1,4-Butanediyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 13th, 2011 to January 11th, 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-{[3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoyl]oxy}butyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate

EC Number:

700-652-2

Cas Number:

1259300-69-0

Molecular formula:

C20H34O8

IUPAC Name:

4-{[3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoyl]oxy}butyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAGE Labs, Boyertown, PA.
- Females nulliparous and non-pregnant: yes.
- Age at study initiation: almost 2 months old.
- Weight at study initiation: pretest body weight range was 211 - 239 g. The weight variation of the animals used did not exceed ±20% of the mean weight of the previously dosed animals.
- Fasting period before study: 16-20 hours prior to dosing.
- Housing: individually housed in suspended stainless steel wire bottom cages. Paper bedding was placed beneath the cages and changed at least three times per week.
- Diet: fresh PMI Rat Chow (Diet #5012) was freely available.
- Water: ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 h light/dark cycle.
- Other: animal room was clean and vermin free.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test substance was used as received and the dose was based on the sample weight as calculated from the specific gravity.

Dosing: initially, a single female Sprague Dawley rat was dosed orally at a dose level of 5000 mg/kg bw. Since the animal survived, two additional females were dosed at 5000 mg/kg bw.

Doses:

5000 mg/kg bw.

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: animals were observed at 15 minutes, 1, 2 and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects. Animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination.
- Post Mortem: all animals were humanely sacrificed using CO2 following study termination and examined for gross pathology.
- Analysis of Data: an estimate of the LD50 was made based on the mortality occurring during the study.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

act. ingr.

Mortality:

all three female rats survived the single 5000 mg/kg oral dose.

Clinical signs:

other: Wetness/soling of the anogenital area, piloerection, ataxia, splayed hind limbs, sensitivity to touch and few feces were observed.

Gross pathology:

The gross necropsy of all animals revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:

other: not classified as harmful/toxic according to the CLP Regulation (EC) No.1272/2008

Conclusions:

LD50 (rat) > 5000 mg/kg bw

Executive summary:

The acute toxicity effects of the substance and the determination of the test substance in rat was assessed according to EPA OPPTS 870.1100 and OECD Guideline 425 in compliance with GLP.

Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, two additional animals were dosed at 5000 mg/kg bw. Animals were observed at 15 minutes, 1, 2 and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects. Animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination. All animals were humanely sacrificed using CO2 following study termination and examined for gross pathology. No mortality was observed under the test conditions.

Under the conditions of the study, the LD50 of the test substance was > 5000 mg/kg bw.