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Toxicological information

Additional toxicological data

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Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
The sensitivity of metabolomics versus classical regulatory toxicology from a NOAEL perspective
Author:
van Ravenzwaay, B.; Montoya, G. A.; Fabian, E.; Herold, M.; Krennrich, G.; Looser, R.; Mellert, W.; Peter, E.; Strauss, V.; et al.
Year:
2014
Bibliographic source:
Toxicology Letters, (2014) Vol. 227, No. 1, pp. 20-28.

Materials and methods

Type of study / information:
Metabolome investigation
Principles of method if other than guideline:
Analysis of potential changes in 251 endogenous plasma components after subacute oral exposure.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid/violet to dark blue
- Analytical purity: 96.84 %
- Expiration date of the lot/batch: 04. Feb. 2021
- Stability: The stability of the test substance under storage conditions over the test period was guaranteed by the sponsor. The stability of the test substance in drinking water at room temperature over a period of 7 days and the homogenous distribution of the test substance in drinking water was confirmed by analysis.
- Storage condition of test material: room temperature

Results and discussion

Any other information on results incl. tables

No relevant changes in metabolome parameters between the test material and control goup rats were identified, and the NOEL is the highest tested dose of 1000 mg/kg bw.

Applicant's summary and conclusion

Conclusions:
No adverse effects on endogenous plasma parameters were identified at the limit dose of 1000 mg/kg bw..