Registration Dossier

Toxicological information

Specific investigations: other studies

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

Renal lesions associated with 2,4,4 -trimethylpentene administration were induced by alpha-2u-globulin and are therefore not relevant for human risk assessment.

Additional information

In an oral developmental / reproductive toxicity study on 2,4,4 -trimethylpentene (>95% pure) an increased incidence of hyaline droplets in the proximal tubules of the kidney in male, but not female rats was reported (HLS, 1997c). An investigative study used kidney sections from the original study to determine if the hyaline droplets observed in the original study were composed of alpha-2u-globulin using mouse anti-alpha-2u-globulin monoclonal antibodies (Swenberg and Schoonhoven, 2004 ).

These investigative studies identified that 2,4,4 -trimethylpentene, like structural analogues, produced alpha-2u-globulin nephropathy in male rats. Alpha-2u-globulin nephropathy is a male rat-specific toxicity and is not relevant to human risk assessment.