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Diss Factsheets
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EC number: 237-057-8 | CAS number: 13597-65-4
- 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
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Endpoint summary
Administrative data
Description of key information
Acute oral and acute inhalation toxicity data are read across from zinc and soluble zinc compounds.
Acute oral toxicity: key studies carried out according to OECD guideline
no 401 or 423 indicating for both micro- and nanomaterial zinc oxide
LD50 > 2000 mg/kg bw
Acute inhalation toxicity: key study carried out according to OECD
guideline no 403 indicating for micro zinc oxide LC50 > 5.7 mg/L/4hrs.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 700 mg/m³ air
Additional information
There are no data available on acute toxicity by oral or inhalation routes for zinc silicate. However, the analysis of the dissolution and bioaccessibility of zinc silicate demonstrated that significant quantities of ionic zinc are released in physiological test media (2.45 - 94.0%) (Martinez 2016a), therefore it is justified to read across the acute toxicity data from zinc oxide and soluble zinc compounds to zinc silicate. See attached justification in IUCLID section 13 for further details.
Acute oral and acute inhalation toxicity data are read across from zinc oxide dossier.
- With Oral LD50values
consistently exceeding 2,000 mg/kg bw, zinc oxide (LD50ranges
between 5,000 and 15,000mg/kg bw), both micro- and nano- zinc oxide
shows a very low level of acute oral toxicity.
- With Inhalation LC50 value > 5.7 mg/L/4hrs, zinc
oxide is shown to be of low
acute inhalation toxicity.
Zinc oxide nanomaterial:
Tests performed specifically on nano-ZnO demonstrate also very low acute oral toxicity (i.e. LD50 values consistently exceeding 2,000 mg/kg bw). The only available inhalation data on nano-ZnO indicates an LC50 value of > 1.79 mg/L. However, only this one single dose of 1.79 mg/L was tested which was the maximum attainable exposure concentration for achieving respirable particle size. Data on nano-ZnO confirms low acute dermal toxicity with LD50>2000 mg/kg bw.
In conclusion, for nano-ZnO no nano-specific acute toxicity could be identified. The Zn2+ion determines the toxicity of ZnO and read across between various forms of ZnO (micro-scale, nano, coated or not) is fully supported.
Of significance for humans from an acute toxicity standpoint is the occurrence of metal fume fever following exposure to ultrafine particles of special grades of zinc oxide in context of very specific operations such as cutting or welding of galvanised steel. Metal fume fever is exclusively associated with freshly formed ultrafine particulate zinc oxide (<0.1 µm). As these ultrafine particles (nanoparticles) rapidly agglomerate to bigger particles, which are normally encountered at production and processing sites, at these sites there is no indication for metal fume fever. According to the response from 11 zinc companies to a questionnaire, there have been no observations of zinc metal fume fever over the last decade and in recent occupational practice (EU RAR, 2004a-f). However in light of responsible care and since no studies are available that allow the establishment of a NOAEL for metal fume fever with a reasonable degree of certainty, a LOAEL (5 mg ZnO/m3) for 2 hours (showed the typical metal fume fever symptoms beginning 4 to 8 hours after exposure and disappearing within 24 hours) can be used for metal fume fever based on the study by Gordon et al.(1992).
Justification for classification or non-classification
Zinc oxide (micro- and nano-material) is of low acute oral and inhalation toxicity, not requiring a classification for acute toxicity according to the EC criteria.
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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