Diet:A standard laboratory diet SOS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum
Temp:approximately 19°C
Humidity:relative humidity at 30 - 70%.
Acclimation:All rabbits were acclimatised to the experimental environment
Light: lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period
Air Changes: Air exchange was maintained at approximately 19 air changes per hour
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye of each rabbit remained untreated.
- Amount / concentration applied:
- Approximately 50 mg of the test substance, the weight occupying a volume of 0.1 ml, was placed into the lower everted lid of one eye of each animal.
- Duration of treatment / exposure:
- One animal was treated in advance of the others, to ensure that if a severe response was produced, no further animals would be exposed. The eyelids were then gently held together for one second before releasing.
- Observation period (in vivo):
- Examination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4 and 7 days after instillation. Observation of the eyes was aided by the use of a handheld light
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The study was designed to assess eye irritation potential of UK-143, 108 following a single instillation into the eye of the rabbit. The test substance may come into contact with the eye during handling or use.
The study was conducted in compliance with the following guidelines:
EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part B, Method B.5. Acute toxicity (eye irritation).
The albino rabbit was chosen as it has been shown to be a suitable model for eye irritation studies and is the animal recommended in the test guideline.
The amount of test substance instilled was chosen in compliance with the guideline.
The protocol was approved by the Study Director on 27 July 1995, by HRC Management on 30 June 1995 and by the Sponsor on 17 July 1995.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Remarks:
- in vitro score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 0
- Irritant / corrosive response data:
- All rabbits scored 0 for every region of the eye
- Other effects:
- CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the observation period
Any other information on results incl. tables
OCULAR RESPONSES
No corneal damage or iridial inflammation was observed.
Temporary mild conjunctival reactions only were seen.
The eyes were normal one day after instillation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- A single instillation of UK-143,108 into the eye of the rabbit elicited transient mild conjunctival irritation only. All reactions had resolved one day after instillation.
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.
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