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EC number: 810-682-9 | CAS number: 230615-70-0
- 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:
- 30 October - 08 November 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2,2-trifluoro-1-{5,8,14-triazatetracyclo[10.3.1.0²,¹¹.0⁴,⁹]hexadeca-2,4,6,8,10-pentaen-14-yl}ethan-1-one
- EC Number:
- 810-682-9
- Cas Number:
- 230615-70-0
- Molecular formula:
- C15H12F3N3O
- IUPAC Name:
- 2,2,2-trifluoro-1-{5,8,14-triazatetracyclo[10.3.1.0²,¹¹.0⁴,⁹]hexadeca-2,4,6,8,10-pentaen-14-yl}ethan-1-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- Buff coloured solid or pale brown powder depending on which batch
Storage conditions: room temperature. in the dark
Constituent 1
- Specific details on test material used for the study:
- Buff coloured solid
Storage conditions: room temperature in the dark
Batch number: 53650-10-11
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three New Zealand White rabbits at the start of the study the animals were in the weight range of 2.63 to 3.00 kg
and were twelve to sixteen weeks old. After an acclimatisation period of at least five days each
animal was given a number unique within the study which was written with a black indelible
marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking
water and food (Certified Rabbit Diet (Code 5322) supplied by PMI Nutrition International,
Nottingham. UK) was allowed throughout the study. The diet and drinking water were
considered not to contain any contaminant of a level that might have affected the purpose or
integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70%
respectively. Any occasional deviations from these targets were considered not to have affected
the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per
hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00
to 18:00) and twelve hours darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- A volume of 0.1 ml of the test material, which was found to weigh approximately 60 mg (as measured by gently compacting the required volume into an
adapted syringe) was placed into the conjunctival sac of the right eye formed by gently pulling the lower lid away from the eyeball. - Duration of treatment / exposure:
- The upper and lower eyelids were held together for about one second immediately after treatment to prevent loss of the test material , and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material. an assessment of the initial pain reaction was made according to the six point scale.After consideration of the ocular responses produced in the first treated animal. two additional animals were treated.
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 2, 48, and 72 hours following treatment according to a numerical evaluation. Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope. An additional observation was made on Day 7 to assess the reversibility of the ocular effects.
- Details on study design:
- The numerical values corresponding to each animal. tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness). B (chemosis) and C (discharge). those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
At the end of the study one animal (number 25) was humanely killed and two animals (numbers 97 and 102) were transferred to the pyrogen colony.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 25 Male
- Time point:
- other: 1 hr.
- Score:
- 10
- Max. score:
- 22
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 25 Male
- Time point:
- 24 h
- Score:
- 22
- Max. score:
- 22
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 25 Male
- Time point:
- 48 h
- Score:
- 13
- Max. score:
- 22
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 25 Male
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 22
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 25 Male
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 22
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 97 Female
- Time point:
- other: 1 hr.
- Score:
- 17
- Max. score:
- 17
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 97 Female
- Time point:
- 24 h
- Score:
- 6
- Max. score:
- 17
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 97 Female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 17
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 97 Female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 17
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 97 Female
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 17
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 102 Male
- Time point:
- other: 1 hr.
- Score:
- 17
- Max. score:
- 17
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 102 Male
- Time point:
- 24 h
- Score:
- 13
- Max. score:
- 17
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 102 Male
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 17
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 102 Male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 17
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 102 Male
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 17
- Irritant / corrosive response data:
- Effects were fully reversible within 7 days.
Any other information on results incl. tables
Iridial inflammation was noted in two treated eyes at the 1-hour observation, and persisted in one treated eye and developed in one other treated eye at the 24-hour observation. No other iridial effects were noted.
Moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation with minimal to moderate conjunctival irritation at the 24-hour observation. Minimal to moderate conjunctival irritation was noted in two treated eyes at the 48-hour observation. Minimal conjunctival redness persisted in one treated eye at the 72-hour observation. Residual test material was noted in all treated eyes at the 1-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CP-548,507 produced a maximum group mean score of 14.7 and was classified as a MILD IRRITANT (CLASS 4 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.
- Executive summary:
The test material did not meet the criteria for classification as irritant according, to EU labelling regulations Commission Directive 93 /21/EEC and does not meet the GHS criteria.
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