Registration Dossier

Administrative data

Description of key information

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).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
15 800 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

Additional information

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) category).

Justification for classification or non-classification

Two studies 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.