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

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw