Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 416-250-2 | CAS number: 84632-59-7
- 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:
- key study
- Study period:
- 1998-11-17 - 1998-12-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 402) performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted on 24th February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Testing Methods for New Chemical Substances according to the Revised Japanese Chemical Substance Law (March 31, 1987)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 416-250-2
- EC Name:
- -
- Cas Number:
- 84632-59-7
- Molecular formula:
- C26 H28 N2 O2
- IUPAC Name:
- 3,6-bis(4-tert-butylphenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd, Füllinsdorf, Switzerland
- Age at study initiation: Males 10 weeks, Females 11 weeks
- Body weight at study initiation: 283.9 – 292.7 g (males), 200.1 – 213.6 g (females)
- Housing:
- 5 animals/sex/cage in Makrolon type-4 cages, standardized softwood bedding (acclimatization)
- individually in Makrolon type-3 cages (treatment and observation period)
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet (Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum
- Water: Community tap-water from Füllinsdorf, ad libitum
- Acclimation period: at least 7 days (only animals without any visible signs of illness were used for the study)
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 40 – 70 %
- Air changes: 10-15 air changes/hour
- Photoperiod: 12-hour fluorescent light/12-hours dark cycle, music during the light period
IN-LIFE DATES:
From: 1993-11-24 To: 1993-12-08
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Backs of the animals
- Coverage: Approximately 10 % of the total body surface
- On test day 1, the test item was applied evenly on the intact skin with a syringe and covered with a semi-occlusive dressing
- Type of wrap: Dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: The skin was flushed with lukewarm tap water and dried.
TEST MATERIAL
- Amount applied: 500 mg/mL
- Constant volume or concentration used: Yes, 4 mL/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality/Viability: Four times during test day 1 (according to the raw data the last check was conducted 5 hours after application), and once daily during days 2 - 15
- Frequency of observations (clinical signs): Each animal was examined for changes in behaviour and appearance (with special emphasis on the application area, except for time interval of semi-occlusive dressing) four times during day 1, and once daily during days 2-15. All abnormalities were recorded.
- Frequency of weighing: On test days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes, the animals were examined macroscopically and all abnormalities recorded
- Dose formulation: The test item was placed into a glass beaker on a balance and the vehicle (corn oil) was added. A weight by volume dilution was prepared using a homogenizer. Homogeneity of the test item in the vehicle was maintained during treatment using a magnetic stirrer. The preparation was made shortly prior to dosing.
- Rationale for route of exposure: Dermal administration was used as this is one possible route of human exposure during manufacture, handling and use of the test item. - Statistics:
- No statistical analysis was used. The LOGIT-Model could not be applied, since no deaths occurred.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study period.
- Clinical signs:
- other: No clinical signs of systemic toxicity were observed in any animals during the observation period.
- Gross pathology:
- The macroscopic examination at study termination revealed no organ abnormalities.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.