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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Bor: WISW (SPFCpb)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co.KG
- Age at study initiation: males 9 weeks; females 10 weeks
- Weight at study initiation: males 155 - 202 g; females 144 - 158 g
- Fasting period before study: 16 hours before treatment
- Housing: individually in Macrolon cages, type II
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 40 - 60 for short periods down to 25
- Photoperiod: 6 a.m. - 6 p.m. artificial lighting; 6 p.m. - 6 a.m. natural light-dark-rhythm

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 237 mg/ml
- Amount of vehicle (if gavage): 21.5 ml/kg
- Lot/batch no. (if required): E0844357
Doses:
5110 mg/kg bw
No. of animals per sex per dose:
5 males + 5 females / dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
coninously observed for the first 4-6 hrs after administration; Mortality: twice daily; weighing at the beginning and also 7 and 14 days after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 110 mg/kg bw
Mortality:
no mortality
Clinical signs:
no clinical signs
Body weight:
no data
Gross pathology:
no alterations were found

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
under the conditions of the study no acute toxic effect occurred after oral application of 5110 mg/kg bw L-Alanyl-L-glutamine