Ethyl 3-[4-(hydroxymethyl)-2-methyl-1,3-dioxolan-2-yl]propanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

November 15th to December 30th, 2011

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Reliability of original study is 1

Justification for type of information:

Justification for Read Across is given in Section 13 of IUCLID.

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:

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

Version / remarks:

adopted October 2008

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

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

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: 2 months
- Weight at study initiation: 180-218 g.
- Fasting period before study: 16-20 h
- Housing: individually housed in suspended stainless steel wire bottom cages. Paper bedding was placed beneath the cages and changed at least three times/week.
- Diet: fresh PMI rat chow.
- Water: ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
The animal room reserved exclusively for rats on acute tests, was temperature-controlled, had a 12 h light-dark cycle, and was kept clean and vermin free.

IN-LIFE DATES: From:23 Nov, 2011 To: 30 Dec, 2011

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.
Initially a single rat was dosed orally by syringe and dosing needle. Since the animal survived, four additional females were dosed.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 females

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: at 15 min, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly, at death and at termination in the survivors.
- Necropsy of survivors performed: yes by using CO2.
- Other examinations performed: Systemic and necropsy observation

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Three out of five female rats survived. The deaths occurred between 2 hours postdose and on Day 1.

Clinical signs:

other: Pre-death physical signs included wetness of the anogenital area, prostration, ataxia and piloerection. Among the survivors, abnormal physical signs included lethargy, wetness of the nose/mouth area, ataxia, piloerection, wetness of the anogenital area, p

Gross pathology:

Necropsy findings revealed wetness of the nose/mouth area, soiling and wetness of the anogenital area, pale areas and redness of the stomach, as well as red and yellow areas on the intestine. There were no necropsy findings in the survivors.

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 > 5000 mg/kg bw.

Executive summary:

The acute toxicity of the test material after the oral exposure to rats was evaluated in a limit test according to the OECD Guideline 425 and EPA OPPTS 870.1100 and n compliance with GLP.

Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, four additional animals were dosed at 5000 mg/kg bw. The animals were observed for 14 days for mortality, clinical signs, body weights were recorded and the surviving animals were necropsied.

Three out of five female rats survived the single 5000 mg/kg bw oral dose.

LD50 > 5000 mg/kg bw.