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EC number: 701-008-3
CAS number: -
There were no deaths in acute toxicity tests with Santicizer 278, either in rats (oral, given up to 15.8 g/kg bw) or rabbits (dermal, 24-hour application of up to 10 g/kg bw). Studies only available in a brief summary report (reliability code 4), but data considered adequate for assessment. Results indicate that S278 does not need to be classified for acute toxicity. Additional acute toxicity data on high molecular-weight phthalates provide support for this conclusion (OECD, 2004. Draft SIDS Initial Assessment Report on High Molecular Weight Phthalate Esters (HMWPE) category).
Two acute toxicity studies have been
conducted on Santicizer 278, one oral and one dermal (Younger
Laboratories, 1969a,b). Although details of the two studies are only
available in a brief summary report (hence they have been assigned
reliability code 4), the data are considered adequate for assessment.
The oral administration of undiluted
Santicizer 278 to Sprague-Dawley rats (of either sex) by stomach tube at
2.0, 3.16, 5.01, 7.94 or 12.6 g/kg bw, and to 3 male and 2 female rats
at 15.8 g/kg bw resulted in reductions in appetite and slight weakness
for 1-3 days after dosing, but all ten animals survived the 9-day
observation period. At necropsy, two rats had haemorragic areas in the
lungs, and all 6 rats receiving 12.6 g/kg bw and above had gaseous
intestinal tracts. The viscera of animals receiving up to 7.84 g/kg bw
appeared normal. The investigators concluded that the oral LD50 was
greater than 15.8 g/kg bw.
The covered 24-hour dermal application of
undiluted Santicizer 278 to the intact skin of five New Zealand white
rabbits (three females were dosed at 2.51, 6.31 or 10 g/kg bw (one at
each dose), and two males at 3.98 or 10 g/kg bw) resulted in reductions
in appetite at 6.31 or 10 g/kg bw and slight weakness for two days at
the highest dose, but all five rabbits survived the 14-day observation
period. At necropsy, the viscera of all animals appeared normal. The
investigators concluded that the dermal LD50 was greater than 10 g/kg bw
Additional acute toxicity data on high
molecular-weight phthalate esters (HMWPE) indicate that these compounds
(with a carbon backbone of C7 or greater) are of a low order of acute
toxicity by the oral, dermal and inhalation routes of exposure, with
LD50/LC50 values of all tested substances exceeding the maximum amounts
that can be administered to test animals (OECD, 2004. Draft SIDS Initial
Assessment Report on High Molecular Weight Phthalate Esters (HMWPE)
on Santicizer 278 (which are only available in a brief summary report,
reliability code 4) are considered adequate for concluding that the
compound does not need to be classified for acute oral or dermal
toxicity, under the EU CLP regulations.
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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