Registration Dossier
Registration Dossier
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EC number: 931-251-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Sub-chronic toxicity; oral: NOAEL - Males - 79.6 mg/kg/day; Females - 303.9 mg/kg/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 79.6 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
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 C8 & C10 instead of C10 & C12. 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 with the same substance, with parental animals treated for 16 -19 weeks, resulted in a NOAEL in females of 116 mg/kg/day based on food consumption; gross pathology; organ weights and a NOAEL in males of 78 mg/kg/day based on body weight; food consumption; gross pathology; organ weights; histopathology.
Another two-generation fertility study undertaken on a structurally related substance,1,2 benzene dicarboxylic acid , di C9-C11 alkyl esters which has C-chain lengths of C9, C11 compared to di-undecyl phthalate's C11 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
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