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EC number: 267-012-8 | CAS number: 67762-34-9 This substance is identified by SDA Substance Name: C8-C18 and C18 unsaturated alkyl carboxylic acid zinc salt and SDA Reporting Number: 01-006-09.
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Zinc dioctanoate
- EC Number:
- 209-156-6
- EC Name:
- Zinc dioctanoate
- Cas Number:
- 557-09-5
- Molecular formula:
- C16H30O4Zn
- IUPAC Name:
- zinc(II) octanoate
- Reference substance name:
- Zinc decanoate
- EC Number:
- 235-909-3
- EC Name:
- Zinc decanoate
- Molecular formula:
- C10H20O2.1/2Zn
- IUPAC Name:
- zinc(II) decanoate
- Reference substance name:
- Zinc dilaurate
- EC Number:
- 219-518-5
- EC Name:
- Zinc dilaurate
- Cas Number:
- 2452-01-9
- Molecular formula:
- C12H24O2.1/2Zn
- IUPAC Name:
- zinc(II) dodecanoate
- Reference substance name:
- Zinc dimyristate
- EC Number:
- 240-369-7
- EC Name:
- Zinc dimyristate
- Cas Number:
- 16260-27-8
- Molecular formula:
- C28H54O4Zn
- IUPAC Name:
- zinc(II) tetradecanoate
- Reference substance name:
- Zinc dipalmitate
- EC Number:
- 225-652-5
- EC Name:
- Zinc dipalmitate
- Cas Number:
- 4991-47-3
- Molecular formula:
- C16H32O2.1/2Zn
- IUPAC Name:
- zinc(II) hexadecanoate
- Reference substance name:
- Zinc distearate
- EC Number:
- 209-151-9
- EC Name:
- Zinc distearate
- Cas Number:
- 557-05-1
- Molecular formula:
- C18H36O2.1/2Zn
- IUPAC Name:
- zinc(II) octadecanoate
- Reference substance name:
- Zinc dioleate
- EC Number:
- 209-154-5
- EC Name:
- Zinc dioleate
- Cas Number:
- 557-07-3
- Molecular formula:
- C18H34O2.1/2Zn
- IUPAC Name:
- zinc(II) 9-octadecenoate
- Reference substance name:
- Zinc dilinoleate
- EC Number:
- 235-870-2
- EC Name:
- Zinc dilinoleate
- Cas Number:
- 13014-44-3
- Molecular formula:
- C36H62O4Zn
- IUPAC Name:
- zinc(II) 9,12-octadecdienoate
- Test material form:
- solid: bulk
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on species / strain selection:
- 2.5.2. Reason for test system selection
The ICR mice are widely used in In vivo micronucleus study, and a large amount of historical data have been accumulated, facilitating the interpretation and evaluation of the test results easy.
2.5.3. Quarantine and acclimation
At receipt, all animals were recorded clinical signs and weight. After receipt, clinical signs were to be observed once a day during the acclimation period of quarantine 3 days and acclimation 4 days under the environment of CentralBio's animal room 20. At the end of the acclimation, measured weight and checked clinical signs and weight changes. And then, Only healthy individuals were used in the study.
2.5.4. Animal and cage identification
Individually identification of animals was carried out by marking each individual number on tail using an oil-based red pen during the acclimation period and blue pen during test period. Cages were identified by attaching an individual identification card.
2.5.5. Group separation
After acclimation, healthy animals were grouped using a randomization method based on body weight. At the time of group separation, uniformity was checked based on average body weight and standard deviation.
2.5.6. Remnant animal
The remnant animals were euthanized using CO2 gas on the day of necropsy. - Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species and strain : Mouse SPF, Hsd:ICR(CD-1®)
Breeder/Supplier : KOATECH Co., Ltd. (181-21 Jeonwi-ro, Jinwei-myeon, Pyeongtaek-si, Gyeonggi-do, Republic of Korea, 17711)
Step Age (Week) Sex Number of animals Range of body weight
Animals at acquisition
Dose range finding test I 7 Male 17 28.1~33.4 g
7 Female 17 23.0~27.7 g
Dose range finding test II 7 Male 17 29.9~33.5 g
7 Female 17 24.2~26.3 g
Main test 7 Male 33 28.6~32.9 g
At administration
Dose range finding test I 8 Male 15 1st,2nd administration (day1): 28.5~33.1 g
3nd,4nd administration (day2): 28.9~34.4 g
8 Female 15 1st,2nd administration (day1): 23.0~28.8 g
3nd,4nd administration (day2): 23.1~28.8 g
Dose range finding test II 8 Male 15 1st,2nd administration (day1): 33.2~35.6 g
3nd,4nd administration (day2): 30.7~36.2 g
8 Female 15 1st,2nd administration (day1): 24.3~28.3 g
3nd,4nd administration (day2): 24.2~28.3 g
Main test 8 Male 30 1st,2nd administration (day1): 31.7~35.1 g
3nd,4nd administration (day2): 28.8~35.2 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Dimethyl sulfoxide (DMSO)
- Frequency of treatment:
- The negative control substance and test substance were administrated twice divided doses/day at an interval of 2-hour, and administrated two days at an interval of 24-hour, and positive control substance was administrated intraperitoneally once on the day of the second administration of the test substance.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
Examinations
- Tissues and cell types examined:
- Bone marrow cells were collected within 24 hours after the second administration of the test substance.
Both ends of the femur were cut with scissors and extracted, and bone marrow cells were harvested by perfusion with fetal bovine serum(FBS). The harvested bone marrow cells were centrifuged at 1,000 rpm for 5 minutes. After removing the supernatant, the bone marrow cells were spread on a slide glass and dried sufficiently at room temperature. Two specimens were prepared for each animal. After drying, specimens were fixed for about 8 minutes with methanol. - Evaluation criteria:
- If the test substance meets the following criteria, it was judged as positive.
- When there is a statistically significant increase in the frequency of micronucleated polychromatic erythrocytes in one or more test substance group compared to the negative control
group.
- When this increase is dose-dependent in the frequency of micronucleated polychromatic erythrocytes.
- When these results are outside the range of the historical negative control data.
- If the micronucleus test result does not meet all criteria, it is judged as negative. - Statistics:
- Statistical processing was performed using the SPSS program for the frequency of micronucleated polychromatic erythrocytes, the frequency of polychromatic erythrocytes among total red blood cells, and changes in body weight. According to the result of statistical processing. It was determined that there is statistical significance when p<0.05. ANOVA(One-way analysis of variation) was performed to compare the means between groups, Dunnett test was performed if equivariability was satisfied through Levene’s test, and Dunnett's T3 test was performed if eqsssuivariability was not satisfied.
Linear regression confirmed the significance of dose-dependent of frequency of micronucleated polychromatic erythrocytes, and the frequency of polychromatic erythrocytes among total red blood cells.
Student t-test was performed for frequency of polychromatic erythrocytes among total red blood cells and frequency of micronucleated polychromatic erythrocytes in the negative and positive control groups to confirm their statistical significance.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Additional information on results:
- 4.3.1. Clinical signs
In all test substance groups, no clinical signs and death were observed following administration of the test substance.
4.3.2. Body weight
No significant body weight change was observed in all dose groups compared with the negative control group.
4.3.3. Frequency of polychromatic erythrocyte in total erythrocyte
There were no statistically significant differences in the frequency ratio of polychromatic erythrocytes in all test substance groups compared to the negative control group.
The frequency ratio of polychromatic erythrocytes in the positive control group was significantly decreased compared to the negative control group(p<0.05).
4.3.4. Frequency of micronucleus
The frequencies of micronucleated polychromatic erythrocytes observed in 4,000 polychromatic erythrocytes per group were 0.08±0.03 % in the negative control group, 0.09±0.05 % in the 500 mg/kg B.W. administration group, 0.08±0.04 % in the 1,000 mg/kg B.W. administration group, 0.08±0.04 % in the 2,000 mg/kg B.W. administration group, and 1.96±0.35 % in the positive control group.
The frequency of micronucleated polychromatic erythrocytes in polychromatic erythrocytes was no statistically significant increase in all test substance groups compared to the negative control group, and no dose-dependent increase was observed.
Applicant's summary and conclusion
- Conclusions:
- All validity criteria of this test were fulfilled.
As a result of counting micronucleated polychromatic erythrocytes for 4,000 polychromatic erythrocytes per group, there was no statistically significant increase in all test substance groups compared to the negative control group, and dose-dependent no increase was observed. Also, the frequency of polychromatic erythrocytes with micronucleus was included in the historical negative control data.
In conclusion, the test substance, Fatty acids, C8-18 and C18-unsatd., zinc salts do not induce micronucleus in polychromatic erythrocytes under the present test conditions.
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