Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

No study details or results were located for Santicizer 261A.

 

A number of structurally related phthalates have shown no evidence of mutagenicity in the Ames test. Thus, Santicizer 278, di-isononyl phthalate (DINP) and butyl benzyl phthalate (BBP) were all inactive in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538, when tested at up to 5-12 mg/plate in the presence or absence of a rat liver metabolic activation system (S9) (Environmental Health Laboratory, 1982; Litton Bionetics Inc., 1976; McKee et al. 2000; NTP, 1997d). Negative Ames test results have also been obtained with a number of other high molecular-weight phthalate esters (HMWPEs, with a carbon backbone of C7 or higher) (OECD, 2004).

 

Other in vitro genotoxicity assays on various phthalates also provide similar findings. For example, DINP was inactive in a chromosome aberration test in Chinese hamster ovary (CHO) cells, when tested at up to 160 µl/ml in the presence or absence of rat liver S9 (McKee et al. 2000). Other HMWPEs have been found to be inactive in tests for chromosome aberrations or polyploidy in Chinese hamster lung cells and for mutagenicity in mouse lymphoma tests (OECD, 2004). BBP has shown no convincing evidence of genotoxic activity in chromosome aberration or sister-chromatid exchange (SCE) tests in Chinese hamster ovary cells (NTP, 1997e) or in the mouse lymphoma assay (Litton Bionetics, 1977; NTP, 1997c).

 

DINP and di-isodecyl phthalate (DIDP) did not induce chromosome damage (increased frequency of micronuclei) in the bone marrow erythrocytes of male mice (5/dose) receiving up to 2 and 5 g/kg bw/day, respectively, by stomach tube on 2 consecutive days (McKee et al. 2000; OECD, 2004).

 

BBP has shown only weak genotoxic potential in vivo, in chromosome aberration and SCE assays, following a single intraperitoneal injection of up to 5 g/kg bw in mice (NTP, 1997f). Two other in vivo studies of lower reliability provide no evidence of genotoxic potential. Thus, in a study available in abstract form only (reliability 4), BBP did not induce dominant lethal mutations in the foetuses when two strains of male mice were given three subcutaneous injections of up to 4.6 g/kg bw and mated with untreated females of the same strain. A slight, dose-related reduction in total implants was observed after the first mating period, indicating that the compound was tested at a high enough dose to produce signs of toxicity (a slight reduction in fertility) (Bishop et al., 1987). Another study assigned a reliability code of 3 (not reliable) due to the low test dose used (0.18 mg/kg bw/day) found no evidence of micronucleus induction in the bone marrow of female rats that were treated via the drinking water throughout pregnancy and lactation (Ashby et al. 1997).


Short description of key information:
No genotoxicity data are available on S261a, but in vivo and in vitro studies on structurally related phthalates including DINP, BBP and S278 provide reassurance that genotoxicity is unlikely to be an issue.

Endpoint Conclusion:

Justification for classification or non-classification

Based on the available data on structurally related phthalates, S261a does not need to be classified for mutagenicity under the EU CLP regulations.