D,L-DIETHYL TARTRATE

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From August 24 2010 to October 1st 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 December 2001

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

D,L-DIETHYL TARTRATE

EC Number:

629-770-1

Cas Number:

57968-71-5

Molecular formula:

C8H14O6

IUPAC Name:

D,L-DIETHYL TARTRATE

Test material form:

liquid

Details on test material:

- Physical state: Liquid very slightly yellow
- Storage condition of test material: at room temperature protected from light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: JANVIER, 53940 Le Genest-St-Isle, France.
- Age at study initiation: approximately 7 weeks
- Weight at study initiation: 209.8-218.5 g (first three animals weighted on Day 0).
- Fasting period before study: Animals were fasted for overnight period before administration of test
material and for approximately 3-4 h after dosing.
- Housing: Animals were housed in groups of up to 3 in polypropylene cages
- Diet: Food, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Humidity: 30-70 %
- Air changes: 10 changes/h
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: August 2010 To: September, 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: None

MAXIMUM DOSE VOLUME APPLIED: not reported

DOSAGE PREPARATION: Test material was administered as received (liquid)

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using available information on the toxicity of the test material, 2000 mg/kg bw was chosen as the starting dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

- First experiment: 3 females/dose
- Second experiment: 3 females/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were made 0.5, 1, 2 and 4 h after dosing and then daily for up to 14 days.
Body weight of each animal was recorded on Day -1, Day 0 (the day of dosing) and on Days 3, 7 and 14.
- Necropsy of survivors performed: Yes; on completion of the observation period, animals were killed by intraperitoneal injection of pentobarbital 6% and bled, and then subjected to gross necropsy.

Statistics:

None

Results and discussion

Preliminary study:

Following a first study using three animals at a dose level of 2000 mg/kg bw, additional 3 animals were administered a single oral dose of test item at 2000 mg/kg bw.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

- No mortality was observed at 2000 mg/kg bw.

Clinical signs:

other: - A very slight piloerection was observed during the first 30 minutes. No other signs were observed until the end of the observation period.

Gross pathology:

- No abnormalities were noted at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the substance is not classified according to the Regulation EC No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw and no significant adverse effects were observed.

Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline No. 423 and in compliance with GLP, female Sprague-Dawley strain rats were administered a single oral dose of test material by gavage. Following a first study using three animals at a dose level of 2000 mg/kg bw, additional 3 animals were administered a single oral dose of test item at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

No mortality was observed. A very slight piloerection was observed during the first 30 minutes. No other signs were observed until the end of the observation period. All animals showed expected gains in body weight over the 14 day study period. No abnormalities were noted at necropsy.

 

Rat Oral LD50 (females) > 2000 mg/kg bw

 

Under the test conditions, the substance is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS as the oral LD50 is higher than 2000 mg/kg bw and no significant adverse effects were observed.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.