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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- 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 442B (Skin sensitisation: Local Lymph Node Assay: BrdU-ELISA or –FCM)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Species and strain:CBA/JCrHsd mice
Microbiological grade:Specific Pathogen Free(SPF)
Sex:Female
Breeder/Supplier:KOATECH_Korea(181-21 Jinwi-ro, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, Republic of Korea, 17711)
Step Age(Week) Sex Number of animals
Animals at acquisition (Pre-screen test) 8 Female 6
At administration (Pre-screen test) 9 Female 5
Animals at acquisition (Main test) 8 Female 25
At administration (Main test) 9 Female 24
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- The concentrations of 10.0 %(w/v), 5.0 %(w/v) and 2.5 %(w/v) were selected in the main test based on the result of the pre-screen test. In addition, additional negative and positive controls were set up to administer Acetone:Olive oil (4:1, v/v), MEK and Eugenol 25.0 %(w/v) respectively to compare with the test substance treatment groups.
- No. of animals per dose:
- Main test: 4
- Details on study design:
- Test substance Group Dose Sex Number of animals Animal number
Acetone:Olive Oil 4:1(v/v) G1 – Female 4 1~4
MEK G2 – Female 4 5~8
Eugenol G3 25.0 %(w/v) Female 4 9~12
Fatty acids, C8-18 and C18-unsatd., zinc salts
G4 2.5 %(w/v) Female 4 13~16
G5 5.0 %(w/v) Female 4 17~20
G6 10.0 %(w/v) Female 4 21~24
3.2.3. Experimental schedule
3.2.3.1. Treatment of substance: Day 1~Day 3
The test substance, vehicle, and positive control were treated over the entire dorsal surface of the ear once a day up to Day 3 using a micropipette at 25 μL/ear to each corresponding group.
3.2.3.2. No treatment: Day 4
No Treatment
3.2.3.3. BrdU solution injection: Day 5
Intraperitoneal(IP) injection 0.5 mL(5 mg/mouse) of BrdU at a concentration of 10 mg/mL solution approximately 24 hours prior to the extraction of the auricular lymph node.
3.2.3.4. Auricular lymph node extraction: Day 6
Approximately 24 hours after BrdU injection, all animals were euthanized with CO2 gas. The auricular lymph nodes were excised from each mouse and gently disassembled using 70 micro-mesh(SPL, Cell Strainer) and distributed with PBS(1×) for a total volume of 15 mL.
3.2.3.5. Cellular proliferation measurement: Day 6
BrdU intensity was measured by ELISA using a commercial kit. Briefly, 100 μL of the lymph node cells(LNC) suspension was added to the wells of a flat-bottom microplate in triplicate. After fixation and denaturation of the LNC suspension, anti-BrdU antibody was added to each well and allowed to react. Subsequently, anti-BrdU antibody was removed by washing and then the substrate solution was added and allowed to produce chromogen. Absorbance at 370 nm(Emission wavelength, em) with a reference wavelength of 492 nm(Reference wavelength, ref) was measured. - Positive control substance(s):
- eugenol (CAS No 97-53-0)
- Statistics:
- The SPSS Statistical Program(IBM, Ver. 25) was used to conduct statistical analysis of the body weights and the ear thickness. After testing the normality of the variance(Anderson Darling or other appropriate method), statistics was processed as One-way ANOVA test. Then, homogeneity of variances was verified with Levene’s test. In case of homogeneity, the Dunnett test was conducted as a post-hoc test and in case of heteroscedasticity, the Dunnett T3 was conducted as a post-hoc test to confirm the significance with the control group. P-values<0.05 was considered statistically significant.
Results and discussion
- Positive control results:
- The Stimulation index(SI) of the positive control group, Eugenol 25.0 %(w/v), was calculated as 2.414 and the result was confirmed as the SI of the positive control met the reference of "SI≥1.6".
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 1.702
- Test group / Remarks:
- 2.5 %(w/v)
- Key result
- Parameter:
- SI
- Value:
- ca. 1.926
- Test group / Remarks:
- 5.0 %(w/v)
- Key result
- Parameter:
- SI
- Value:
- ca. 2.545
- Test group / Remarks:
- 10.0 %(w/v)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- This study was conducted to assess the skin sensitization potential of the test substance, Fatty acids, C8-18 and C18-unsatd., zinc salts, by measuring the proliferation of lymphocytes in the auricular lymph nodes through 5-Bromo-2'-Deoxyuridine content analysis following applications to female CBA/J mice.
The results are as follows.
The Stimulation index(SI) of the positive control group, Eugenol 25.0 %(w/v), was calculated as 2.414 and the result was confirmed as the SI of the positive control met the reference of "SI≥1.6".
The SI index of the test substance for 2.5 %(w/v), 5.0 %(w/v) and 10.0 %(w/v) treated group were determined as 1.702, 1.926 and 2.545 respectively, and all test substance groups were confirmed to be positive as the results.
In conclusion, the test substance, Fatty acids, C8-18 and C18-unsatd., zinc salts, was considered to cause skin sensitization at 2.5 %(w/v), 5.0 %(w/v) and 10.0 %(w/v).
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