D,L-DIETHYL TARTRATE

Endpoint summary

Description of key information

Acute toxicity: oral: LD50 > 2000 mg/kg bw (OECD 423, GLP, Key, rel.1)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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.

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

None

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The key study is GLP-compliant and of high quality (Rel.1).

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

Not required for substances at the REACH Annex VII tonnage level.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

Not required for substances at the REACH Annex VII tonnage level.

Additional information

Acute toxicity: oral

A key study was identified on the substance (EVIC, 2010, rel.1). In this acute oral toxicity study (limit test) performed according to OECD Guideline No. 423 and incompliance 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 wereadministered a single oral dose of test item at 2000 mg/kg bw. Animals were then observedfor mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animalswere 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

 

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self classification:

Acute toxicity via Oral route:

Based on the available data 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 adverse effects were observed.

Acute toxicity via Dermal route:

No data was available. Not required for substances at the REACH Annex VII tonnage level.

Acute toxicity (Inhalation):

No data was available. Not required for substances at the REACH Annex VII tonnage level.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.

The criteria for Transient Organ effects (STOT-SE Category 3) according to the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute oral toxicity study.

Specific target organ toxicity: single exposure (Dermal):

No data was available. Not required for substances at the REACH Annex VII tonnage level.

Specific target organ toxicity: single exposure (Inhalation):

No data was available. Not required for substances at the REACH Annex VII tonnage level.