Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The potential mutagenicity of Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-in bacterial cells has been assessed in vitro in a bacterial reverse mutation assay conducted according to OECD Test Guideline 471 (May, 2008). Negative results were obtained in Histidine-dependent auxotrophic mutants of Salmonella typhimurium, strains TA1535, TA1537, TA98 and TA100, and a tryptophan-dependent mutant of Escherichia coli, strain WP2 uvrA (pKM101), both in the presence and in the absence of metabolic activation in the form of S9 mix.

There are no studies available on the in vitro genotoxicity of Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-. Based on existing datasets, structural and chemical considerations, read-across from the substance to in vitro genotoxicity studies in mammalian cells on Propylidynetrimethanol, ethoxylated (TMP EO) is appropriate to meet the REACH Annex VII-IX data requirements. Read-across is scientifically justified and also enables the REACH requirements to be adequately addressed, while avoiding unnecessary animal testing in accordance with EU Directive 86/609/EEC.

The clastogenic potential of TMP EO in vitro has been investigated in a chromosome aberration test using Chinese hamster V79 cells carried out according to OECD Test Guideline 473 (Nern, 2010). Negative results were observed in the study: TMP EO was not clastogenic.  

The potential for TMP EO to cause gene mutations in mammalian cells in vitro has been investigated in the hypoxanthine-guanine phosphoribosyl transferase locus (HPRT) in V79 cells in a study conducted according to OECD Test Guideline 476 (Entian, 2010). Negative results were obtained in the forward mutation assay with and without metabolic activation (rat liver S9 mix).

Studies on TMP EO do not show evidence of genotoxicity in mammalian cells in vitro. Based on read-across to these studies, Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-is not predicted to have genotoxic potential in mammalian cells in vitro.

In accordance with column 2 of REACH Annex VIII, as the available in vitro studies did not reveal any genotoxic potential for the substance, in vivo genetic toxicity studies are not necessary.


Justification for selection of genetic toxicity endpoint
No study was selected since negative results were obtained in a study using the substance in vitro and in in vitro studies using the read-across substance TMP EO.

Short description of key information:
No evidence of mutagenicity was seen for Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy- in a bacterial reverse mutation assay (Ames test). Based on available datasets and chemical and structural considerations, read across from the substance to mammalian in vitro genotoxicity studies on Propylidynetrimethanol, ethoxylated (TMP EO) is appropriate to address the REACH Annex VII-VIIII data requirements. Based on read-across to in vitro cytogenicity or gene mutation studies on TMP EO, no genotoxicity in mammalian cells is predicted for the substance.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy- is not mutagenic in bacterial cells in vitro. Based on read-across to available in vitro cytogenicity and gene mutation studies conducted using Propylidynetrimethanol, ethoxylated (TMP EO), the substance is not predicted to have genotoxic potential in mammalian cells in vitro. The substance does not meet the criteria for classification for genotoxicity according to Directive 67/548/EEC or Regulation 1272/2008/EC.