Diethyl ethylmalonate

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:

2015

Report date:

2015

Materials and methods

Test guideline

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diethyl ethylmalonate

EC Number:

205-093-3

EC Name:

Diethyl ethylmalonate

Cas Number:

133-13-1

Molecular formula:

C9H16O4

IUPAC Name:

1,3-diethyl 2-ethylpropanedioate

Test material form:

liquid

Details on test material:

Test item: diethyl ethylmalonateCAS No.: 133-13-1Physical state: colourless liquidStorage: in cool, dry, well-ventilated place

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species and strain: Crl:(WI)Br ratsSource: Toxi Coop Zrt.Hygienic level at arrival: SPFHygienic level during the study: good conventionalNumber of animals: 3 animals/groupSex: Female, nulliparous and non pregnant animalsAge of animals: Young adult rat, 8 weeks old in first and second stepBody weight range at starting (first step): 162 - 169 gBody weight range at starting (second step): 162 - 165 gAcclimatization time: 5 days in first step and 6 days in second stepAnimal health: Only healthy animals were used for the study. Health status was certified by the study director.Housing: Group caging (3 animals/cage)Light: Artificial light, from 6 a.m. to 6 p.m.Temperature: 22 ± 3 °CRelative humidity: 30 - 70 %Ventilation: 10-15 air exchanges/hour by central air-condition system.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Helianthi annui oleum raffinatum

Details on oral exposure:

A single oral administration - followed by a fourteen-day observation period - was performed by gavage.An acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, therefore treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished.The dose used was formulated in the vehicle. Concentration of formulation was adjusted to maintain a treatment volume of 10 mL/kg bw. The test item was applied in a concentration of 200 mg/mL. Formulation was prepared just before the administration and was stirred continuously during the treatment.The day before treatment the animals were fasted. The food but not water was withheld overnight. Animals were weighed before the application and the food was given back 3 hours after the treatment.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 female/dose

Control animals:

no

Details on study design:

Animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h, 5 h and 6 h after the treatment and twice each day for 14 days thereafter.The body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15 with a precision of 1 g.At the end of the observation period rats were sacrificed under isofluran anaesthesia.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred at 2000 mg/kg bw single oral dose of diethyl ethylmalonate (CAS 133-13-1). All female rats in step 1 and step 2 survived until the end of the 14-day observation period.

Clinical signs:

other: No treatment related symptoms were observed throughout the 14-day post-treatment period at any groups of the female animals.

Gross pathology:

All animals survived until the scheduled necropsy on Day 15.No pathological changes were found related to the effect of the test item during the macroscopic examination of animals.

Any other information on results incl. tables

Groups	Treatment		Lethality
	Testitem	Dose(mg/kgbw)	Females
1	DIETHYL ETHYLMALONATE (CAS 133-13-1) Step 1	2000	0/3
2	DIETHYL ETHYLMALONATE (CAS 133-13-1) Step2	2000	0/3

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The method used was not intended for the calculation of a precise LD50 value. The test item was ranked into classes of Globally Harmonized Classification System (GHS) described in the OECD Guideline No. 423.