Registration Dossier
Registration Dossier
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EC number: 201-250-5 | CAS number: 80-09-1
- 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

Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.025 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.55 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.003 mg/L
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 20 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 1.74 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.174 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:
- PNEC soil
- PNEC value:
- 0.332 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
Conclusion on classification
Acute data from fish and algae indicate L(E)C50 values for 4,4 -sulphonyldiphenol greater than 100 mg/L. The EC50 obtained for Daphnia is 55 mg/L, the NOEC obtained from a chronic toxicity study to aquatic invertebrates is 2.7 mg/L. The substance is not readily biodegradable and has no potential for bioaccumulation.
Considering the available data on the aquatic toxicity of 4,4 -sulphonyldiphenol as well as its fate properties, and taking into account the provisions laid down in REGULATION (EC) No 1272/2008 (CLP), there is no need to classify the substance for environmental hazards.
In the ZEOGRT study performed for 4,4 -sulphonyldiphenol, an unusually wide spacing factor has been chosen in agreement with the competent authorities. This was necessary to investigate potential endocrine effect of the test substance in the widest possible concentration range. In this respect, the approach taken was also useful and successful: the study clearly demonstrates that 4,4 -sulphonyldiphenol has no hormone-mediated effects on fish.
Furthermore, it has to be noted that a very minor effect (a significant, but slight decrease in body length in male animals of the F1 generation) has led to the determination of the LOEC at a concentration of 1.25 mg/L. Per definition, the next lower concentration is the NOEC, which is 0.25 mg/L in the current study. In fact, however, the study actually does not allow for the assessment of any possible effect in the concentration range between 0.25-1.25 mg/L. From the wide concentration spacing (chosen for the above reasons), a wide range of uncertainty arises here, which particularly covers the classification threshold of 1 mg/L. Due to the very mild effect observed at 1.25 mg/L, it can be reasonably assumed that the actual no effect concentration is close to this tested concentration, and possibly above 1 mg/L. Accordingly, from the perspective of the registrants, the NOEC obtained from the ZEOGRT study is not directly suitable for deriving the chronic classification of the registration item. For this reason, the Registrants are currently discussing the option of submitting a Testing proposal to precisely determine the chronic aquatic NOEC for 4,4 -sulphonyldiphenol by conducting an additional study using a targeted test design including, in particular, a narrow spacing around the classification threshold of 1 mg/L.
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