2-(1-ethylpentyl)-1,3-dioxolane

Endpoint summary

Description of key information

Acute oral toxicity: OECD TG 401: 7100 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:

The study was conducted in May 1978.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Reliability 2 is assigned because although the study was conducted similar to the current OECD TG 401, the guideline is not referenced and there is no documentation on experimental conditions. The study is also non-GLP. Except for that, the total number of tested animals was 4 instead of 5 and they were not all of the same sex.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

The total number of tested animals was 4 instead of 5 and they were not all of the same sex.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Remarks:

albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats were in the weight range 250-320 g (males) and 135-188 g (females) at the initiation of the study. Rats were housed in groups of two in screen-bottomed stainless steel cages, in a well-ventilated room, maintained at 23-25°C.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Syvertal was administered at the appropriate doses to each rat by oral gavage. Before dosing, the rats were fasted overnight.

Doses:

Five doses were used in the study: 1250, 2500, 5000, 10000 and 20000 mg/kg bw.

No. of animals per sex per dose:

4 rats per dose, 2 per sex per dose: 2 males and 2 females.

Control animals:

no

Details on study design:

- After treatment the rats received stock diet and tap water ad libitum
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

7 100 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred at the doses of 1250, 2500 and 5000 mg/kg bw. All 4 animals died after treatment with the doses 10000 and 20000 mg/kg bw. Deaths occurred between 2 hours and 3 days after dosing.

Clinical signs:

Rats receiving the doses of 1250 and 2500 mg/kg bw did not show any reaction to the treatment and the rats looked quite healthy during the whole observation period. Rats receiving the dose of 5000 mg/kg bw showed sluggishness within a few hours after dosing. One male in the 5000 mg/kg bw group and all rats dosed 10000 and 20000 mg/kg bw lost consciousness. The survivors recovered and looked quite healthy again at the end of the observation period.

Gross pathology:

Terminal necropsy of the survivors revealed no treatment-related gross alterations.

Other findings:

No other findings were noted.

Interpretation of results:

other: Not classified.

Remarks:

According to EU CLP 1272/2008 and its amendments.

Conclusions:

Acute oral toxicity was performed similar to the guideline OECD TG 401. The acute oral LD50 for the substance in male and female rats was determined to be 7100 mg/kg bw.

Executive summary:

Acute oral toxicity was performed similar to the guideline OECD TG 401. Four rats (males and females) per dose were administered the substance at doses: 1250, 2500, 5000, 10000 and 20000 mg/kg bw. No deaths occurred at the doses of 1250, 2500 and 5000 mg/kg bw. All 4 animals died after treatment with the doses 10000 and 20000 mg/kg bw. The clinical signs observed during the study included: sluggishness, losing consciousness and death.Gross autopsy of the survivors did not demonstrate any treatment-related gross alterations. The acute oral LD50 for the substance in male and female rats was determined to be 7100 mg/kg bw, therefore the substance is not acute toxic.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity was performed similar to the guideline OECD TG 401. Four rats (males and females) per dose were administered the substance at doses: 1250, 2500, 5000, 10000 and 20000 mg/kg bw. No deaths occurred at the doses of 1250, 2500 and 5000 mg/kg bw. All 4 animals died after treatment with the doses 10000 and 20000 mg/kg bw. The clinical signs observed during the study included: sluggishness, losing consciousness and death.Gross autopsy of the survivors did not demonstrate any treatment-related gross alterations. The acute oral LD50 for the substance in male and female rats was determined to be 7100 mg/kg bw, therefore the substance is not acute toxic.

Justification for classification or non-classification

According to the criteria outlined in EU CLP 1272/2008/EC (and its amendments), the substance does not have to be classified as acute toxic by the oral route.