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Diss Factsheets
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EC number: 910-427-2 | 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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: key studies carried out according to OECD guideline no 401 or 423 indicating LD50 > 2000 mg/kg bw
Acute inhalation toxicity: key study carried out according to OECD guideline no 403 indicating LC50 > 5.7 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance Zinc peroxide and the source substances Zinc oxide, Zinc Chloride, Zinc sulfate, Zinc nitrate are ionic and consist of the Zinc2+ cation and the respective anion.
The read-across is based on the assumption that the zinc cation (as measure for dissolved zinc species) is the determining factor for (eco)toxicity.
For further details, see Justification for read-across attached to IUCLID chapter 13
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See Justification for read-across attached to IUCLID chapter 13
3. ANALOGUE APPROACH JUSTIFICATION
See Justification for read-across attached to IUCLID chapter 13
4. DATA MATRIX
See Justification for read-across attached to IUCLID chapter 13 - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- act. ingr.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of Zinc Peroxide in rat is >/=2000 mg/kg bw.
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance Zinc peroxide and the source substances Zinc oxide, Zinc Chloride, Zinc sulfate, Zinc nitrate are ionic and consist of the Zinc2+ cation and the respective anion.
The read-across is based on the assumption that the zinc cation (as measure for dissolved zinc species) is the determining factor for (eco)toxicity.
For further details, see Justification for read-across attached to IUCLID chapter 13
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See Justification for read-across attached to IUCLID chapter 13
3. ANALOGUE APPROACH JUSTIFICATION
See Justification for read-across attached to IUCLID chapter 13
4. DATA MATRIX
See Justification for read-across attached to IUCLID chapter 13 - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- LC50
- Effect level:
- >= 5 700 mg/L air
- Based on:
- act. ingr.
- Exp. duration:
- 4 h
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The 4 h LC50 of Zinc peroxide is >5.7 mg/L.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 700 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No acute toxicity data are available for the target substance Zinc peroxide. However, reliable data are available for Zinc compounds as well as on hydrogen peroxide. A justification for read-across is attached to IUCLID section 13.
Acute oral toxicity
Data on Zinc
In an acute toxicity test Wistar rats (5/sex) were given a single dose of 5 g ZnO/kg bw (in water) by gavage and observed for 14 days. No mortality and signs of toxicity were observed. The LD50 in rats is therefore >5 g ZnO/kg bw.
Several other studies conducted with ZnO reported LD50 values well above 2000 mg/kg bw in rats or mice.
Data on hydrogen peroxide
“The oral LD50 values or lethal doses in rats range between 800 mg/kg for 70% H2O2 to more than 5,000 mg/kg for 10% H2O2. There are also a number of reported human incidents by oral
ingestion of H2O2 water solutions, but few reports have given data on the dose. The mechanism of systemic effect has been oxygen embolism. Thus, the substance proved to be harmful if swallowed by a physical mode of action.” (EU RAR, 2003)
In the transformation/dissolution test conducted with the target source Zinc peroxide, it was demonstrated, that only low levels of hydrogen peroxide are released. Thus, bolus or high concentration effects of hydrogen peroxide are not relevant for the target substance.
Overall, it can be concluded with sufficient reliability, that Zinc peroxide is of low acute toxicity by oral route (LD50 >2000 mg/kg bw).
Acute dermal toxicity
The testing of acute dermal toxicity of Zinc peroxide is scientifically not justified based on retrospective data analyses undertaken by Creton et al. (2010) and Seidle et al. (2010) to ascertain the value of regulatory requirements prescribing multiroute testing for acute systemic toxicity. These analyses have examined the concordance among regulatory classifications for acute oral, dermal, and/ or inhalation toxicity for ~500 agrochemical and biocidal active substances and nearly 2000 industrial chemicals. The findings from these two independent reviews have revealed that acute dermal studies of pure substances do not add value above and beyond oral data for hazard classification of pesticides, biocides, or chemicals. According to the COMMISSION REGULATION (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin corrosion/irritation, serious eye damage/eye irritation, skin sensitisation and acute toxicity, recent “scientific analysis of available data from in vivo acute toxicity studies have shown that substances that are not toxic via the oral route may be expected with high certainty to be also non-toxic via the dermal route. Therefore, testing those substances via the dermal route does not provide essential information for their safety assessment.” The oral LD50 was determined to be > 2000 mg/kg bw based on read-across from a closely related substance. Thus, no toxicity via the dermal route is to be expected.
Acute inhalation toxicity
Data on Zinc
In an acute inhalation toxicity study, 10 male and 10 female animals per group were exposed to zinc oxide aerosol (head and nose only) for 4 h. Aerosol concentration was 5.7 mg/l and the particle size distribution had a mass median aerodynamic diameter of 4mm ± 2.9 (GSD). Only one concentration and a control group were tested. All animals survived up to day 14 post exposure. Apart from a dusty fur on the head the day after the exposure, no effects were seen. Body weights developed normally. At pathological examination all organs were normal. The LC50 was >5.7 mg/l.
Data on hydrogen peroxide
“Acute inhalation toxicity studies have been performed with aerosols (mice) and vapours (rats and mice). Due to the corrosive nature of the substance after inhalation exposures to highly concentrated aerosols (70% H2O2 as “droplets”), lethality occurs at quite low air concentrations of this substance (0,92-2 mg/l). The lethal event can be attributed to the substance corrosivity rather than its systemic toxicity.” (EU RAR, 2003)
In the transformation/dissolution test conducted with the target source Zinc peroxide, it was demonstrated, that only low levels of hydrogen peroxide are released. Thus, bolus or high concentration effects of hydrogen peroxide are not relevant for the target substance.
Overall, it can be concluded with sufficient reliability, that Zinc peroxide is of low acute toxicity via inhalation (LC50 >5000 mg/m³).
References:
Creton S. et al. Acute toxicity testing of chemicals—Opportunities to avoid redundant testing and use alternative approaches, Critical Reviews in Toxicology, 2010; 40(1): 50–83
EU RAR, 2003.European Union Risk Assessment Report. Hydrogen Peroxide. Volume 38. EUR 20844 EN
Seidle T. et al.: Cross-Sector Review of Drivers and Available 3Rs Approaches for Acute Systemic Toxicity Testing, TOXICOLOGICAL SCIENCES 116(2), 382–396 (2010).
Justification for classification or non-classification
Based on the available data, Zinc peroxide is of low acute, dermal and inhalation toxicity not requiring classification and labelling for acute toxicity according to the CLP Regulation (EC) No 1272/2008.
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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