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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

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)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
other:
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
During the test period, the temperature and humidity of the animal room were recorded by measure data in every 1 hr with an automatic temperature and humidity meter in every 5 min intervals.
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The test substance was orally administered once.
Doses:
10 mL/kg Body weight
No. of animals per sex per dose:
1st step(300 mg/kg bw): 3/female
2nd step(300 mg/kg bw): 3/female
3rd step(2,000 mg/kg bw): 3/female
Control animals:
no
Details on study design:
1. Room No.: Rodent 4
2. Cage type and size: Stainless wire cage (420 W×270 L×180 H mm)
3. Animals per cage: 3 animal/cage (during the study)
4. Temperature: 21.0 ~ 23.5 ºC
5. Relative humidity: 45.5 ~ 57.7%
6. Air exchange: 10 ~ 15 / hr
7. Light cycle: 12 hour light / 12 hour dark
8. Illumination: 150 ~ 300 lux
9. Water: Public tap water was filtered and irradiated by ultraviolet light and with ad libitum bottle using automatic feed water system. The absence of contamination was confirmed with periodical analysis results report of manufacture.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals died in the test substance administration group at 2000 mg/kg body weight (3 rd step) respectively. No dead animals were observed in the remaining 300 mg/kg body weight (1 st step and 2 nd step) test substance administration group.
Clinical signs:
other: Prone position was observed for all animals 30 minutes after administration in 2000 mg / kg administration group (3 rd step). At 1 hour after administration, Prone position, Soiled perineal region and Soft stool were observed in all animals, one died, the
Gross pathology:
In necropsy finding of died animals, Soiled perineal region were observed in all died animals. There were no necropsy findings caused by administration of test substance in all survived animals.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance was classified into GHS (Globally Harmonized Classification System for Chemical Substances and Mixtures) Category 4 in this study.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
> 300 - < 2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

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:
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.
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw

Additional information

Justification for classification or non-classification