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Description of key information

No immunological effects are seen in any of the repeated dose toxicity studies (90 -day oral gavage study in rat; Extended One Generation Reproductive Toxicity study (OECD TG 443); 90 -day dermal toxicity studies in rat and mice; 28 -day oral gavage study in rat) and therefore there is no immunotoxicity concern for OTNE.

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

Based on all available repeated dose toxicity information for the substance there are no immunotoxic findings for this substance. Therefore, for this substance no classification and labelling is needed for this endpoint according to EU CLP (EC 1272/2008 and its amendments).