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EC number: 401-540-3 | CAS number: 84632-65-5
- 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)
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 97.95 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 18
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 27.78 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
Long-term exposure - systemic effects
An oral subacute toxicity gavage study of CIBA-GEIGY (1986) with a NOAEL of > 1000 mg/kg/day was available.
- Dermal DNEL for long-term exposure - systemic effects
For the determination of the dermal DNEL, the NOAEL of 1000 mg/kg bw/day of the rat oral subacute repeated dose study (CIBA-GEIGY, 1986) was used.
Due to the very low water solubility below 1 mg/L (< 0.499 mg/L at 20 °C) and the absence of skin irritating and sensitizing effects as well as the dermal toxicity data did indicate very low dermal absorption. Therefore, absorption difference was assessed to 50 % comparing the dermal to the oral route. Accordingly, for dermal exposure the corrected starting point was calculated as 2000 mg/kg body weight / day. Using the overall assessment factor of 72, including assessment factors for interspecies extrapolation of 4 (allometric scaling rat to human), intraspecies extrapolation of 3 for worker according to ECETOC 2003, exposure duration of 6 (sub-acute to chronic) and for remaining factors, dose response and quality of database of 1, respectively, the DNEL (Worker) for dermal exposure was calculated as follows: 2000 mg/kg/day/ (4*3*6*1*1*1) = 27.78 mg/kg body weight /day.
- Inhalation DNEL for short-term exposure - systemic effects
Based on the same oral subacute study, the endpoint specific DNEL for inhalation repeated-dose toxicity for workers was calculated using a route to route extrapolation.
The conversion of the rat oral NOAEL of 1000 mg/kg bw/day to a corrected inhalatory human NOAEL was based on the different respiratory volume of the rat (0.38 m³/kg/day and the different rate during light activity at work (10 m³) and standard conditions (6.7 m³).
Corrected NOAEL = 1000 mg/kg * 1/0.38 m³/kg/day * 6.7 m³ (8h) / 10 m³ (8h) = 1763.2 mg/m³/day. Using the overall assessment factor of 18, including assessment factors for intraspecies extrapolation of 3 for worker according to ECETOC 2003, exposure duration of 6 (sub-acute to chronic) and for remaining factors, dose response and quality of database of 1, respectively, the DNEL (Worker) for inhalative exposure was calculated as follows: 1763.2 mg/m³/ (3*6*1*1*1) = 97.95 mg/m³.
The general exposure limit for inhalable dust is applied for local effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20.7 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 30
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.91 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.95 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Long-term exposure - systemic effects
No adverse effects were observed in any study. Based on the available data for 3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione (Cas No. 84632-65-5), the endpoint-specific dermal DNEL was calculated using a No-(Adverse)-Effect-Level of > 1000 mg/kg/day determined in an oral subacute toxicity gavage study (CIBA-GEIGY, 1986)
- Oral DNEL for long-term exposure - systemic effects
Based on the NOAEL of 1000 mg/kg bw/day of the rat oral subacute study, the endpoint specific DNEL for oral repeated-dose toxicity for general population was calculated using the overall assessment factor of 120, including assessment factors for interspecies extrapolation of 4 (allometric scaling rat to human), intraspecies extrapolation of 5 for general polpulation according to ECETOC 2003, exposure duration of 6 (sub-acute to chronic) and for remaining factors, dose response and quality of database of 1, respectively, the DNEL (General population) for oral exposure as follows: 1000 mg/kg/day/ (4*5*6*1*1*1) = 8.33 mg/kg body weight /day.
- Dermal DNEL for long-term exposure - systemic effects
For the determination of the dermal DNEL, the NOAEL of 1000 mg/kg bw/day of the same rat oral subacute repeated dose study (CIBA-GEIGY, 1986) was used.
Due to the very low water solubility below 1 mg/L (< 0.499 mg/L at 20 °C) and the failure of skin irritating and sensitizing effects as well as the dermal toxicity data did indicate very low dermal absorption. Therefore, absorption difference was assessed to 50 % comparing the dermal to the oral route. Accordingly, for dermal exposure the corrected starting point was calculated as 2000 mg/kg body weight / day. Using the overall assessment factor of 120, including assessment factors for interspecies extrapolation of 4 (allometric scaling rat to human), intraspecies extrapolation of 5 for general population according to ECETOC 2003, exposure duration of 6 (sub-acute to chronic) and for remaining factors, dose response and quality of database of 1, respectively, the DNEL (general population) for dermal exposure was calculated as follows: 2000 mg/kg/day/ (4*5*6*1*1*1) = 16.67 mg/kg body weight /day.
- Inhalation DNEL for short-term exposure - systemic effects
Based on the same oral subacute study, the endpoint specific DNEL for inhalation repeated-dose toxicity for workers was calculated using a route to route extrapolation.
The conversion of the rat oral NOAEL of 1000 mg/kg bw/day to a corrected inhalatory human NOAEL was based on the different respiratory volume of the rat (0.38 m³/kg/day and the different rate during light activity at work (10 m³) and standard conditions (6.7 m³).
Corrected NOAEL = 1000 mg/kg * 1/0.38 m³/kg/day * 6.7 m³ (8h) / 10 m³ (8h) = 869.6 mg/m³/day. Using the overall assessment factor of 30, including assessment factors for intraspecies extrapolation of 5 for general population according to ECETOC 2003, exposure duration of 6 (sub-acute to chronic) and for remaining factors, dose response and quality of database of 1, respectively, the DNEL (general population) for inhalative exposure was calculated as follows: 869.6 mg/m³/ (5*6*1*1*1) = 28.99 mg/m³.
The general exposure limit for inhalable dust of 3mg/m3 for the respirable fraction is applied to prevent from dust overload effects.
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.
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