Registration Dossier
Registration Dossier
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EC number: 200-273-8 | CAS number: 56-41-7
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- June 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: other guideline: "Depressor Substances Test" USP XX (1980)
- Deviations:
- not specified
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- L-alanine
- EC Number:
- 200-273-8
- EC Name:
- L-alanine
- Cas Number:
- 56-41-7
- Molecular formula:
- C3H7NO2
- IUPAC Name:
- L-alanine
Constituent 1
Test animals
- Species:
- cat
- Strain:
- other: crossbreed
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: D.WENZEL, Detmold, Germany
- Age at study initiation: no data
- Weight at study initiation: male 3.3 kg, female 2.2 kg
- Fasting period before study: 16 hours
- Housing: individually in cages with 1 m² floor area
- Diet (e.g. ad libitum): 66% lean meat, 23% oat flakes, 11% cooked vegetables (own production); 50 g/kg bw /day for 1 h
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days acclimatisation period before study begin
ENVIRONMENTAL CONDITIONS
According to method
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- other: 0.9% solution of NaCl
- Doses:
- consecutive intravenous application of test substance in ascending doses of 10.0, 30.0 and 100.0 mg/kg bw, alternating to intravenous application of histamine-base 10 µg/kg bw
- No. of animals per sex per dose:
- 1
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 5 min
- Frequency of observations and weighing: observation of blood pressure just before application and observation of maximum value after application of test substance
- Necropsy of survivors performed: no data vailable
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data vailable
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- other: influence of L-alanine on histamine-like antihypertensive effect on narcotized cats
- Effect level:
- 10 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no influence on histamine-like antihypertensive effect; see: any other information in the result
- Sex:
- male/female
- Dose descriptor:
- other: influence of L-alanine on histamine-like antihypertensive effect on narcotized cats
- Effect level:
- 30 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no influence on histamine-like antihypertensive effect; see: any other information in the result
- Sex:
- male/female
- Dose descriptor:
- other: influence of L-alanine on histamine-like antihypertensive effect on narcotized cats
- Effect level:
- 100 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no influence on histamine-like antihypertensive effect; see: any other information in the result
- Mortality:
- No mortality occured during the observation period
- Clinical signs:
- No signs of toxicity were observed, neither at the male nor the female animals
- Body weight:
- no data available
- Gross pathology:
- no data available
Any other information on results incl. tables
L-alanine has no influence on histamine-like antihypertensive effect on cats.
No acute toxic effects were observed in intravenous application of L-alanine up to a maximum dose of 100 mg/kg bw.
Applicant's summary and conclusion
- Conclusions:
- No acute toxic effects were observed after intravenous application of L-alanine up to a maximum dose of 100 mg/kg bw in cats. This indicates a low systemic toxicity of L-alanine and is an additional justification for waiving of an acute dermal toxicity study as to Annex VIII REACH.
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