Ethyl L-threoninate

Acute Toxicity: oral

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Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 24, 2000 - May 30, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

NA

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Threonineethylester
- Analytical purity: 97%
- Purity test date: No data
- Lot/batch No.: 142-576-6
- Expiration date of the lot/batch: No data
- Stability under test conditions: Considered to be stable during testing
- Storage condition of test material: Frozen

Specific details on test material used for the study:

- Name of test material (as cited in study report): Threonineethylester
- Analytical purity: 97%
- Purity test date: No data
- Lot/batch No.: 142-576-6
- Expiration date of the lot/batch: No data
- Stability under test conditions: Considered to be stable during testing
- Storage condition of test material: Frozen

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Preparation of a nanomaterial dispersion (incl. dilution):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

OTHER SPECIFICS
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is added:
- other information:

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:Wl(Glx/BRL/han)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: 285-319g (males), 178-194g (females)
- Fasting period before study: overnight prior to dosing
- Housing: suspended stainless steel mesh cages
- Diet (e.g. ad libitum): ad libitum, except overnight prior to dosing and three hours after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 or 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 40-70 % RH
- Air changes (per hr): 12 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours daily with flurorescent strip-lights

IN-LIFE DATES: From 11 April or 9 May 200 to 30 May 2000

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Purified water from on site Elgastat purifier.

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Dispersed in purified water to reach 10/20 mL/kg bw
- Justification for choice of vehicle: solubility

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg (males) and 20 mL/kg (females)

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Dose selection followed the Acute Toxic Class procedure detailed in EC and OECD guidelines.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at least daily, weighing on Day -1, 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,necropsy

Statistics:

NA

Results and discussion

Preliminary study:

NA

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

other: No clinical signs was observed

Gross pathology:

No macroscopic changes were observed for animals killed on Day 15.

Other findings:

- Organ weights: Not performed
- Histopathology: Not performed
- Potential target organs: None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The acute oral toxicity of L-TEE was assessed in rats following a single administration of L-TEE. The study was performed in compliance with OECD guideline 423 and ECC guideline B1 tris. The acute oral median lethal dose (LD50) of L-TEE was estimated to be greater than 2000 mg/kg bw.

Executive summary:

This study was conducted to assess the acute toxicity of L-TEE following a single oral administration of 2000 kg/kg bw. It was designed to meet the known requirements of the testing guidelines ECC (B1 tris); OECD (423) and US EPA OPPTS 870.1100.

Groups of three male or three female fasted rats were given L-TEE as a single dose on Day 1 by oral gavage at a dose level of 2000 mg/kg. L-TEE was dispersed in purified water and administered at a dose volume of 10 or 20 mL/kg.

All animals were killed on Day 15 and subsequently underwent a full necropsy. There were no deaths. No clinical signs of reaction to treatment were noted and there were no effects on body weight gain. Macroscopic examination of the animals revealed no abnormalities.

Following a single administration of L-TEE to rats, the acute median lethal oral dose was found to exceed 2000 mg/kg.