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Additional information

Thiodiglycol did not induce reverse gene mutations in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and E. coli WP2uvrA at concentrations up to 5 mg/plate in the presence or absence of metabolic activation (according to current guideline, USACHPPM 2001). These results are confirmed by a 2nd assay in Salmonella typhimurium TA98, TA100, TA1535, TA1537 (BASF 1989). In a cytogenetic assay on CHO cells (comparable to OECD guideline 473; USACHPPM 1997) thiodiglycol was tested at high dose levels between 1 and 5 mg/ml. An increased number of aberrations like chromosome and chromatid breaks as well as chromatid type rearrangements were detected. The effects were significant at 5 mg/ml without metabolic activation and at ≥ 4 mg/ml with metabolic activation. No effects were recorded on the cell density but the mitotic index was significantly decreased at concentration ≥ 1 mg/ml. In contrast to the cytogenetic assay no mutagenic activity was found in the mouse lymphoma assay (according to OECD guideline 476; this assay also detects clastogenic effects) at concentrations between 0.05 and 5 mg/ml thiodiglycol, both in the presence and in the absence of a metabolic activation system. No cytotoxicity was observed without metabolic activation and only slight effects without dose dependency in the presence of the metabolic activation system (USACHPPM 1998). Furthermore, no clastogenic effects were observed in vivo using the mouse bone marrow micronucleus assay (USACHPPM 2001; according to OECD Guideline 474). Six male mice per dose were gavaged once with 0, 500, 1000, or 2000 mg/kg bw and bone marrow prepared for evaluation 24 and 48 h after application. No increase in the frequency of micronuclei was detected. No clinical toxicity or cytotoxic effects on the bone marrow were found even at 2000 mg/kg. It is therefore concluded that the clastogenic effects seen in vitro are not expressed in vivo.

Short description of key information:
A documentation and evaluation of available data on this endpoint is presented in:
Thiodiglycol, SIDS Initial Assessment Report for SIAM 19, final version 10/2006.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

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