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EC number: 240-597-7 | CAS number: 16529-65-0
- 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
No acute toxicity studies with zinc didocosanoate are available, thus the acute toxicity will be addressed with existing data on the dissociation products zinc and docosanoic acid. Signs of acute oral toxicity are not expected for zinc ditetradecanoate, since for the moieties zinc and tetradecanoate have not shown signs of acute oral toxicity (LD50 > 2000mg/kg).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Used in EU risk assessment for zinc oxide, limited study details provided
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- 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:
- 5 per sex
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- single dose by oral gavage in water and observed for 14 days
- Doses:
- single dose of 5 gZnO/kg bw
- No. of animals per sex per dose:
- 5 per sex
- Control animals:
- not specified
- Details on study design:
- no further information
- Statistics:
- no data
- Preliminary study:
- no further information
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- no mortality
- Clinical signs:
- no adverse signs of toxicity
- Body weight:
- no adverse signs of toxicity
- Gross pathology:
- no adverse signs of toxicity
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 > 5000 mg ZnO/kg bw was determined.
- Executive summary:
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 LD50for rats is therefore >5 g ZnO/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is well documented and meets general acceptable scientific principle.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- the publication does not specify GLP compliance
- Test type:
- other: limit test
- Limit test:
- yes
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- - Rationale for the selection of the starting dose: Based on the result of another study (Yamaki & Yoshino 2009).
- Doses:
- 5,000 mg/kg bw for both ZnO nanoparticle and microparticle
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes
- Details on study design:
- Thirty mice were divided into three groups (five males and five females per group). Mice were fed with vehicle (control group), 5,000 mg/kg bw ZnO-nanoparticle suspension or 5,000 mg/kg bw ZnO-microparticles suspension. Dosed mice were conditioned for 14 d. The mortality and clinical behaviour were observed daily. Body weights were recorded twice weekly. At the end of the study (on Day 14), the mice were anaesthetised with isoflurane and blood (for serum biochemistry analysis) was collected from the orbital sinus, followed by gross necropsy. Tissue samples (for histopathologic examination) were taken and fixed in 10% neutral buffered formalin
- Statistics:
- All data were expressed as the mean ± SD from at least three independent experiments (N ‡ 3). The significance of the difference between the control and each experimental test condition was analysed by Student’s t-test. Statistically significant differences among groups were determined using one-way analysis of variance (ANOVA). A value of p < 0.05 was taken as statistically significant.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Not observed
- Clinical signs:
- Not observed
- Body weight:
- In comparison with vehicle control group, ZnO microparticles treated group showed a body weight reduction in both males (Days 5 and 10) and females (Days 5, 10, and 14); the body weight changes were unobvious in ZnO nanoparticle treated groups.
- Gross pathology:
- Decreased wet weights of the spleen, kidney, and liver were observed in ZnO microparticles treated females but not in ZnO nanoparticle treated males. However, no obvious gross pathological signs were found in the study.
- Other findings:
- All serum biochemistry measures were without any significant alternation except for marginal variations in certain parameters.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the study details, the LD50 value of both the ZnO nanoparticles and ZnO microparticles can be established at >5,000 mg/kg bw in mice.
- Executive summary:
The study was conducted to examine the acute toxicity of both ZnO nanoparticles and ZnO microparticles in mice.
Thirty mice were divided into three groups (five males and five females per group). Mice were fed with vehicle (control group), 5,000 mg/kg bw ZnO-nanoparticle suspension or 5,000 mg/kg bw ZnO-microparticles suspension. Dosed mice were conditioned for 14 d.
All the mice survived throughout the testing period without exhibiting any abnormalities related to the test substances. In comparison with the vehicle control group, ZnO-microparticles treated group showed a body weight reduction in both males (Days 5 and 10) and females (Days 5, 10, and 14); the body weight changes were not obvious in ZnO-nanoparticle treated groups. All serum biochemistry measures were without any significant alterations except for marginal variations in certain parameters.
Based on the study details, the LD50 value of both the ZnO nanoparticles and ZnO microparticles can be established at >5,000 mg/kg bw in mice.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to the OECD guideline, but mice used
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: CD-ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age: 8 weeks
Weight: 20-22 g - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Doses:
- 1000, 2000, 3000, 4000, 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:before begin of study, after 2 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology, blood analysis - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: 20 nm ZnO
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - < 5 000 mg/kg bw
- Remarks on result:
- other: 120 nm ZnO
- Mortality:
- One female death occurred in the nano-scale 2000 mg group and one male death in the nano-scale 5000 mg group.
As for 120-nm ZnO treated mice, one and three female mice died in the sub-micro 2000 mg and 5000 mg group. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the authors nano-scale as well as submicro-scale ZnO are both not classified according to the GHS with a LD50 of greater than 5 g/kg and 2g/mg < LD50 < 5 g/kg, respectively.
- Executive summary:
In this work, the acute oral toxicity of 20- and 120-nm ZnO powder at doses of 1-, 2-, 3-, 4-, 5-g/kg body weight was evaluated referred to the OECD guidelines for testing of chemicals. As the results, both 20- and 120-nm ZnO belong to non-toxic chemicals according to the Globally Harmonized Classification System (GHS) for the classification of chemicals.
Referenceopen allclose all
none
Combined with the results of zinc accumulation, pathological examination and the biological indicators assays, according to the authors the target organs for 20- and 120-nm ZnO acute oral administration are demonstrated as liver, heart, spleen, pancreas and bone.
The biochemical and pathological investigation shows that the toxic effects between the 20-nm and 120-nm ZnO particles are a little different. For example, the blood viscosity could be induced by low and median dose of 20-nm ZnO but high dose of fine ZnO after oral administration. The edema and degeneration of hepatocytes, and inflammation of pancreas could be observed in most of the 20-nm ZnO treated mice. The 120-nm ZnO treated mice were found having dose-effect pathological damage in gastric, liver, heart and spleen, however, the 20-nm ZnO treated mice presented lessened liver, spleen and pancreas damage with the increase of treated dose.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Zinc didocosanoate
No acute toxicity studies with zinc didocosanoate are available, thus the acute toxicity will be addressed with existing data on the individual moieties zinc and docosanoate.
Signs of acute oral toxicity are not expected for zinc ditetradecanoate, since for the moieties zinc and tetradecanoate have not shown signs of acute oral toxicity (LD50 > 2000mg/kg). Under the assumption that the moieties of zinc didocosanoate show their toxicological profile individually upon dissolution, the acute oral (systemic) toxicity of zinc didocosanoate can be calculated using the equation given in regulation (EC) 1272/2008, Annex I, Section 3.1.3.6.1.
Further, in a supporting study with the analogous substance zinc dilaurate, no toxicity was seen in an acute inhalation toxicity test up to the limit concentration of 5mg/L. Thus, acute toxic effects are not likely to occur. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.
The calculated oral and dermal LD50 for zinc ditetradecanoate is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE).
Zinc
Acute oral toxicity
- With LD50values consistently exceeding 2,000 mg/kg bw, zinc oxide (LD50ranges between 5,000 and 15,000mg/kg bw), shows very low level of acute oral toxicity.
Tetradecanoate
Acute oral toxicity
According to the HERA document on fatty acid salts (2002) “the available data for fatty acids provide a clear picture of low acute toxicity for this class of chemicals. All oral LD50values were greater than 2,000 mg/kg, with little mortality being observed even at the highest doses tested in the studies (IUCLID, 2000c, 2000e, 2000f, 2000g; Clayton & Clayton, 1982; CIR, 1987)” (HERA, 2002).
Additionally, based on animal data reported in the HERA document on fatty acid salts (2002), fatty acids with chain lengths of C18 to C22 showed no toxicity after oral administration to rats. The LD50was set above 5000 mg/kg bw. (HERA, 2002).
“In an OECD TG 401 study, a group of five rats/sex was administered docosanoic acid (C22) at a dose of 2000 mg/kg bw. There were no clinical signs, deaths, or findings at necropsy. The LD50was > 2000 mg/kg bw.”(OECD SIDS, 2014).
Further on, no acute oral toxicity could be observed in animal experiments with fatty acids with similar chain lengths, such as stearic acid (C18) or oleic acid (C18:1).
“International-BioResearch (1974, as referred to by CIR, 1987) determined the acute oral toxicity in groups of five male albino rats. Animals were administered by gavage lauric-, myristic-, palmitic- or stearic acid with increasing doses of up to 10,000 mg/kg bw and oleic acid up to 20,000 mg/kg bw. It was observed that for all these fatty acids the LD50value was above the maximum level tested. No mortality was observed in five albino rats gavaged with 5 g/kg bw oleic acid (commercially supplied); clinical signs were not reported during the 7-day post-exposure period (CTFA, 1978, as referred to in CIR, 1987)” (EFSA ANS Panel, 2017).
“In an OECD TG 401 study, a group of five rats/sex was administered octadecanoic acid (as a 50% suspension in DMSO) at a dose of 5000 mg/kg bw. There was one death. Animals exhibited transient piloerection, excessive salivation, and diminished activity. At necropsy, the male animal that died exhibited a stomach full of test substance; surviving animals showed remnants of test substance in the stomach with swelling of the mucous membrane. The LD50 was > 5000 mg/kg bw” (OECD SIDS, 2014).
Justification for classification or non-classification
The calculated oral LD50 for zinc didocosanoate is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE).
Zinc didocosanoate is not classified for acute inhalative toxicity because of lacking data.
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