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EC number: 941-453-2 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline 401 (1987) and Council Directive 92/32/EEC
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 92/32/EEC
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- L-Threonine mother liquor
- IUPAC Name:
- L-Threonine mother liquor
- Details on test material:
- -Name of test material (as cited in study report): L-Threonine containing mother liquor
Details are presented in "Confidential details on test material"
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Hsd/Win:WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Harlan-Winkelmann GmbH, Germany
-Age at study initiation: 8 - 9 weeks
-Weight at study initiation: 144 - 163 g
-Fasting period before study: ca. 16 hrs before treatment
-Housing: Individually in Macrolon type II cages
-Certified diet ad libitum
-Tap water ad libitum
-Acclimation period: At least 5 days before dosing
ENVIRONMENTAL CONDITIONS
According to guideline
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED
-Dosing volume: 4.64 mL/kg bw (only one dose level tested)
-Concentration: 464 mg/mL - Doses:
- 2150 mg/kg bw
- No. of animals per sex per dose:
- 5 m / 5 f
- Control animals:
- other: not required
- Details on study design:
- -Duration of observation period following administration: 14 days
-Frequency of observations:
Clinical signs: Continuously for the first 4 – 7 h, then once daily
Mortality: 1 – 2 times daily
Body weights: At beginning and on days 7 and 14 after dosing
Gross necropsy: all animals
No other examinations performed - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 150 mg/kg bw
- Mortality:
- no
- Clinical signs:
- other: Sunken sides in 3/5 males and 5/5 females. Red incrustrated eyes and nose in 1/5 males. Symptoms were observed between 98 min and 8 days of observation.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The acute oral toxicity of L-threonine mother liquor was tested in GLP study according to OECD guideline 401. In both male and female Hsd/Win:WU rats the oral LD50 is > 2150 mg/kg bw.
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