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EC number: 936-276-2 | CAS number: -
- 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
Toxicity to other above-ground organisms
Administrative data
Link to relevant study record(s)
Description of key information
According to transformation/dissolution study (OECD guidance 29) conducted for the target substance, the most biovailable constituent of the target substance is lead. It is also nonessential and the most hazardous constituent in relation to the secondary poisoning. Therefore, the chemical safety assessment focuses on the toxicity of lead and the key value for CSA is selected from lead toxicity studies on mammals and used for the PNEC oral derivation.
Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for mammals:
- 64 mg/kg food
Additional information
Because the target substance is an inorganic solid UVCB substance and insoluble to water, the environmental fate and toxicity is related to the soluble (bioavailable) constituents of the substance. According to the T/D study results conducted for the target substance, the most soluble and critical components of this substance are lead and zinc which appear in the substance in sulphide and sulphate forms. The read-across justification is presented in CSR annex I.
Lead is considered to be the most critical constituent in relation to the bioaccumulation and secondary poisoning for exposure of man via environment. This conclusion is based on the bioaccumulation potential of lead and its nonessential and toxic nature.Zinc is an essential element that is regulated throughout the food chain and does not bioaccumulate/biomagnify.
On the other hand, lead iscarcinogenic, reproduction toxic and causes repeated dose toxicity. It is also the main component and the only readily soluble constituent of the target substance based on the T/D study. In soil, lead has a strong binding capacity to organic matter especially to humic surface soils, and it has bioaccumulation potential to animals and plants. Therefore, the secondary poisoning is focusing on the properties of lead. The exposure assessment and risk characterisation for man via environment focuses on the lead emissions via inhalation and via food consumption. The following read-across data on lead was used to derive the PNEC oral for mammals. For further information on PNEC derivation, see CSR section 7.6.
Toxicity of lead and its compounds
The lowest NOEC for mammals refers to a full chronic study for mammals (Morris et al. 1938), which resulted in a NOEC value of 64 mg Pb/kg ww. Sub-chronic and chronic studies for 3 different mammal species were collected from literature, i.e. for Rattus sp. (different strains), Rattus norvegicus and for mice. For mammal oral toxicity, the values vary between 64 to >12800 mg/kg ww. The lowest value of 64 mg Pb/kg ww (423-d NOEC, Osborn-Mendel rat) was used to derive the PNEC, which was observed in several experiments. According to the guidance, the PNEC oral was calculated from the lowest NOEC oral using an assessment factor.
An assessment factor of 6 has been selected on the lowest toxicity data. Considering a background concentration of 1.3 mg Pb/kg in the food, the PNEC oral can be calculated as: PNEC oral= (NOEC +Cb) /AF = (64+1.3) /6 =10.9 mg/kg food (mammal). This value is further used for risk characterisation purposes.
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.
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