Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain : NSam: Sprague-Dawley Rat
Microbiological grade : Specific Pathogen Free(SPF)
Sex : Female(nulliparous and non-pregnant)
Breeder : Samtako Bio Korea
(105, Seorang-ro, Osan-si, Gyeonggi-do, Republic of Korea)
Supplier : Young Bio Co., Ltd.
(388, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do,
Republic of Korea)
Step Age(week old) Sex Number of animals
Animals at acquisition 8 Female 13
1st step administration 9 Female 3
2nd step administration 9 Female 3
3rd step administration 10 Female 3
4th step administration 10 Female 3
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- The test substance was administered in single dosing at a dose level of 300 mg/kg b.w.(1st and 2nd step) and 2,000 mg/kg b.w.(3rd and 4th step).
- No. of animals per sex per dose:
- 3
- Control animals:
- not specified
- Details on study design:
- 3.1.2. Dose level
1st step The starting dose level was selected as 300 mg/kg body weight (b.w.) due to a lack of
toxicity information of the test substance.
2nd step After the 1st step dosing(before the 2nd step dosing), no dead animals were observed.
Thus, the 2nd step dose level was selected as 300 mg/kg b.w..
3rd step After the 2nd step dosing(before the 3rd step dosing), no dead animals were observed.
Thus, the 3rd step dose level was selected as 2,000 mg/kg b.w..
4th step After the 3rd step dosing(before the 4th step dosing), no dead animals were observed.
Thus, the 4th step dose level was selected as 2,000 mg/kg b.w..
3.2. Administration of Test Substance
3.2.1. Justification for route of administration
The oral route was selected to investigate the oral toxicity of test substance.
3.2.2. Dose frequency
Single administration
3.2.3. Dosage
The dose volume was set as 5 mL/kg b.w., and the dosage for each animal were calculated on the
basis of fasted body weight on the administration day.
3.2.4. Method
The animals were fasted for over-night(over 16 hours with water provided ad libitum) and orally
administered once by gavage using a feeding needle(gavage needle). Feed was provided
approximately 4 hours post-dosing.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in this study.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- No body weight changes related to the test substance administration were observed in all animals in the 300 mg/kg b.w.(1st and 2nd step) and 2,000 mg/kg b.w.(3rd and 4th step) groups.
- Gross pathology:
- No gross lesions related to the test substance administration were observed in all animals in the 300 mg/kg b.w.(1st and 2nd step) and 2,000 mg/kg b.w.(3rd and 4th step) groups.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This study was conducted to confirm the GHS category and LD50 cut-off value based on the acute toxicity of the test substance, Fatty acids, C8-18 and C18-unsatd., zinc salts, following a single oral administration to female Sprague-Dawley rats. The test substance was administered in a single dose at dose of 300 mg/kg b.w.(1st and 2nd step) and 2,000 mg/kg b.w.(3rd and 4th step). Three animals were used for each step. Mortality, clinical signs and body weights were observed for 14 days. Also, at the end of the 14-day observation period for each step, gross necropsy was performed.
No mortality was observed in this study.
No clinical signs were observed in the 300 mg/kg b.w.(1st and 2nd step) and 2,000 mg/kg b.w.(3rd and 4th step) groups.
No body weight changes related to the test substance administration were observed in all animals in the 300 mg/kg b.w.(1st and 2nd step) and 2,000 mg/kg b.w.(3rd and 4th step) groups.
No gross lesions related to the test substance administration were observed in all animals in the 300 mg/kg b.w.(1st and 2nd step) and 2,000 mg/kg b.w.(3rd and 4th step) groups.
As a result, the test substance, Fatty acids, C8-18 and C18-unsatd., zinc salts, was confirmed as GHS (Globally Harmonized System of Classification and Labelling of Chemicals) Category 5 and the oral LD50 cut-off was determined as greater than 2,000 mg/kg b.w. in this study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
