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EC number: 271-085-1
CAS number: 68515-43-5
Sub-chronic toxicity; oral: NOAEL - Males - 79.6 mg/kg/day; Females - 303.9 mg/kg/dayWhen corrected for differences in molecular weight between the read-across substance and the registed substance this results in an oral: NOAEL - Males - 87.9 mg/kg/day; Females - 335.5 mg/kg/day
A 90 -day sub-chronic oral toxicity has been undertaken on a
structurally related substance, phthalic acid di-n-octyl, n-decyl ester
(DODP) which has C-chain lengths of C6, C10 compared to di-undecyl
phthalate's C11. The No Observed Adverse Effect level (NOAEL) for males
is considered to be a concentration of 0.1 % in the diet, corresponding
to a mean intake of 79.6 mg/kg bw/day based on hepatotoxic effects shown
as histological changes in the liver and effects on liver enzymes. For
females the NOAEL is considered to be 0.3 %, corresponding to a mean
intake of 303.9 mg/kg bw/day on the basis of increased liver and kidney
weights, effects on liver enzymes and haematological parameters.
A two-generation fertility study undertaken on the substance itself,1,2
benzene dicarboxylic acid , di C9 -C11 alkyl esters, resulted in, for
parental animals, reduced bodyweight gain amongst males and lower food
intake at 10000 ppm, corresponding to a mean daily intake of at least
650 mg/kg/day. At termination, males showed macroscopic liver changes,
although relative liver weight was unaffected, and histopathological
evidence of hepatocyte necrosis and increased rates of cell turnover.
There was no evidence of histopathological effects of treatment upon
other organs although a lower adrenal, thymus and spleen weight was
evident for high dosage females. A dietary concentration of 5000ppm was
regarded as the NOAEL, this corresponding to a dose level of at least
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