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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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: This test should be used viewed on a weight of evidence approach as not OECD method. But it was completed per GLP and according to 49 Code of Federal Regulations 173:132 (USA) (US Department of Transport Protocol).
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: 49 Code of Federal Regulations 173:132 (USA) (US Department of Transport Protocol).
- Principles of method if other than guideline:
- A single dose of 2000 mg of CP-89,575/kg was applied to an approximately 240 cm2 (15 x 16 cm) area of intact skin that was premoistened with normal saline. The test material was held in continuous contact with the skin under an occlusive dressing for 24 hours. The rabbits were observed for clinical signs of toxicity and gross skin changes at
least once daily for 2 days after dosing and were weighed daily. Each animal was identified with a unique ear tattoo number and each cage was labeled with a card containing all
pertinent study information. The animals were dosed on 9/28/92 {day 1) and euthanized by intravenous sodium pentobarbital overdose on 9/'30/92 {day 3). - 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: C10H9Cl2NO MOLECULAR WEIGHT: 230.09
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- SOURCE: Millbrook Farm
SEX: 3 Males, 2 Females
WEIGHT RANGE: 3.13 to 3.44 kg
The rabbits were observed for clinical signs of toxicity and gross skin changes at
least once daily for 2 days after dosing and were weighed daily. Each animal was identified with a unique ear tattoo number and each cage was labeled with a card containing all
pertinent study information.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: The test area was pre-moistened with normal saline.
- Controls:
- no
- Amount / concentration applied:
- 2000 mg
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 2 days
- Number of animals:
- 5
- Details on study design:
- A single dose of 2000 mg of CP-89,575/kg was applied to an approximately 240 cm2 (15 x 16 cm) area of intact skin that was premoistened with normal saline. The test material was held in continuous contact with the skin under an occlusive dressing for 24 hours. The rabbits were observed for clinical signs of toxicity and gross skin changes at least once daily for 2 days after dosing and were weighed daily. Each animal was identified with a unique ear tattoo number and each cage was labeled with a card containing all pertinent study information.
The animals were dosed on 9/28/92 {day 1) and euthanized by intravenous sodium pentobarbital overdose on 9/'30/92 {day 3). Doses were calculated on a weight basis (i.e., mg of compound as supplied/kg); the purity (activity) of the compound (95.6%) was not taken into consideration for dose calculations. The stability of the test article under the conditions of the study was not determined.
A standardized scoring system was used to evaluate skin changes at the application site. Draize scoring. (Draize, J. H., Woodard, G., and Calvery, H. 0.: Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes.J. Pharmacol. Exptl. Therap., 82:3n - 390, 1944)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- SKIN CHANGES: No erythema, edema, or other signs of skin irritation were noted in any of the rabbits during the observation period (72 hours)
- Other effects:
- CLINICAL OBSERVATIONS: 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:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Results of this test indicate that because no signs of skin irritation were produced, CP-89,575 is not considered a an irritant.
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