Diethyl tartrate

Endpoint summary

Description of key information

Acute toxicity: oral: LD50 female > 2000 mg/kg bw (OECD 423, rats, K, rel.1);
Acute toxicity dermal: no study available
Acute toxicity inhalation: no study available 

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 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.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

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

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

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

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.

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

None

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The key study is GLP compliant and of good quality (Klimisch score = 1)

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: oral

A key study was available (EVIC, 2010, Rel.1). This acute oral toxicity study was performed according to OECD Guideline No. 423 and in compliance with GLP. groups of 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 bodyweights 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

Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP7.

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 as the LD50 is greater than 2000 mg/kg bw.

Acute toxicity via Dermal route:

No data was available.

Acute toxicity (Inhalation):

No data was available.

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 significant health effects were observed immediately or delayed after exposure 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.

Specific target organ toxicity: single exposure (Dermal):

No data was available.

Specific target organ toxicity: single exposure (Inhalation):

No data was available.