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Endpoint summary

Description of key information

In a GLP compliant acute oral toxicity study in rats according to OECD guideline 423, the LD50 cut off was ≥ 5000 mg/kg bw.

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

Study period:

2021-05-11 to 2021-07-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

other: “Regulation on Test Methods for Chemical Substances” Notification No. 2020-46, National Institute of Environmental Research, Republic of Korea

Version / remarks:

2020-11-03

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

Adopted 2001-12-17

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Crl:CD(SD), SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 185.3 – 201.6 g
- Fasting period before study: 16 hours
- Housing: One animal per cage in stainless wire mesh cages, 260 x 350 x 210 mm
- Diet: Ad libitum (except for 4 hours after dosing)
- Water: Ad libitum
- Acclimation period: 7 days
- Microbiological status: SPF

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 – 23.0
- Humidity (%): 57.1 – 63.5
- Air changes (per hr): 10 − 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From day 1 to day 15

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle: 5 mL/kg bw
- Batch No: MKCM3364

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose level for this study was selected at 2000 mg/kg bw because the toxicity of the test substance was expected to be low by referring to the toxicity of similar substances.

Doses:

2000 mg/kg bw (2x3 animals)

No. of animals per sex per dose:

6 females at 2000 mg/kg bw (3 animals for step 1 and 3 animals for step 2)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs at 30 minutes and at 1, 2, 4 and 6 hours after dosing and once daily thereafter for 14 days. The body weight was recorded once on the day of dosing (prior to dosing), and on days 2, 4, 8 and 15.
- Necropsy of survivors performed: Yes
- Clinical signs including body weight: Clinical signs were recorded according to their type, severity, time of onset and recovery.
- Other examinations performed: Complete gross postmortem examinations. Since no gross findings were observed at necropsy, histopathological examination was not performed.

Statistics:

Statistical analysis was not performed. Mean scores and values were determined.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There were no deaths of animals at 2000 mg/kg bw throughout the study.

Clinical signs:

other: No abnormalities of clinical signs were observed in any animal at 2000 mg/kg bw throughout the study.

Gross pathology:

No abnormal gross findings were observed in any animal at 2000 mg/kg bw.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance was classified as ‘Category 5 or Unclassified’ according to the GHS classification, and the median lethal dose derived was: LD50 cut off ≥ 5000 mg/kg bw.

Executive summary:

This GLP compliant study according to OECD guideline 423 was conducted to assess the potential toxicity and to classify the test substance under the category of GHS classification following a single oral administration to 8-week-old female Sprague-Dawley rats. Two groups of three females each were utilized as follows:

Groups 1 and 2 (Steps 1 and 2): 2000 mg/kg bw of the test substance

Steps 1 − 2: A dose of 2000 mg/kg bw was administered and then, no mortality was observed (Step 1). A second dose of 2000 mg/kg bw was administered. Again, no mortality was observed (Step 2). The administration was finished at that point.

 

All animals were monitored for clinical signs and body weight changes during the 14-day observation period after dosing. They were subjected to a gross necropsy after euthanasia at the end of the observation period. There were no deaths of animals at 2000 mg/kg bw. No test substance-related effect was observed in clinical signs, body weight data or necropsy findings in the animals at 2000 mg/kg bw. Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance was classified as ‘Category 5 or Unclassified’ according to the GHS classification, and the median lethal dose derived was: LD50 cut off ≥ 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

> 2 000 mg/kg bw

Quality of whole database:

reliable without restrictions

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity, rats, RL1

A GLP compliant study according to OECD guideline 423 was conducted to assess the potential toxicity and to classify the test substance under the category of GHS classification following a single oral administration to 8-week-old female Sprague-Dawley rats. Two groups of three females each were utilized as follows:

Groups 1 and 2 (Steps 1 and 2): 2000 mg/kg bw of the test substance

Steps 1 − 2: A dose of 2000 mg/kg bw was administered and then, no mortality was observed (Step 1). A second dose of 2000 mg/kg bw was administered. Again, no mortality was observed (Step 2). The administration was finished at that point.

 

All animals were monitored for clinical signs and body weight changes during the 14-day observation period after dosing. They were subjected to a gross necropsy after euthanasia at the end of the observation period. There were no deaths of animals at 2000 mg/kg bw. No test substance-related effect was observed in clinical signs, body weight data or necropsy findings in the animals at 2000 mg/kg bw. Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance was classified as ‘Category 5 or Unclassified’ according to the GHS classification, and the median lethal dose derived was: LD50 cut off ≥ 5000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data, the test item does not require classification for acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for seventeenth time in Regulation (EU) No 2021/849.