L-Carnitine-L-Tartrate

Acute Toxicity: oral

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, performed in conformity with GLP-principles

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Name of test material (as cited in study report): P5497 (identical with L-Carnitine-L-Tartrate)
- Physical state: white, fine powder
- Purity test date: not indicated
- Lot/batch No.: 13
- Stability under test conditions: stable
- Storage condition of test material: ambient temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, 8741 Sulzfeld/Germany
- Weight at study initiation: males: 252-275 g / females: 249-270 g
- Housing: collective housing à 5animals per cage
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): Artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

A 50% solution of the test item in water was administered

Doses:

5000 mg/kg

No. of animals per sex per dose:

Five males and five females

Control animals:

no

Results and discussion

Preliminary study:

A preliminary range finding test with a dose of 5000 mg/kg was conducted on two female rats.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

MALES:
Dose level 5000 mg/kg bw: Number of animals: 5; Number of deaths: 0

FEMALES:
Dose level 5000 mg/kg bw: Number of animals: 5; Number of deaths: 0

Clinical signs:

There were no clinical signs observed throughout the study.

Body weight:

Weight gains were normal in all animals.

Gross pathology:

Effects on organs:
Gross pathological examinations at 14 days p.a. revealed no treatment related findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the results of this study, the LD50 values at 24 hours and 14 days were found to be greater than 5000 mg/kg.

Executive summary:

The test item was tested for acute oral toxicity on rats according to OECD-Guideline No. 401, EU-Testing Method B.1 and in conformity with GLP-principles in 1991. Five males and five females were treated by oral gavage of a single dose of 5000 mg/kg. There wasneither mortalitynor were clinical signs of toxicity observed. There were no effects on organs, too.

In conclusion, the acute oral LD50 on Wistar rats was found to be > 5000 mg/kg. Based on these results, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation according to the European CLP-Regulations (GHS).