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EC number: 412-640-1 | CAS number: 84632-50-8
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-06-24 to 1993-03-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant 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:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- adopted Sep. 19, 1984
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 412-640-1
- EC Name:
- -
- Cas Number:
- 84632-50-8
- Molecular formula:
- C20 H10 N4 O2
- IUPAC Name:
- 3-[4-(3-cyanophenyl)-3,6-dioxo-2H,3H,5H,6H-pyrrolo[3,4-c]pyrrol-1-yl]benzonitrile
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Appearance: orange powder
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: four to seven weeks
- Weight at study initiation: 110 to 120 g
- Fasting period before study: yes
- Housing: in groups of five according to sex in metal cages with wire mesh floors
- Diet: standard laboratory rodent diet (Biosure LAD 1) ad libitum
- Water: drinking water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 22°C
- Humidity: 49% (daily mean)
- Air changes: approximately 10 - 15 per hour
- Photoperiod: 12 hours artificial light (0700 - 1900 hours) in each 24-hour period
IN-LIFE DATES: From: 1993-01-19 To: 1993-02-04
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
A 25% w/v suspension of test item was prepared on the day of dosing in 1 % w/v aqueous methylcellulose.
VEHICLE
- Concentration in vehicle: 1 %
- Amount of vehicle: 20 mL / kg bw / day - Doses:
- 2.5 g / kg bw (preliminary study)
5 g / kg bw (main study) - No. of animals per sex per dose:
- 2 males and 2 females (preliminary study)
5 males and 5 females (main study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Cage side observations: at least twice daily
- Clincal signs: soon after dosing and at frequent intervals for a period of 7 hours. On subsequent days once in the morning and at the end of the experimental day.
- Body weight: on Days 1 (prior to dosing), 8 and 15
- Necropsy of survivors performed: yes - Statistics:
- No
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths following a single oral dose of test item.
- Clinical signs:
- other: Pilo-erection was observed in all rats within four minutes of dosing and throughout the remainder of Day 1. Recovery of all rats, as judged by external appearance and behaviour, was complete by Day 2. Orange/brown faeces were observed on Day 2 only.
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed on Day 15.
Any other information on results incl. tables
Results of preliminary study:
The acute lethal oral dose of the test item to male and female rats was greater than 2.5 g/kg bodyweight.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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