2-ethylcyclopentane-1,3-dione

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:

other: Well documented study according to international accepted guidelines and GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

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:

2-ethylcyclopentane-1,3-dione

EC Number:

212-512-3

EC Name:

2-ethylcyclopentane-1,3-dione

Cas Number:

823-36-9

Molecular formula:

C7H10O2

IUPAC Name:

2-ethylcyclopentane-1,3-dione

Test material form:

solid: crystalline

Details on test material:

Test item: Ethyl-cyclopentanedioneCAS number: 823-36-9Batch number: S41196NPhysical state: Solid, crystalline substanceColuor: Almost whiteActive ingredient content (Calculated): 93.7%Storage: At a temperature of 15 to 30 °C

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): 183 - 188 gBody weight range at starting (second step): 190 - 194 gAcclimatization time: 6 days in first step and 7 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: Methylcellulose (0.5 %) aq. solution

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 (2134 mg/kg bw before dose correction) of the Ethyl-cyclopentanedione 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. As the active ingredient content of the test item was below 95%, dose correction was applied, and 213.4 mg test item was added to every mL of dosing suspension to reach 200 mg/mL ethyl-cyclopentanedione concentration. Formulation was prepared just before the administration and 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:

The observation period was 14 days. 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 hte end of the observation period rats were sacraficed and necropsy were performed.

Results and discussion

Effect levels

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 Ethyl-cyclopentanedione. All female rats in step 1 and step 2 survived until the end of the 14-day observation period.

Clinical signs:

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

Body weight:

The mean body weight of animals corresponded to their species and age throughout the study.

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
	Test item	Dose (mg/kgbw)	Females
1	“Ethyl-cyclopentanedione” Step 1	2000	0/3
2	“Ethyl-cyclopentanedione” Step 2	2000	0/3

 

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The method used, was not intended for the precise calculation of a precise LD50 value.The result of the test was not conclusive to confirm GHS Category V, because there wasn't any mortality observed at 2000 mg/kg bw.The test item can not be classified.