Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 221-110-7 | CAS number: 3006-82-4
- 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

Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.002 mg/L
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.004 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0 mg/L
- Assessment factor:
- 500
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 0.64 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.622 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.062 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- no exposure of soil expected
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
PNEC freshwater sediment:
K_(susp-water) = 81.9
RHO_(susp) = 1150
Conversion factor (wwt -> dwt): 4.6
PNEC_freshwater sediment
= (K_(susp-water)/ RHO_(susp))*PNEC_water * 1000
= (81.9/1150)* 1.9E-03 *1000
= 0.135 mg/kg wwt
= 0.622 mg/kg dw
PNEC marine water sediment:
K_(susp-water) = 81.9
RHO_(susp) = 1150
Conversion factor (wwt -> dwt): 4.6
PNEC_marine water sediment
= (K_(susp-water)/ RHO_(susp))*PNEC_marine water* 1000
= (81.9/1150)*1.9E-04* 1000
= 1,35E-02 mg/kg wwt
= 0.0622 mg/kg dw
Justification for no PNEC soil derivation
Direct and indirect exposure of the test item to soil is highly unlikely. Due to the unstable nature of organic peroxides, it can be assumed that upon contact with soil and organic matter, the test item undergoes rapid degradation resulting in the formation of respective alcohols and acids. Thus, toxicity to soil organisms was considered scientifically not justified.
Further, according to the Guidance on information requirements and chemical safety assessment Chapter R.7.11.5.3, the PEC and PNEC for the terrestrial compartment do not have to be calculated if exposure to soil is negligible. Based on the examples given this is applicable if e.g. potential land spreading or aerial deposition of the substance and other pathways such as irrigation or contact with contaminated waste can be considered unlikely.
Taking the complete life cycle of this substance into careful consideration including the risk management measures in place, these qualifications are fulfilled.
This is confirmed by the following argumentation when looking at the several routes chemicals can reach the soil:
1. Application of sewage sludge in agriculture / land spreading
In general, the release of organic peroxides from the production plant into the sewage is very limited, not to say completely negligible. However, in rare cases when organic peroxides reach the sewage of a plant production or a downstream user’s plant, these are treated with other substances in dedicated industrial sewage treatment plants. The activated sludge stemmed from these industrial sewage treatment plants are further extracted and treated as chemical waste.
The waste water from production plant is treated on site (at least a physical/chemical treatment, which will neutralize potential residual organic peroxide), which is usually followed by a biological treatment. So, it is expected that organic peroxides are not present in sludge. In addition, land spreading of sewage sludge is strictly interdicted. Any sewage sludge has to be disposed e.g. by incineration.
Regarding the rest of the lifecycle, organic peroxides are mainly used as cross-linking agent/polymerization initiator for the production of resins/rubbers/polymers. Based upon the fact that organic peroxides are totally consumed during the process (>99%, which is confirmed by the release factor to sewage for curing agents from ESD n°3), the soil is not exposed to organic peroxides via use of sludge.
As a consequence, exposure of soil to organic peroxides via the application of sewage sludge in agriculture can be excluded.
2. Direct application of chemicals
Based on the uses inventoried for organic peroxides there is no direct application of these substances on the soil compartment. Indeed, all uses are within industrial settings.
3. Deposition via other pathways such as irrigation or contact with contaminated waste
Contact with contaminated waste or deposition via e.g. irrigation processes is negligible. Any waste from production plant is treated on site and the organic peroxides are totally consumed during the industrial end uses. In addition, there are risk management measures in place to control the deposition via any other pathways such as irrigation. In case contamination takes place, the waste water is disposed e.g. via STP with high efficiency or incineration (see also 1. above).
4. Deposition from the atmosphere / aerial deposition of the substance
Deposition from the atmospheric compartment involves volatilization, vaporization or direct release of a considered substance into the atmosphere. Due to their dangerous intrinsic physico-chemical properties, organic peroxides are carefully handled in (semi-)closed systems and their transport, production and use are ruled by several regulations. This is also in line with the release factor to atmosphere for curing agents from ESD n°3. Based on organic peroxides uses, deposition on soil from the atmosphere is also not expected. In addition,dedicated equipment with high efficiency requiring only minor cleaning processes is implemented to prevent aerial deposition of the substance (e.g. adsorption units, off-gas cleaning, air-filtration using high efficiency air filter, waste gas membrane separation, biological treatment, thermal treatment, etc.).
Based on these arguments any exposure to soil is highly unlikely and is considered negligible. No test is proposed for the soil compartment. Further, as the criteria to waive the derivation of both PEC and PNEC for the soil compartment are fulfilled, these effect concentrations have not been calculated.
Conclusion on classification
Acute toxicity:
Algae is the most sensitive species to the acute toxic effects of the test item with an acute ErC50 of 0.4394 mg/L. Based on the these data, the substance has to be classified with regard to acute environmental toxicity as acute aquatic cat.1 (H400: Very toxic to aquatic life, M=1) according to Regulation (EC) No 1272/2008 (CLP/GHS).
Chronic toxicity:
Algae are the most sensitive species to toxic long term effects of the test item with a chronic NOEC of 0.018 mg/L. As the test item is readily biodegradable, on the basis of acute and chronic toxicity data the substance is classified as chronic aquatic cat. 2 (H411: Toxic to aquatic life with long lasting effects) according to Regulation (EC) No 1272/2008 (CLP/GHS).
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