Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 March 2002 - 5 April 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

22 March 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

January 1997

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate

EC Number:

228-536-2

EC Name:

Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate

Cas Number:

6290-17-1

Molecular formula:

C9H16O4

IUPAC Name:

ethyl 2-(2,4-dimethyl-1,3-dioxolan-2-yl)acetate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: stock SHOE:WIST, Tierzucht Schonwalde GmbH
- Females nulliparous and non-pregnant: not indicated
- Age at study initiation: not indicated
- Weight at study initiation: 145-151 g
- Fasting period before study: aprox. 18 hours prior to dosing
- Housing: transparent polycarbonate cages, with two or three in each cage, males and females separated.
- Diet: pelleted complete rodent diet "Altromin 1314" from Altromin GmbH, ad libitum
- Water: free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 21°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20-March-2002 To: 4-April-2002 (males) and From: 22-March-2002 To: 6-April-2002 (females)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: according to guidelines.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the starting dose was chosen in accordance with OECD guideline 423.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3 males and 3 females, both receiving the highest dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 3 and 6 hours after the administration and thereafter daily
- Frequency of weighing: on days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and pathological findings

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: - Males: Animals No. 1, No. 2 and No. 3 showed decreased motor activity, a pinched abdomen and piloerection 1 and 3 hours after the application of the test article. After 6 hours a pinched abdomen and piloerection were observed in the three animals, where

Gross pathology:

No pathological abnormalities were found after gross necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not acute harmful.

Remarks:

In accordance with EU CLP (EC. No. 1272/2008 and its amendments).

Conclusions:

Under the experimental conditions described in this report, the oral LD50 of the substance in rats was found to be above 2000 mg/kg bw. Therefore, the substance is considered to be not acute harmful.

Executive summary:

In this study performed according to OECD TG 423 guideline and GLP principles, 6 rats (3 males and 3 females) were administered with the substance at a dose level of 2000 mg/kg bw. Observations were made for 14 days after dosing. No mortality occurred. Pinched abdomen and piloerection was observed in all animals until 6 hours after dosing. From day 1 until the end of the study, no abnormal clinical signs were observed. Rats showed a normal weight gain during the study period. No pathological abnormalities were found after gross necropsy. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw.