2,2'-[ethylenebis(oxymethylene)]bisoxirane

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Adopted: 17 December 2001

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[ethylenebis(oxymethylene)]bisoxirane

EC Number:

218-746-2

EC Name:

2,2'-[ethylenebis(oxymethylene)]bisoxirane

Cas Number:

2224-15-9

Molecular formula:

C8H14O4

IUPAC Name:

2,2'-[ethylenebis(oxymethylene)]bisoxirane

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ORIENTBIO INC., Republic of Korea
- Age at study initiation: 8−9 weeks old
- Weight at study initiation: 180.8−213.8 g
- Fasting period before study: Animals were fasted overnight, approximately 16 hours prior to dosing. Feed was provided approximately 4 hours post dosing.
- Housing: one animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: all animals were quarantined for 3 days, moved from the quarantine room to the animal room and acclimated for 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): measurement value: 20.6−24.2 (permissible range: 19.0-25.0)
- Humidity (%): measurement value: 39.9−54.2 (permissible range: 30.0-70.0)
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

water for injection

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): individual doses were calculated based on the animal’s body weight recorded just prior to dosing at a dose volume of 10 mL/kg body weight.
- Lot/batch no.: DBA6008 (JW Pharmaceutical Co., Ltd., Republic of Korea)

CLASS METHOD
- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance, 2,000 mg/kg was selected as the starting dose for this study based on the information supplied by the sponsor.

Doses:

300 and 2000 mg/kg

No. of animals per sex per dose:

300 mg/kg: 6 animals
2000 mg/kg: 3 animals

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 (type, severity, time of onset and recovery) 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, on Days 1, 3, 7 and on the day of necropsy (Day 14).
- Necropsy of survivors performed: yes
- Other examinations performed: Since no gross findings were observed at necropsy, histopathological examinations were not performed.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

300 mg/kg: 0/6 deaths
2000 mg/kg: 3/3 deaths

Clinical signs:

other: In all three dead animals at 2,000 mg/kg, abnormal gait and/or lacrimation were observed at 2 and 4 hours after dosing.

Gross pathology:

No grossly visible findings were observed in any animal at 300 and 2,000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria