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EC number: 603-689-1 | CAS number: 132961-05-8
- 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:
- 1991-09-25 to 1991-09-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(2-{4-[(Z)-(2,4-DIFLUOROPHENYL)(HYDROXYIMINO)METHYL]PIPERIDIN-1-YL}ETHYL)-2-METHYL-6,7,8,9-TETRAHYDRO-4H-PYRIDO[1,2-A]PYRIMIDIN-4-ONE
- EC Number:
- 603-689-1
- Cas Number:
- 132961-05-8
- Molecular formula:
- C23H28F2N4O2
- IUPAC Name:
- 3-(2-{4-[(Z)-(2,4-DIFLUOROPHENYL)(HYDROXYIMINO)METHYL]PIPERIDIN-1-YL}ETHYL)-2-METHYL-6,7,8,9-TETRAHYDRO-4H-PYRIDO[1,2-A]PYRIMIDIN-4-ONE
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Analytical purity: Base titration revealed 99.8% (w/w) and acid titration revealed 101.6% (w/w).
- Lot/batch No.: BEA011
- Storage condition of test material: at room temperature in closed containers
- Other: The test substance was prepared in Janssen Research Foundation laboratories and passed the specifications of the chemical quality control
department.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Cunistar-MDL albino rabbits
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: established stock-farm of Buyens, Lichtaart, Belgium
- Age at study initiation: adult
- Weight at study initiation: ranged between 2.350 and 2.630 kg
- Housing: The rabbits were housed in an air-conditioned room in individual metallic cages. The cages consisted of stainless steel walls and a
wire mesh bottom and front door. The cages were suspended in racks above stainless steel drains with scrapers and sink holes for the collection of faeces and urine.
- Diet: The food consisted of Huybrechts pelleted rabbit food, administered in self-raising hoppers and fed ad libitum throughout the study. The diet met all the nutritional requirements of the test system with guaranteed analysis by the manufacturer.
- Water: free and continuous access to fresh tap-water administered via automatic drinking nipples
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 0.1 grams/rabbit administered once in the left conjunctival sac
- Concentration: not applicable
VEHICLE: not applicable - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 3 days, at timepoints: 1, 24, 48, and 72 hours after exposure
- Number of animals or in vitro replicates:
- Three females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: no data
SCORING SYSTEM: Draize
SCORING SYSTEM:
- Draize
TOOL USED TO ASSESS SCORE:
- see below for measures used in calculating eye irritation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- It was concluded that T 1624, when given to albino rabbits at a single dose of 0.1 g/rabbit by ocular application, produced no eye irritation. The erythema and chemosis noted 1 hour after conjunctival application was no longer present at 24 hours.
During grading, moderate erythema was noted in all rabbits (Draize grading = 2, max 3) 1 hour after conjunctival application, whereas rabbit No.3 also showed slight chemosis (Draize grading = 1, max 4) 1 hour after application. These observations were no longer present at 24 hours. The grading scores for corneal opacity, opacity area, iris, and conjunctiva discharge were 0 at 1 hour. Individual scores were 0 at 1, 24, 48, and 72 hours in all rabbits for the cornea, iris and conjunctiva. The overall irritation index was calculated to be 0.00 and evaluated as no eye irritation. - Other effects:
- Body weight remained normal in the rabbits during the 3-day observation period.
Any other information on results incl. tables
Table 1. |
Individual grading of eye irritation in rabbits |
||||
|
|
Score after |
|||
|
|
1 h |
24 h |
48 h |
72 h |
Rabbit No. 1 |
|||||
Cornea |
opacity |
0 |
0 |
0 |
0 |
area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva |
|||||
redness |
2 |
0 |
0 |
0 |
|
chemosis |
0 |
0 |
0 |
0 |
|
|
discharge |
0 |
0 |
0 |
0 |
Rabbit No. 2 |
|||||
Cornea |
opacity |
0 |
0 |
0 |
0 |
area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva |
|||||
redness |
2 |
0 |
0 |
0 |
|
chemosis |
0 |
0 |
0 |
0 |
|
|
discharge |
0 |
0 |
0 |
0 |
Rabbit No. 3 |
|||||
Cornea |
opacity |
0 |
0 |
0 |
0 |
area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva |
|||||
redness |
2 |
0 |
0 |
0 |
|
chemosis |
1 |
0 |
0 |
0 |
|
|
discharge |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It was concluded that T 1624, when given to albino rabbits at a single dose of 0.1 g/rabbit by ocular application, produced no eye irritation. The erythema and chemosis noted 1 hour after conjunctival application was no longer present at 24 hours. The test item is therefore considered not to be classified.
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