Registration Dossier

Administrative data

Description of key information

No experimental data available/ conduct of study scientifically not necessary, please refer to the attached justification for data waiving

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vitro
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
2-oxoglutaric acid is a physiological and indispensable constituent in every living cell. It is a substrate for the tricarboxylic acid cycle and thus, modulates directly ATP generation. Although 2-oxoglutaric acid probably causes a structural alert in the most QSAR predictions, due to its fast metabolism and its ubiquitous occurrence, the initiation of sensitisation is unlikely. Therefore, and for reasons of animal welfare testing of sensitising properties is scientifically not justified. For a detailed justification please refer also to the attached justification for adaption of the registration information requirements.
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on available adequate and relevant information, the test item is considered to be not a Skin sensitizer and thus does not need to be classified and labeled according Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).