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Key value for chemical safety assessment

Additional information

Ames test

The mutagenic potential of di-pentaerythritol was evaluated in a GLP study according to OECD method 471 (Jones & Gant, 1992). Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 were exposed to the test material, dissolved in DMSO. No toxicity was observed in a preliminary study conducted at dose levels up to 5000 µg/plate therefore this dose was chosen as the top dose for the main study. No evidence of mutagenic activity was seen at any dose level of di-pentaerythritol in either of two independent mutation tests (in the presence and absence of metabolic activation), when compared to the vehicle controls. It was concluded that di-pentaerythritol was not mutagenic in the in vitro bacterial test system.

Clastogenicity assay

A GLP study was performed to assess the ability of di-pentaerythritol to induce chromosomal aberrations in human lymphocytes cultured in vitro, according to OECD method 473 (Jones et al, 1992). The mitotic index was calculated for all cultures treated with the test substance and the untreated control, on the basis of these data the dose levels selected for the metaphase analysis in both the presence and absence of metabolic activation were 100, 400 and 800 µg/ml. The test material caused no statistically significant increase in the proportion of metaphase figures containing chromosomal aberrations at any dose level when compared with the untreated control. It was concluded that di-pentaerythritol showed no evidence of clastogenic activity in this in vitro cytogenetic test system.

Mammalian cell mutation assay

Di-penta 93 was assayed for mutagenic potential in the mouse lymphoma L5178Y cell line, according to GLP and OECD method 476 (Riach, 2010). The concentration of 2000 μg/mL exceeded the limit of solubility of Di-Penta 93 in the test system. No evidence of mutagenic activity was obtained with Di-Penta 93 in any of the 4 assays. It was concluded that Di-Penta 93 is not mutagenic in mouse lymphoma L5178Y cells, in either the absence or the presence of S9 mix, when tested in dimethylsulphoxide up to and beyond its limit of solubility in the test system.

Di-pentaerythritol has therefore been adequately tested for genetic toxicity according to REACH requirements. The results of the available in vitro studies are all clearly negative, therefore additional testing in vivo is not required.

Justification for selection of genetic toxicity endpoint
A weight of evidence approach is taken to this endpoint: no single study is identified as key

Short description of key information:
No evidence of mutagenicity was seen in an Ames test, a study of clastogenicity in cultured CHL cells and in a mouse lymphoma assay performed with di-pentaerythritol.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The results of the available genetic toxicity studies are negative; no classification is therefore required according to Directive 67/548/EEC or EC Regulation 1272/2008.