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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 May 2017 to 7 June 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Adopted 17th December 2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
other: "Regulation on Test Methods for Chemical Substances" Notification No. 2017-4, National Institute of Environmental Research, Republic of Korea (Mar. 14, 2017)
Deviations:
not specified
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ORIENTBIO INC., Republic of Korea
- Age at study initiation: 8 weeks
- Weight at study initiation: 183.0-185.1 g
- Fasting period before study: yes, animals were fasted overnight, approximately 16 hours prior to dosing
- Housing: one animal/ cage
- Diet (e.g. ad libitum): Pelleted rodent chow, ad libitum
- Water (e.g. ad libitum): Public tap water in Cheongju-si was filtered and irradiated by ultraviolet light and provided ad libitum.
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1−23.2°C (Measured value)
- Humidity (%): 43.7 - 53.9 % (Measured value)
- Air changes (per hr): 10−15 clean, fresh, filtered air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle, 150 - 300 Lux

IN-LIFE DATES: From: To: 16 May - 2 June 2017

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 400 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg body weight

- Rationale for the selection of the starting dose: The starting dose of 2,000 mg/kg was selected due to the low expected toxicity of the test item.
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 groups of 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality, general condition and clinical signs at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days (Day 1−Day 14). The body weight was recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: complete gross postmortem examinations
Statistics:
Statistical analysis was not performed. Mean scores and values were determined.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities observed at 2000 mg/kg.
Clinical signs:
Abnormal gait was observed in 2−4 animals at 2000 mg/kg at 2−6 hours after dosing, and mucous stool was observed in all animals on Day 1. These signs disappeared on Day 2.
Body weight:
Normal body weight gain was observed in all animals at 2000 mg/kg throughout the study.
Gross pathology:
No grossly visible findings were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The test item was classified as Category 5 or Unclassified according to the GHS classification and the median lethal dose derived was: LD50 cut off ≥ 5,000 mg/kg b.w.
Executive summary:

The toxicity of test item following a single oral dose administration to female Sprague-Dawley rats was tested according to OECD 423 and EU B.1 tris guidelines.

All animals were monitored for clinical signs and body weight changes during the 14-day observation period after administration and a gross necropsy was performed at the end of the observation period.

There were no deaths of animals at 2000 mg/kg. Abnormal gait was observed in animals at 2000 mg/kg on the day of dosing and mucous stool was observed on Day 1. And they disappeared on Day 2. No test substance-related effects were observed in body weight data or necropsy findings in any animal at 2000 mg/kg. The test item was classified as Category 5 or Unclassified according to the GHS classification and the median lethal dose derived was: LD50 cut off ≥ 5,000 mg/kg b.w.