Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Trimethylolpropane was tested using the Ames test according to OECD TG 471 and GLP and showed no mutagenic activity with and without exogenous metabolic activation up to 5000 µg/plate, but cytotoxicity was not reached (MHLW 1994). This result confirmed the result of an investigation of Bayer AG, 1989 when trimethylolpropane was investigated in the Salmonella/microsome test (Ames test) in doses up to 5000 µg per plate on Salmonella typhimurium strains TA98, TA100, TA1535 and TA 1537: according to Ames et al. Mut Res 31, 347-364 (1975) and GLP.There was no evidence of mutagenic activity of trimethylolpropane with and without mutagenic activation, but cytotoxicity was not reached .

In addition, a study was performed to investigate the potential of trimethylolpropane (TMP) rein to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamsters according to OECD TG 476 and GLP in concentrations up to 1400 µg/ml in the presence and in the absence of S9 -mix. Cytotoxicity was determined in preliminary experiments. Under the conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore , Trimethylolpropane (TMP) rein is considered to be non-mutagenic in this HPRT assay (Harlan CCR 2010)

According to OECD TG 473 and GLP trimethylolopropane was tested for chromosomal aberration with Chinese Hamster Lung (CHL) cells and concentrations up to 1.34 mg/ml in the presence and in the absence of a metabolic activation system. There was no evidence for clastogenic activity neither with nor without S9 -mix (MHLW 1994).


Justification for selection of genetic toxicity endpoint
An Ames test, a chromosome aberration test and a HPRT test are available.

Short description of key information:
Trimethylolpropane revealed no mutagenic activity in the Ames Test according to OECDTG 471 and GLP and is considered as non-mutagenic when tested according to OECD TG 476 and GLP (HPRT-test, Chinese Hamster V79 cells).
Trimethylolpropane revealed no clastogenic activity when tested in Chinese Hamster Lung (CHL) cells according to OECD TG 473 and GLP.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Directive 67/548/EEC, Annex 1,trimethylolpropane is not classified

Directive 67/548/EEC, Annex 1 and Regulation (EC) No. 1272/2008:

Based on the available data no classification has to be required.