Ethyl pyruvate

Endpoint summary

Description of key information

Acute oral LD50 of ethyl pyruvate in a vehicle of corn oil is greater than 5000 mg/kg in male and female Sprague-Dawley rats.

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:

31 October 1989 - 21 November 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: This study was conducted in compliance with the Food and Drug Administration (FDA) Good Laboratory Practice (GLP) standards, as set forth in 21 CFR Part 58.

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Simonsen Laboratories (Gilroy, CA)
- Females (if applicable) nulliparous and non-pregnant: -Not specified
- Age at study initiation: 26 days of age on receipt.
- Weight at study initiation:Male rats weighing in at 106 and 118 g and five female rats weighing between 93 and 109 g
- Fasting period before study:
- Housing:Rats were housed five per cage in hanging polycarbonate cages containing hardwood-chip bedding (Sani-Chips®, P.J. Murphy Forest Products, Montville, NJ
- Diet (e.g. ad libitum): A commercial rodent diet (Purina Certified Rodent Chow, #5002) and UV-purified drinking water, available via an automatic watering system, were supplied ad libitum.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): oom temperature during the study was maintained at 75 ± 3°F
- Humidity (%): relative humidity of 24% to 49%
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): Not specified

IN-LIFE DATES: From: 31 October 1989 To: 21 November 1989

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

To determine a range of acute oral toxicity of ethyl pyruvate (with a limit of 5000 mg/kg), we treated groups of five male rats weighing between 106 and 118 g and five female rats weighing between 93 and 109 g with 1250, 2500, or 5000 mg/kg of ethyl pyruvate in a vehicle of corn oil.

Dose mixtures were administered in a single dose by oral gavage, using a calibrated syringe and ball-tipped intubation needle, at a volume of 1 ml per 100 g of body weight (10 ml/kg); dose volumes were based on body weights taken immediately before dosing. All rats were fasted overnight before treatment.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg dose volumes were based on body weights taken immediately before dosing.



CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

1250, 2500, or 5000 mg/kg of ethyl pyruvate in a vehicle of corn oil.
Dose mixtures were administered in a single dose by oral gavage.

No. of animals per sex per dose:

10 animals per dose.
5 females and 5 males.

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

No statistics provided

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred in any of the male or female rats treated with a single oral dose of ethyl pyruvate in a vehicle of corn oil at levels of 1250, 2500, or 5000 mg/kg

Clinical signs:

other: All male and female rats receiving 5000 mg/kg of the test substance were observed with tremors and gasping within 5 min of treatment. The tremors subsided within 10 min of treatment; all rats were hypoactive at that time and only two of the five female ra

Gross pathology:

No grossly observable abnormalities were apparent at the end of the 2-week observation period upon necropsy of male and female rats treated with 1250, 2500, or 5000 mg/kg methyl pyruvate.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on the results of this study, we conclude that the acute oral LD50 of ethyl pyruvate in a vehicle of corn oil is greater than 5000 mg/kg in male and female Sprague-Dawley rats.

Executive summary:

To determine the acute oral toxicity of ethyl pyruvate, SRI treated groups of young adult Sprague-Dawley rats containing five males and five females each with a single oral dose of ethyl pyruvate in a vehicle of corn oil at levels of 1250, 2500, or 5000 mg/kg. Daily observations for physiologic and behavioral responses and mortality were continued for 14 days after treatment. Body weights were taken shortly before administration of the test substance and weekly thereafter during the 2-week observation period. All rats were necropsied at the end of the 2-week study.

No deaths occurred in any of the male or female rats treated with a single oral dose of ethyl pyruvate in a vehicle of corn oil at levels of 1250, 2500, or 5000 mg/kg. All male and female rats receiving 5000 mg/kg of the test substance were observed with tremors and gasping within 5 min of treatment. The tremors subsided within 10 min of treatment; all rats were hypoactive at that time and only two of the five female rats continued to gasp. All 5000-mg/kg male and female rats appeared normal within 2 hr of treatment. No clinical signs of toxicity were observed in male and female rats following treatment with 1250 or 2500 mg/kg of the test substance.

Average weight gains of male and female rats treated with 5000 mg/kg ethyl pyruvate were only slightly lower than those of the 1250-mg/kg male and female rats. Average weight gains of male and female rats treated with 1250 and 2500 mg/kg ethyl pyruvate were comparable by sex. No grossly observable abnormalities were apparent in any of the male or female rats upon necropsy at the end of the 2-week study.

Based on the results of this study, we conclude that the acute oral LD50 of ethyl pyruvate in a vehicle of corn oil is greater than 5000 mg/kg in male and female Sprague-Dawley rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 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

Justification for classification or non-classification

According to the CLP criteria LD50 values greater than 2000mg are not classified as hazardous and the acute oral LD50 of ethyl pyruvate in a vehicle of corn oil is greater than 5000 mg/kg in male and female Sprague-Dawley rats therefore we can confirm that the Ethyl Pyruvate is not classified as hazardous for the oral route.