Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 287-401-6
CAS number: 85507-79-5
Sub-chronic toxicity; oral: NOAEL - Males - 79.6 mg/kg/day; Females - 303.9 mg/kg/day
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 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 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 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 nominal
daily intake of 1000 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 nominal dose
level of 500 mg/kg/day.
No significant toxicity was observed in
males at a dietary inclusion level of 0.1% and in females at a dietary
inclusion level of 0.3% in a repeat dose study of 90 days duration.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again