L-threonine, fermentation products byproduct

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to OECD guideline 423 (adopted 2001)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Remarks:

(Harlan Laboratories Ltd.)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(2S)-2-amino-3-hydroxybutanoic acid

EC Number:

923-725-2

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

(2S)-2-amino-3-hydroxybutanoic acid

Details on test material:

- Name of test material (as cited in study report): Biofert Plusz
Details are presented in "Confidential details on test material"

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories Ltd.
- Age at study initiation: 11 weeks
- Weight at study initiation: 183.6 – 202.9 g
- Fasting period before study: fasted for approximately 17 to 18 hours
- Housing: In groups of three in Makrolon type-4 cages
- certified diet ad libitum
- tap water ad libitum
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
according to guideline

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: The dosing volume was 7.12 mL/kg body weight (only one dose level, undiluted test substance, corresponding to 2000 mg/kg bw dry mass).
Two groups of three animals each were trested. The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight (dry mass) after being fasted for approximately 17 to 18 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.

Doses:

2000 mg/kg bw (dry mass)

No. of animals per sex per dose:

2 x 3 females

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations (clinical signs): Daily during the acclimatisation period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 and twice daily during days 2-15.
- Frequency of weighing: On test days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes
- No other examinations performed

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

other: related to dry mass

Remarks on result:

other: No clinical signs and no macroscopic findings at the limit dose

Mortality:

no

Clinical signs:

other: No clinical signs were observed during the course of the study.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

In female Wistar rats the oral LD50 is > 2000 mg/kg bw (related to dry mass).