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EC number: 231-175-3 | CAS number: 7440-66-6
- 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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: key study carried out according to OECD guideline
no 401 indicating for zinc metal LD50 > 2000 mg/kg bw
Acute inhalation toxicity: key study carried out according to OECD
guideline no 403 indicating for zinc metal LC50 > 5.41 mg/L/4hrs
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- used in EU risk assessment report for Zinc metal
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no further details provided
- Route of administration:
- oral: feed
- Vehicle:
- maize oil
- Details on oral exposure:
- In this study very fine zinc powder, labelled as “Zincstaub, superfein 620”, was given as a suspension in maize oil
- Doses:
- one dose of 2000 mg zinc/kg bw
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- no further information
- Statistics:
- no information
- Preliminary study:
- no information
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality observed
- Clinical signs:
- other: piloerection in all females, diarrhoea in one female
- Gross pathology:
- no adverse effects reported
- Other findings:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 >2000 mg/kg bw
- Executive summary:
A limit study with Wistar rats was carried out according to OECD guideline no. 401 to assess the oral LD50. Apart from piloerection in all females and diarrhoea in one female, no mortality or clinical signs were observed after dosing of 2000 mg zinc/kg bw during the 14 day observation period. In this study very fine zinc powder, labelled as “Zincstaub, superfein 620”, was given as a suspension in maize oil. The particle size was not given in this study, but according to the accompanying letter from the industry the particle diameter was 5 μm. An LD50-value of > 2000 mg/kg bw was reported
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: no data
- Details on inhalation exposure:
- Of the particles, 85% had an aerodynamic diameter ≤8.2 μm and 27% ≤5 μm. The mass median aerodynamic diameter was determined to be 6.2 μm with a geometric standard deviation of 1.7.
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- ca. 4 h
- Concentrations:
- > 5.41 g Zn/m3 air (the highest attainable concentration)
- No. of animals per sex per dose:
- according to guideline study
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: as per guideline
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: yes - Statistics:
- as per guideline
- Preliminary study:
- no information
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 410 mg/m³ air
- Mortality:
- No mortalities occurred during the 14-day observation period.
- Clinical signs:
- other: visually decreased breathing rate (first 2 days) and sluggishness in all animals (only shortly after exposure) and blepharospasm in two male and two female rats (first day).
- Body weight:
- no information
- Gross pathology:
- Abnormalities at necropsy consisted of lung changes (white spots on three or all five lung lobes) in two males and four females
- Other findings:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LC50 greater than 5.41 g /m3
- Executive summary:
An LC50-value of > 5.41 g /m3air (the highest attainable concentration for the same very fine zinc powder, labelled as “Zincstaub superfein 620”) for a single 4-hour exposure period was found in a nose only exposure study in Wistar rats carried out according to OECD guideline no. 403. Of the particles, 85% had an aerodynamic diameter ≤8.2 μm and 27% ≤5 μm. The mass median aerodynamic diameter was determined to be 6.2 μm with a geometric standard deviation of 1.7. Clinical signs after exposure consisted of visually decreased breathing rate (first 2 days) and sluggishness in all animals (only shortly after exposure) and blepharospasm in two male and two female rats (first day). No mortalities occurred during the 14-day observation period. Abnormalities at necropsy consisted of lung changes (white spots on three or all five lung lobes) in two males and four females.
Reference
none
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 410 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
- Clinical signs:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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
Based on the results of the available acute oral rat study, zinc metal does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).
Based on the results of the available acute inhalation rat study, zinc metal does not require classification for acute inhalation toxicity according to EU CLP criteria (EC 1272/2008).
There are no available data on which to evaluate acute dermal toxicity. However, acute dermal toxicity can be considered low in view of the poor absorption by this route and the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route. Therefore, zinc metal does not require classification for acute dermal toxicity according to EU CLP criteria (EC 1272/2008)
No clear evidence of specific target organ toxicity was noted. As such, classification for STOT-SE is not considered appropriate.
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