Reaction mass of L-alanyl-L-glutamine and potassium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted according to the OECD guideline 401 and is fully GLP-compliant. As no study for the reaction mass of L-alanyl-L-glutamine and potassium chloride is available, studies conducted with the two main components L-alanyl-L-glutamine and potassium chloride (such as this) were used for read-across in order to avoid unnecessary repitition of testing. As no synergistic or antogonistic effects from either of the main components is expected, the information derived from both main components is considered to be reliable for classification of the reation mass of L-alanyl-L-glutamine and potassium chloride.

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.