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EC number: 271-089-3
CAS number: 68515-47-9
A two year bioassay was conducted in which DIDP was administered in the diet at concentrations of 400, 2000, and 8000 ppm to F344 rats (Cho et al., 2008). The average daily doses of DIDP were reported to be calculated from the body weights and feed consumption data using the concentrations of DIDP in the diet. For doses of 400, 2000, and 8000 ppm, the calculated average daily doses of DIDP over 2 years for male rats reported in the paper are incorrect. Actual exposures for male rats were 21.9, 110.3 and 479.2 mg/kg-bw/day and for female rats 22.9, 128.2 and 619.6 mg/kg-bw/day (personal communication with Wan-Seob Cho). Rats of both sexes exhibited significant decreases in overall survival and body weights, and increases in the relative weights of kidneys and liver with 8000 ppm DIDP. No treatment related neoplastic lesions were observed in the internal organs, including the liver. In addition, measurement of catalase enzyme activity, a marker for cell peroxisome proliferating activity, suggests that DIDP can induce peroxisome proliferation at an early stage (12 weeks of treatment) but fails to maintain the catalase-inducing potential by 32 weeks of treatment. An increased incidence of mononuclear cell leukemia (MNCL) was observed in this study, but MNCL is a common neoplasm in F344 rats, and the observed increased incidence is likely to be a species-specific effect with little or no relevance to humans. Therefore, DIDP was not considered to be carcinogenic at doses up to 8000 ppm in rats.
No classification for carcinogenicity is indicated according to the
general classification and labeling requirements for dangerous
substances and preparations (Directive 67-548-EEC) or the
classification, labeling and packaging (CLP) regulation (EC) No
The High Molecular Weight Phthalate Ester (HMWPE) Category consists of
phthalate esters with an alkyl carbon backbone with 7 carbon (C7) atoms
or greater. The category is formed on the principle that substances of
similar structure have similar toxicological properties. The data
available on high molecular weight phthalates demonstrate that members
of this category have similar biological activities and toxicological
properties; verifying the use of read-across data as an appropriate
approach to characterize endpoints. DTDP (C13) is a
high molecular weight phthalate ester. Where data
maybe lacking for DTDP, DINP (C9) and DIDP (C10), which are also high
molecular weight phthalate esters, are used as read-across substances to
provide toxicological information.
The absence of tumor formation in the carcinogenicity test, and the lack
of genotoxicity, establishes there is minimal concern with regards to
carcinogenicity for DTDP. In regards to peroxisome proliferation, as
noted previously, a marked species difference is anticipated. The
current literature reported that only rats and mice are responsive to
the carcinogenic effects of peroxisome proliferators, while dogs,
non-human primates and humans are essentially non-responsive or
refractory (IARC, 1995; Doull, 1999).
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.
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