Registration Dossier

Administrative data

Description of key information

Sub-chronic toxicity; oral: NOAEL - Males - 79.6 mg/kg/day; Females - 303.9 mg/kg/day
When 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

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
79.6 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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 300 mg/kg/day.


Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver

Justification for classification or non-classification