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Key value for chemical safety assessment

Additional information

There is adequate data to assess the mutagenic potential of LCCPs. LCCPs, like the SCCPs and the MCCPs, do not induce mutations in bacteria. There is some evidence of weak clastogenic potentialin vitroin mammalian cells,withchromosomal aberrations observed in CHO cells (with metabolic activation) and also sister chromatid exchanges (at 5-5000µg/mL with and without activation); however,no evidence of chromosomal aberrations was seen in a well-conductedin vivostudy in rat bone marrow cells, in which the rats received doses of up to 5000 mg/kg bwt/day for 5 days by gavage. There wasalso a negative mouse lymphoma assay conducted by the NTP on C23(average)liquid LCCP.Taking all of the data on LCCPs into account and considering what is known about shorter chain CPs, it is concluded that LCCPs, as a group, are without significantgenotoxicpotential. (From OECD SIAP October 2009)

In summary, LCCPs, like other CPs, do not induce mutations in bacteria. There is some evidence of weak clastogenic potentialin-vitroin mammalian cells, but this is not seenin-vivoin rat bone marrow cells. Taking all of the data on LCCPs into account and considering what is known about shorter chain CPs, it is concluded that LCCPs, as a group, are without significant mutagenic potential.

 

Short description of key information:

Valid studies of liquid grade LCCP products have been shown to be negative in the Ames test, using the Salmonella strains shown below, both with and without metabolic activation. On the other hand, the C23 (average) 43% Cl LCCP product was shown to cause chromosomal aberrations in Chinese hamster ovary (CHO) cells at a concentration of 5000 g/ml with metabolic activation. It also caused sister chromatid exchanges in CHO cells at concentrations ranging from 5.0 to 5000 ug/ml, both with and without metabolic activation.

In vivo, both a C22-26, 43%Cl and a C22-28, 70%Cl LCCP product showed no evidence of chromosome aberrations in rat bone marrow cells (Fischer 344) following the administration of either product by gavage at doses of 500, 1500 or 5000 mg/kg bwt/day for 5 days.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification