1,2,3-tris(2,3-epoxypropoxy)propane

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:

1,2,3-tris(2,3-epoxypropoxy)propane

EC Number:

236-211-1

EC Name:

1,2,3-tris(2,3-epoxypropoxy)propane

Cas Number:

13236-02-7

Molecular formula:

C12H20O6

IUPAC Name:

1,2,3-tris(2,3-epoxypropoxy)propane

Constituent 2

Reference substance name:

N/A

Cas Number:

178667-42-0

Molecular formula:

C12H24O8

IUPAC Name:

N/A

Test material form:

liquid

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:

occlusive

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 h

Doses:

Range-finding study: 200, 1,000, 2,000 (mg/kg b.w.)
Main study: 2,000 (mg/kg b.w.)

No. of animals per sex per dose:

Range-finding study: 1, 1, 1
Main study: 2

Control animals:

not specified

Statistics:

Statistical analysis was not performed.

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: Crust formation, Purpura, Erythema

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.

Other findings:

As a result of observing the site of administration at each step, very slight erythema(score: 1) was
observed at 0 to 72 hours after removing the gauze in the range-finding study(3 step).
In the main study(step 1), very slight erythema(score: 1) was observed in 1 female(#4) at 0 to 72 hours and 1 female(#5) at 0 hour. Slight erythema(score: 2) was observed in 1 female(#5) at 24 to 72 hours.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

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, KF EPIOL-PE311(GPGE), 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.

Crust formation observed in the range-finding study(step 3) and main study(step 1), purpura observed in the range-finding study(step 3), and erythema observed in the main study(step 1) 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.

Partial crust formation observed in the range-finding study(step 3) and main study(step 1) are determined by the influence of the test substance.
As a result, the test substance, KF EPIOL-PE311(GPGE) is confirmed as GHS Category 5/Unclassified in this study.