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Diss Factsheets
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EC number: 413-920-6 | CAS number: 88949-33-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 413-920-6
- EC Name:
- -
- Cas Number:
- 88949-33-1
- Molecular formula:
- C30 H20 N2 O2
- IUPAC Name:
- 3,6-bis({[1,1'-biphenyl]-4-yl})-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Substance type: Organic
- Physical state: Solid
- Lot/batch No.: Z-2281/1,2,4,5
- Expiration date of the lot/batch: April 01, 1997
- Storage condition of test material: at room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: Approx. 9 weeks
- Weight at study initiation: males: 235 to 287 g, females: 181 to 213 g
- Fasting period before study: overnight
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1993-01-14 To: 1993-01-28
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: on the back of the animal
- coverage: 25 cm^2 (5x5 cm) for males and 18 cm^2 (3.5x5 cm) for females
- Amount(s) applied (volume or weight with unit): 10 ml/kg body weight
- Type of wrap if used: application on a gauze patch fixed successively to aluminium foil and flexible bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): substance was removed with tissue moistened with tap-water
- Time after start of exposure: 24h
TEST MATERIAL
- Concentration (if solution): 10 ml/kg body weight
- Constant volume or concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily (mortality, viability), once daily (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (daily)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: No clinical signs of ill health or behavioural changes were observed during the study period.
- Gross pathology:
- Macroscopic post mortem examination of the aniraals at termination did not reveal any abnormalities.
- Other findings:
- The treated skin area of all animals was discoloured red by the test substance during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value of the test substance in Wistar rats of either sex was established as exceeding 2000 mg/kg body weight.
- Executive summary:
A GLP conform study was performed with the test substance (purity 97.5%) to assess the acute dermal toxicity in rats according to OECD guideline 402. The test substance dissolved in polyethylene glycol was administered to the skin of five Wistar rats of each sex by semi-occlusive application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. Red staining of the treated skin and/or head, noted among all animals, were considered to be related to staining properties of the test substance. Therefore, the dermal LD50 value of the test substance in Wistar rats of either sex was established as exceeding 2000 mg/kg body weight.
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