Registration Dossier
Registration Dossier
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EC number: 205-702-2 | CAS number: 147-85-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983-03-10 to 1983-04-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Intercomparison Study on the Determination of Single Administration Toxicity in Rats, Commission of the European Communities, Health and Safety
Directorate, J. Assoc. Off. Anal. Chem. 62, 864-873, 1979 - GLP compliance:
- no
- Remarks:
- Study performed prior to implementation of GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- L-proline
- EC Number:
- 205-702-2
- EC Name:
- L-proline
- Cas Number:
- 147-85-3
- Molecular formula:
- C5H9NO2
- IUPAC Name:
- L-proline
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: males 48 - 51 days, females 55 - 62 days
- Weight at study initiation: males 129 - 135 g, females 129 - 138 g
- Fasting period before study: 16 hours
- Housing: Makrolon cages type II
- Diet (e.g. ad libitum): standardised test animal diet ALTROMIN
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days acclimatisation period before study begin
ENVIRONMENTAL CONDITIONS
According to method
IN-LIFE DATES: From: To: no data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 238 mg/ml
- Amount of vehicle (if gavage): 21.5 ml/kg
- Justification for choice of vehicle: solubilty, inherent vehicle
- Lot/batch no. (if required): not applicable
- Purity: ca. 100 %
MAXIMUM DOSE VOLUME APPLIED: 21.5 ml/kg - Doses:
- 5110 mg/kg
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data available
- Necropsy of survivors performed: no data vailable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the observation period of 14 days.
- Clinical signs:
- other: No signs of toxicity were observed either at the male nor the female animals.
- Gross pathology:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The LD50 value of L-proline via the oral route represented by male and female rats was > 5110 mg/kg body weight.
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