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EC number: 917-473-2 | CAS number: 188416-34-4
- 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:
- From 3 to 24 June 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and 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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 188416- 34-4
- IUPAC Name:
- 188416- 34-4
- Reference substance name:
- (2RS,3SR)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol (1R)-10- camphorsulphonate
- IUPAC Name:
- (2RS,3SR)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol (1R)-10- camphorsulphonate
- Reference substance name:
- 2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-yl [(1R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl]methanesulfonate
- EC Number:
- 917-473-2
- Cas Number:
- 188416-34-4
- Molecular formula:
- C16H14F3N5O . C10H16O4S
- IUPAC Name:
- 2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-yl [(1R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl]methanesulfonate
- Details on test material:
- - Analytical purity: 96.5%
- Lot/batch No.: 5ABK-003
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna UK Ltd, Huntingdon, Cambridgeshire, England
- Age at study initiation: Approximately 13 weeks of age
- Weight at study initiation: 3.2 kg
- Housing: Housed individually in metal cages with perforated floors
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19℃
- Humidity (%): 30-70%
- Air changes (per hr): Approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hours period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Approximately 84 mg
- Concentration (if solution): - Duration of treatment / exposure:
- Single instillation without washing
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- Due to the low pH of the test material (pH 1.98), one animal was treated in advance of others to ensure that if a severe response was produced, no further animals would be exposed. As a result of the severity of ocular reactions observed, no further animals were treated.
Approximately 84 mg of the test substance, the weight occupying a volume of 0.1 ml, it was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing.
The contralateral eye remained untreated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No reactions
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: Blanching of nictating membrane
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Examination of the eye was made after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after instillation.
The numerical values given to the ocular reactions elicited by this substance are shown below. No iridial inflammation was observed. Corneal opacification (Grade 4) was noted within one hour of dosing.
A diffuse beefy red colouration of the conjunctivae was seen, accompanied by blanching of the nictating membrane and swelling with partial eversion of the eyelids. These responses gradually ameliorated and the eye was normal 21 days after instillation.
Any other information on results incl. tables
There were no signs of toxicity or ill health in any rabbit during the observation period.
Rabbit number and sex |
Region of eye |
One hour |
Day after instillation |
||||||||
1 |
2 |
3 |
4 |
7 |
14 |
21 |
|||||
2885 ♂ |
Cornea |
Density |
4 |
4 |
3 |
3 |
3 |
1 |
0 |
0 |
|
Area |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
|||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness |
2a |
2a |
3a |
3a |
3a |
2 |
2 |
0 |
||
Chemosis |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
0 |
Pilot animal
A Blanching of nictating membrane
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Instillation of the substance into the rabbit eye elicited corneal opacification and moderate conjuntival irritation.
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