Registration Dossier
Registration Dossier
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EC number: 200-773-6 | CAS number: 72-18-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-10-05 to 2005-07-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- L-valine
- EC Number:
- 200-773-6
- EC Name:
- L-valine
- Cas Number:
- 72-18-4
- Molecular formula:
- C5H11NO2
- IUPAC Name:
- L-valine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar outbred rat; Crl:(W1) WU BR
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 152 - 169 g
- Fasting period before study: overnight
- Housing: Maximum of 6 animals per macrolon cage
- Diet (e.g. ad libitum): Ad libitum approx. 4 h after dosing
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
according to guideline
IN-LIFE DATES: From: 2005-06-01 To:2005-06-21
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage):1.5 to 1.7 ml
MAXIMUM DOSE VOLUME APPLIED: 1.7 ml - Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Before dosing, day 3, day 7, day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed.
- Clinical signs:
- other: No clinical signs observed.
- Gross pathology:
- No distinct treatment-related gross alterations
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- L-valine did not cause any mortality in an acute oral toxicity study according to OECD 423. LD50 derived from this limit test was > 2000 mg/kg bw.
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