Registration Dossier

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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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 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).