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Description of key information

Oral immunotoxicity study, mice (not according to OECD guidelines): 

Key value for chemical safety assessment

Effect on immunotoxicity: via oral route

Endpoint conclusion
Dose descriptor:
5 000 mg/kg bw/day

Additional information

Mice were exposed by oral gavage to RDP for 28 days to study immunotoxicity. Dose levels were 500, 1500 and 5000 mg/kg bw/day. Controls were sham exposed and positive controls were included. Several immunological related organs, cells and parameters were studied.

No significant differences in absolute or relative spleen or thymus weights were found. No effect of test substance was noted in spleen or thymus cellularity or peritoneal cell numbers or viability. Histopathology of thymus, spleen, mandibular, mediastinal and mesenteric lymph nodes showed no test substance-related changes. No change in splenic natural killer cell activity was observed. No change in splenic antibody forming cell function was found. No difference in peritoneal macrophage phagocytic activity was observed. No change in susceptibility to Listeria monocytogenes infection was observed. The positive control mice showed significant signs of immunotoxicity/mortality (decreased AFC and mean survival time, increased mortality).

Under the conditions of this study, Fyrolflex RDP produced no adverse effects on immunologic function in mice. A NOAEL for immunotoxicity of 5000 mg/kg bw/day could therefore be established.

Justification for classification or non-classification

Based on the available information, RDP does not have to be classified according to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC), and outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).