Fatty acids, C8-18 and C18-unsatd., zinc salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

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

Constituent 2

Reference substance name:

Zinc decanoate

EC Number:

235-909-3

EC Name:

Zinc decanoate

Molecular formula:

C10H20O2.1/2Zn

IUPAC Name:

zinc(II) decanoate

Constituent 3

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

Constituent 4

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

Constituent 5

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

Constituent 6

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

Constituent 7

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

Constituent 8

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

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
At acquisition 7 Female 10
Range-finding study
G1(step 1) 8 Female 1
G2(step 2) 8 Female 1
G3(step 3) 9 Female 1
Main study
G4(step 1) 9 Female 2

Administration / exposure

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

3.2. Administration of Test Substance
3.2.1. Justification for route of administration
The dermal route was selected to investigate the dermal toxicity of test substance.
3.2.2. Dose frequency and duration
Single dermal administration of continuous exposure for 24 hours.
3.2.3. Administration
The dose volume was calculated on the basis of body weight on the administration day.
3.2.4. Method
The test substance was spread on the porous gauze and attached to the administration area.
Non-irritating tape(Tegarderm, 3M) and elastic bandages(Coban, 3M) were used to prevent the loss of test substance and to have the test substance in good contact with the skin continuously for 24 hours.
After the 24-hour exposure of the test substance, the gauze, non-irritating tape, and elastic bandages were removed and residual test substance was removed using sterilized distilled water.

Duration of exposure:

24 hours

Doses:

G1 (Range-finding study step 1)
The starting dose level was selected as 200 mg/kg body weight (b.w.) due to a lack of toxicity information of the test substance.

G2 (Range-finding study step 2)
As a result of observation after the step 1 administration(before administration of the step 2), no dead animal was observed. Thus, the dose level was selected as 1,000 mg/kg b.w..

G3 (Range-finding study step 3)
As a result of observation after the step 2 administration(before administration of the step 3), no dead animal was observed. Thus, the dose level was selected as 2,000 mg/kg b.w..

G4 (Main study step 1)
As a result of observation after the step 3 administration, no dead animals were observed in all does levels of range-finding study. Thus, the starting dose level of the main study was selected as 2,000 mg/kg b.w..

No. of animals per sex per dose:

range-rinding study: 1
main study: 2

Control animals:

not specified

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:

In all administration groups of the range-finding study and main study, body weight loss was observed on day 1 after the administration. However, body weight gains were noted on day 3, 7, and 14 measurements.

Gross pathology:

No gross lesions related to the test substance administration were observed in all animals of the rangefinding study and the main study.

Other findings:

As a result of observing the site of administration at each step, very slight erythema(score: 1) was observed at 0 hour and 24 hours, and slight erythema(score: 2) was observed at 48 hours and 72 hours after removing the test substance in the range-finding study(3 step).
In the main study(step 1), slight erythema(score: 2) was observed in 2 animals at 24 and 48 hours. 1 animal recovered at 72 hours, but slight erythema(score: 2) was observed in the other animal at 72 hours.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

This study was conducted to confirm the GHS(Globally Harmonized System of Classification and Labelling
of Chemicals) category based on the acute toxicity of the test substance, Fatty acids, C8-18 and C18-unsatd.,
zinc salts, following a single dermal administration to female Sprague-Dawley rats. In the range-finding
study, the dose levels were set as 200 mg/kg b.w(step 1), 1,000 mg/kg b.w.(step 2) and 2,000 mg/kg b.w.(step
3). In the main study, the dose level was set as 2,000 mg/kg b.w.(step 1).
The test substance was administered to one animal in each step in the range-finding study, and two animals
in the main study. Mortality, clinical signs and body weights were observed for 14 days and at the end of the
14-day observation period for each step, gross necropsy was performed.
No mortality was observed in this study.
Erythema and exfoliation observed in the range-finding study(3 step) and main study(1 step) are determined
by the influence of the test substance.
In all administration groups of the range-finding study and main study, body weight loss was observed on
day 1 after the administration. The body weight loss observed on day 1 in all administration groups are
considered to be a temporary phenomenon caused by continuously fixing with the elastic bandage for 24
hours during the administration procedure.
No gross lesions related to the test substance administration were observed in all animals of the range-finding
study and the main study.
As a result, the test substance, Fatty acids, C8-18 and C18-unsatd., zinc salts is confirmed as GHS Category
5/Unclassified in this study.