3-(1-ethoxyethyl)-5-methyl-oxazolidin-2-one

Endpoint summary

Description of key information

LD50 (oral, rat): > 2000 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

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: young adult animals (approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: 16 hours before administration
- Housing: single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at leasst 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 30 - 70 %
- Humidity (%): 22°C +/- 3°C
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in both 2000 mg/kg bw test groups.

Clinical signs:

2000 mg/kg bw(first test group): two animals showed poor general state from hour 0 until hour 5. Impaired general state was seen in these animals from study day 1 until study day 6, while in the third animal this finding was noticed from hour 0 until hour 5 after administration. Dyspnoea was noted in all animals from hour 0 until hour 5 and persisted in one animal until study day 1. Piloerection was recorded in one animal from hour 0 until hour 5. The same finding was observed in the two other animals from study day 1 until study day 6 after administration. In one animal abdominal position and tremor was seen from hour 0 until hour 5, while atonia was noticed from hour 1 until hour 5 and lacrimation from hour 4 until hour 5. Reduced defecation was noted from day 1 until day 2 in this animal. In another animal lateral position was observed from hour 0 until hour 5, while clonic convulsions were seen from hour 1 until hour 5 in this animal. Furthermore, salivation was recorded from hour 0 until hour 1 and lacrimation from hour 4 until hour 5, while exsiccosis, reduced defecation and chromodacryorrhea was noticed in this animal on study day 1; reduced defecation persisted until day 2. Additional findings in the third animal revealed salivation from hour 0 until hour 1, while cowering position was seen from hour 1 until hour 5 in this animal.
2000 mg/kg bw (second test group): poor general state was seen in all animals from hour 0 until hour 1, 2 or 3, followed by impaired general state from hour 2, 3 or 4 until hour 5 after administration. In all animals dyspnoea and piloerection was observed from hour 0 until hour 2 or 5. Abdominal position was noticed in two animals from hour 0 until hour 1 or 2. Cowering position was seen in these animals from hour 2 until hour 3 or from hour 3 until hour 5. In the third animal this finding was noted from hour 0 until hour 5. In addition, ataxia and tremor was observed in this animal from hour 0 until hour 2 after administration.

Body weight:

The body weight of one animal in each test group increased within the normal range throughout the study period. The body weights of the two other animals in both test group increased in a normal range during the first observation week but these animals only slightly gained weight during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth.

Gross pathology:

There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females).

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose of 3-(1-Ethoxyethyl)-5-methyloxazolidin-2-on after oral administration was found to be greater than 2000 mg/kg bw in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

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

In an acute oral toxicity study performed according to the Acute Toxic Class Method, 2000 mg/kg of the undiluted test item 3-(1-Ethoxyethyl)-5-methyloxazolidin-2-on were administered by gavage to two test groups of three fasted Wistar rats each (6 females). The following test substance-related clinical observations were recorded, clinical signs occurred within six days after administration.

In the first test group (2000 mg/kg) no mortality occurred, impaired general state in all animals, poor general state in two animals, piloerection in all animals, dyspnoea in all animals, abdominal position in one animal, lateral position in one animal, cowering position in one animal, lacrimation in two animals, salivation in two animals, chromodacryorrhea in one animal, atonia in one animal, tremor in one animal, clonic convulsions in one animal, exsiccosis in one animal and reduced defecation in two animals. In the second test group (2000 mg/kg) no mortality occurred, impaired general state in all animals, poor general state in all animals, piloerection in all animals, dyspnoea in all animals, abdominal position in two animals, cowering position in all animals, ataxia in one animal and tremor in one animal. The body weight of one animal in each test group increased within the normal range throughout the study period. The body weights of the two other animals in both test group increased in a normal range during the first observation week but these animals only slightly gained weight during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females). Under the conditions of this study the median lethal dose of 3-(1-Ethoxyethyl)-5-methyloxazolidin-2-on after oral administration was found to be greater than 2000 mg/kg bw in rats.

Justification for classification or non-classification

Based on the results, the test item is no subject to classification and labelling according to Regulation (EC) No 1272/2008 (CLP).