Diethyl tartrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From November 11 to November 17, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD Guideline No. 423 without any deviation.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other 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)

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

Constituent 1

Reference substance name:

Diethyl tartrate

EC Number:

201-783-3

EC Name:

Diethyl tartrate

Cas Number:

87-91-2

Molecular formula:

C8H14O6

IUPAC Name:

diethyl tartrate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Tartrate d’ethyle
- Physical state: Colorless liquid
- Storage condition of test material: Stored at ambient 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: 7 weeks
- Weight at study initiation: 216.6 ± 8.7 g (Day 0 just prior to dosing)
- Fasting period before study: hydric fasting for overnight period before test item administration and diet fasting for approximately 3-4 h after dosing.
- Housing: Animals were housed in groups of up to three in polypropylene cages with wood flakes.
- Diet: food A04-10 SAFE, 89290 Augy, France.
- Water: drinking water, ad libitum.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22±2 °C
- Humidity: 50±20 %
- Air changes: 10 changes / h
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: November 11, 2010 To: November 17, 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: None

MAXIMUM DOSE VOLUME APPLIED: 1.65 ml/kg bw

DOSAGE PREPARATION : Test material was tested undiluted, as supplied.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: based on available data on the test item, 2000 mg/kg bw was selected as the starting dose.

Doses:

- Sighting study: 2000 mg/kg bw
- Main study: 2000 mg/kg bw

No. of animals per sex per dose:

- Sighting study: 3 females/dose
- Main study: additional 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, morbidity and mortality checks were made 0.5, 1, 2, 3 and 4 h after dosing and then at least daily for at least 14 days.
Body weight of each animal was recorded on Day -1 (the day before dosing), on Day 0 (just before 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 sodium pentobarbital 6% followed by bleeding of the femoral artery and subjected to gross necropsy.
- Other examinations performed: clinical signs (Spontaneous activity, Preyer reflex, respiratory effects, convulsions, tremors, temperature, muscle tone, grip strength, palpebral ptosis, mydriasis, salivation, lacrimation, righting reflex, piloerection, diarrhea, lethargy, coma, changes in skin, fur, eyes, mucous membranes and mortality).

Statistics:

None

Results and discussion

Preliminary study:

No mortality was observed at a dose level of 2000 mg/kg bw. A weak piloerection was observed in all the animals only for 4h after dosing with 2000 mg/kg bw. All animals showed expected gains in bodyweight over the 14 day study period at 2000 mg/kg bw.
No abnormalities were noted at necropsy.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: None of the animals died during the study

Mortality:

- No mortality was observed at a dose level of 2000 mg/kg bw.

Clinical signs:

other: - A weak piloerection was observed in all the animals only for 4h after dosing with 2000 mg/kg bw.

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:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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

Executive summary:

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

No mortality were observed at 2000 mg/kg bw. A weak piloerection was observed in all the animals only for 4h after dosing with 2000 mg/kg bw. All animals showed expected gains in bodyweight 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 test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

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