Registration Dossier
Registration Dossier
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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.
Toxicological information
Eye irritation
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Administrative data
- Endpoint:
- eye irritation: in vivo
- 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 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species and strain : Sam: New Zealand White Rabbit
Microbiological grade : Specific Pathogen Free(SPF)
Sex : Female
Breeder : SAMTAKO BIO KOREA (105, Seorang-ro, Osan-si, Gyeonggi-do,
Republic of Korea, 18100)
Supplier : Yeongbio (388, Dunchon-daero, Jungwon-gu, Seongnam-si,
Gyeonggi-do, Republic of Korea, 13391)
Step Age (week old) Sex Number of animals A range of body weight(g)
At receipt 10 Female 4 1716.2~1887.8
At application 11 Female 3 2073.3~2190.2
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g of test substance was applied per eye
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 3.2.2 Method
5 minutes prior to application, 1~2 drops of 0.5 % Alcaine Eye Drops (proparacaine hydrochloride,
Alcon_Korea) was applied to each eye for local anesthesia.
The test substance was administered to the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second to prevent loss of test substance. The left eye remained untreated and served as a control.
3.2.2.1 Initial test (in vivo eye irritation/corrosion test using one animal)
One animal was used in the initial test and no serious eye damage/irreversible effect was observed at 1 hour after the test substance application.
3.2.2.2 Confirmatory test (in vivo eye irritation test with additional two animals)
In the initial test conducted on one animal, no serious eye damage/irreversible effect was observed at the application site after 1 hour. Therefore, a confirmatory test was conducted with two additional animals with the same procedure.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This study was conducted to confirm the Globally Harmonized System of Classification and Labelling of Chemical (GHS) category through the calculation of Eye Irritation Scores based on the acute eye irritation and corrosivity of the test substance, Fatty acids, C8-18 and C18-unsatd., zinc salts, following a single application on the eyes of New Zealand White rabbits. Mortality, clinical signs and body weight changes, eye irritations and corrosivity were observed after the application.
Mortality and clinical signs related to the test substance were not observed in all animals.
Body weight changes related to the test substance were not observed in all animals.
Corrosion was not observed in all animals up to 72 hours after application of the test substance.
In the initial test and confirmatory tests, eye irritations of redness and swelling in conjunctiva were observed at 1(3 case), 24(3 case) and 48(1 case) hours after the application of the test substance. The effects listed above were fully reversible within 3 days of observation. The eye irritation scores of cornea, iris were calculated as “0.0” in all animals. The conjunctiva(redness) was calculated as “1.0”, “0.3” and “0.3”. The conjunctiva(swelling) was calculated as “1.0”, “0.3” and “0.3”.
Therefore, the test substance was considered to be non-irritants and the 21-day observation period required to establish reversibility was not applied.
The above results show that when applying the test substance, Fatty acids, C8-18 and C18-unsatd., zinc salts to under the conditions of this study, considered to be “Not classified” according to the GHS category.
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