Registration Dossier
Registration Dossier
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EC number: 221-678-6 | CAS number: 3184-13-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-05-09 to 2006-05-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- Non-GLP study
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- L-(+)-2,5-diaminopentanoic acid
- EC Number:
- 221-678-6
- EC Name:
- L-(+)-2,5-diaminopentanoic acid
- Cas Number:
- 3184-13-2
- Molecular formula:
- C5H12N2O2.ClH
- IUPAC Name:
- L-(+)-2,5-diaminopentanoic acid
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot 05019
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stable
Test animals
- Species:
- rat
- Strain:
- other: Crl: CD (SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Age at time of dosing: 7 weeks
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- methylcellulose
- Details on oral exposure:
- VEHICLE
0.5 % methylcellulose
- Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations: 10 min, 30 min, 1 h, 2 h, 4 h, then daily
Weighing: Before dosing, after 1 d, 3 d, 7 d, 14 d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat. (total fraction)
- Mortality:
- No mortality occured.
- Clinical signs:
- other: No symptoms developed throughout the study period.
- Gross pathology:
- Necropsy findings: No changes attributable to the test item were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is practically nontoxic when administered orally.
- Executive summary:
L-(+)-2,5-diaminopentanoic acid was administered in a dose of 2000 mg/kg b.w. to female rats. No mortality occured. On other treatement related observations werde made.
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