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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 May 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- This study was performed to assess the skin sensitisation potential of CP-89,575 using the guinea-pig. The method foiiowed was that described in:EEC Methods for the determination of toxicity, Annex of Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part B, Method B.6. Skin sensitisation.
MAGNUSSON, B. and KLIGMAN, A.M. (1970) Allergic Contact Dermatitis in the Guinea pig: Identification of contact allergens, Thomas, C.C., Springfield, Illinois, U.S.A.
Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected:
Intradermal injection: 1% w/v in Alembicol D
Topical application: 50% w/v in Alembicol D
Challenge application: 50% and 25% w/v in Alembicol D
Ten test and five control guinea-pigs were used in this study. - GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA method was not available in 1997 when this study was conducted.
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:
- other: solid
- Details on test material:
- Purity: 99.9%
Appearance: Off-white solid
Storage conditions: Room temperature in the dark
Date received: 2 February 1996
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:D. Hall, Newchurch, Staffordshire, England.
- Age at study initiation: approximately four to five weeks of age.
- Weight at study initiation: weight range of 288 to 367 g on arrival
- Housing:The guinea-pigs were housed in groups of five in suspended metal cages with wire mesh floors in Building R 17 Room 14
- Diet (e.g. ad libitum): ad libitum, . Hay was given weekly.The batch of diet used for the study was not analysed for nutrients, possible contaminants or micro organisms.
- Water (e.g. ad libitum):A vitamin C enriched guinea-pig diet FD2 and drinking water were provided ad libitum
- Acclimation period: All the guinea-pigs were acclimatised to the experimental environment for five days prior to allocation to the main study.
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):12/24
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other:
- Concentration / amount:
- Based on the results of the preliminary investigations, the following concentrations of CP-89,575 were selected:
Induction intradermal injection- 1% w/v in Alembicol D
Induction topical application- 50% w/v in Alembicol D
Topical challenge - 50% and 25% w /v in Alembicol D
lnjectables for the test animals were prepared as follows:
1. Freund's complete adjuvant** was diluted with an equal volume of water for irrigation (Ph.Eur.).
2. CP-89,575, 1% w/v in Alembicol D.
3. CP-89,575, 1% w/v in a 50 : 50 mixture of Freund's complete adjuvant and Alembicol D.
A 40 x 60 mm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made into a 20 x 40 mm area within the clipped area
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other:
- Concentration / amount:
- Based on the results of the preliminary investigations, the following concentrations of CP-89,575 were selected:
Induction intradermal injection- 1% w/v in Alembicol D
Induction topical application- 50% w/v in Alembicol D
Topical challenge - 50% and 25% w /v in Alembicol D
lnjectables for the test animals were prepared as follows:
1. Freund's complete adjuvant** was diluted with an equal volume of water for irrigation (Ph.Eur.).
2. CP-89,575, 1% w/v in Alembicol D.
3. CP-89,575, 1% w/v in a 50 : 50 mixture of Freund's complete adjuvant and Alembicol D.
A 40 x 60 mm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made into a 20 x 40 mm area within the clipped area
- No. of animals per dose:
- Number of animals in test group: Ten (Animal Numbers) 950 to 959
Number of animals in negative control group: five control guinea-pigs were used in this study (Animal Numbers) 945 to 949 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 - intadermal and topical
- Exposure period: 9 days total. Injection, 6 days later pretreatment with 10% sodium lauryl sulphare, 24 hrs later patch soaked in 0.4 ml of CP-89,575, 50% w/v in Alembicol D was placed on guinea pig for 48 hours.
- Control group: During the induction phase, the control animals were treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections and topical application
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: challenged topically two weeks after the topical induction application
- Exposure period: 24hr occlusive bandage
- Test groups:
- Control group:
- Site:left flank control; right flank test substance
- Concentrations:
- Evaluation (hr after challenge):24 and 48 hr after treatment- local reaction (erythema, edema)
OTHER: - Challenge controls:
- no data
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other:
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Remarks on result:
- other: Reading: other:. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded. .
- Reading:
- other:
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Remarks on result:
- other: Reading: other:. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded. .
Any other information on results incl. tables
Intradermal injections :
Necrosis was recorded at sites receiving Freund's Complete Adjuvant in test and control animals. Slight irritation was seen in test animals at sites receiving CP-89,575, I% w/v in Alembicol D and slight irritation was observed in control animals receiving Alembicol D.
Topical application :
Slight erythema was observed in test animals following topical application with CP-89,575, 50% w/v in Alembicol D. Slight erythema was seen in the control guinea-pigs
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In this study, CP-89,575 did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals
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