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Diss Factsheets
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EC number: 217-110-1 | CAS number: 1742-95-6
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data is from OECD HPV SIDS
Data source
Reference
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report
- Author:
- ICCA-Initiative
- Year:
- 2 005
- Bibliographic source:
- OECD HPV SIDS, 2005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Acute dermal toxicity of Phthalimide in rabbit
- GLP compliance:
- not specified
- Test type:
- other: No data
- Limit test:
- no
Test material
- Reference substance name:
- Phthalimide
- EC Number:
- 201-603-3
- EC Name:
- Phthalimide
- Cas Number:
- 85-41-6
- IUPAC Name:
- 1H-isoindole-1,3(2H)-dione
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Phthalimide
- Molecular formula (if other than submission substance): C8H5NO2
- Molecular weight (if other than submission substance): 147.13 g/mole
- Substance type: Organic
- Physical state: White crystalline leaflets
Purity 99 %
- Impurities (identity and concentrations): 1 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 2.2 to 2.4 kg males, and 2.2 kg females
Administration / exposure
- Type of coverage:
- other: dermal
- Vehicle:
- corn oil
- Details on dermal exposure:
- VEHICLE
- Concentration in vehicle: 5010 and 7940 mg/kg bw
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: 40% solution-suspension in corn oil
- Lot/batch no. (if required): No data available
- Purity: No data available
MAXIMUM DOSE VOLUME APPLIED: 5010 and 7940 mg/kg bw
DOSAGE PREPARATION (if unusual): 5010 and 7940 mg/kg bw 40% solution-suspension in corn oil
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data available - Duration of exposure:
- 24 hours
- Doses:
- 5010 and 7940 mg/kg bw
- No. of animals per sex per dose:
- Total: 3
5010 mg/kg bw: 1 male
7940 mg/kg bw: 1 male, 1 female - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed:
- Other examinations performed: clinical signs observed. - Statistics:
- No data available
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 940 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No effect on survival and clinical sign
- Mortality:
- No effect on survival of treated male and female rabbits at 7940 mg/kg/day.
- Clinical signs:
- other: Reduced appetite and activity for one to two days were observed in treated rabbits. The viscera appeared normal at end of 14 day.
- Gross pathology:
- No data available
- Other findings:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 was considered to be > 7940 mg/kg/day when New Zealand white male and female rabbits were treated with Phthalimide by dermal application.
- Executive summary:
In acute toxicity study,New Zealand white 2 male and 1 female rabbits were treated with Phthalimidein the concentration of5010 and 7940 mg/kg bw40% solution-suspension in corn oilby dermal application and observed for 14 days. No effect on survival of treatedmale and female rabbits were observed at 5010 and 7940 mg/kg bw. Reduced appetite and activity for one to two days were observed in treated rabbits. The viscera appeared normal at end of 14 day.Therefore, LD50 was considered to be> 7940 mg/kg/day when New Zealand white male and female rabbits were treated with Phthalimide by dermal application.
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