Registration Dossier

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:
1982

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

Constituent 1
Chemical structure
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

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.