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EC number: 421-320-0 | CAS number: 118289-55-7 CP-89,575
- 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:
- 9/28/92 - 9/30/92
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study followed FHSA Guidelines, CFR Title 16, Section 1500.42 (US Federal Hazardous Substances Act). Study was conducted according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA Guidelines, CFR Title 16, Section 1500.42 (US Federal Hazardous Substances Act).
- Principles of method if other than guideline:
- A representative sample of test material (26.6 mg), equivalent to a volume of approximately 0.1 ml of CP-89,575 powder, was introduced into the conjunctival sac of the left eye; the right eye of each animal served as an untreated control. The treated eye of each rabbit was not rinsed after dosing. The animals were observed for clinical signs for 4 days and were weighed daily. On the day of dosing (day 1), the eyes were evaluated with minimal manipulation and without the use of fluorescein. Eyes were also evaluated 24, 48, and 72 hours after dosing.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one
- EC Number:
- 421-320-0
- EC Name:
- 6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one
- Cas Number:
- 118289-55-7
- Molecular formula:
- Hill formula: C10 H9 Cl2 N O CAS formula: C10 H9 Cl2 N O
- IUPAC Name:
- 6-chloro-5-(2-chloroethyl)-2,3-dihydro-1H-indol-2-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- DESCRIPTION: A fine, orangish-brown powder with white flecks
MOLECULAR FORMULA: C1oH9Cl2NO
MOLECULAR WEIGHT: 230.09
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- SPECIES: Albino Rabbit (New Zealand White)
SOURCE: Millbrook Farm
SEX: 1 Male, 2 Females
WEIGHT RANGE: 2.86 to 3.02 kg
Test system
- Vehicle:
- not specified
- Controls:
- other: Untreated right eye was used as control
- Amount / concentration applied:
- 26.2 MG
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- The animals were observed for clinical signs for 4 days and were weighed daily. On the day of dosing (day 1), the eyes were evaluated with minimal manipulation and without the use of fluorescein. Eyes were also evaluated 24, 48, and 72 hours after dosing
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The animals were dosed on 10/14/92 and euthanized by intravenous sodium pentobarbital overdose on 10/17/92. The purity (activity) of the compound (95.6%) was not taken into consideration, and the stability of the test article under the conditions of the study was not determined.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 2 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 73 hrs
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- At 2 hours after dosing. a small amount of what appeared to be the test article, slight reddening (score= 1) of the palpebral conjunctivae, and slight chemosis (score= 1) were apparent in the treated eye of each animal. In addition, a small amount of discharge (score
= 1) was evident in the treated eye of Rabbit #2 and 3.
By 4 hours after dosing, slight circumcomeal reddening was apparent in each of the treated eyes, the degree of conjunctiva! reddening in Rabbit #3 had increased (score= 2), and the discharge in the eye of Rabbit #2 had subsided.
At 24 hours after dosing, the treated eye of two of the three rabbits(# 1 and 2) appeared essentially normal, while only slight reddening of the conjunctivae (score = 1) and slight
circumcorneal reddening were noted in the other animal. The integrity of the corneal epithelium was confirmed at 24 hours with the aid of fluorescein. When examined at 48 and 72 hours after dosing, each of the treated eyes appeared normal. - Other effects:
- The untreated control eye of each animal was normal and unchanged throughout the test period.
All rabbits remained asymptomatic during the test period, and there was no effect on food consumption or body weight
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The results of this study indicate that CP-89,575 is not an ocular irritant in albino rabbits when tested according to FHSA guidelines (16 CFR 1500.42) because a positive reaction was not apparent in any of the treated eyes 24, 48, or 72 hours after the instillation of a single dose of 26.6 mg of the compound.
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