Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In a guideline bacterial gene mutation study (Ames),of BASF AG, 2-(2-(2-butoxyethoxy)ethoxy)ethanol (87% pure) did not cause an increase in mutations when tested at up to 5mg/plate with and without S9 metabolic activation using both a standard plate incorporation and pre-incubation methods of application. The test substance does not cause reverse gene mutation in bacterial strains.

Read-across data from supporting substance (structural analogue or surrogate) also indicate negative genetic toxicity



Short description of key information:
There are conclusive but not suffcient data for the classification of substance 2-(2-(2-butoxyethoxy)ethoxy)ethanol with regard to mutagenicity/genetic toxicity.
It is concluded that the substance2-(2-(2-butoxyethoxy)ethoxy)ethanol does not meet the criteria to be classified for human health hazards for Mutagenicity-Genetic Toxicity

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the hazard assessmentof2-(2-(2-butoxyethoxy)ethoxy)ethanolin section 2.1 and 2.2. in IUCLID 5.3., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:

Directive 67/548

Mutagenicity-Genetic Toxicity

Muta. Cat. 1; R46 May cause heritable genetic damage.

Muta. Cat. 2; R46 May cause heritable genetic damage.

Muta. Cat. 3; R68 Possible risk of irreversible effects.

CLP

Germ cell mutagenicity

Muta. 1A

Muta. 1B

Muta. 2

H340: May cause genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.

H341: Suspected of causing genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.

   

It is concluded that the substance2-(2-(2-butoxyethoxy)ethoxy)ethanol does not meet the criteria to be classified for human health hazards for Mutagenicity-Genetic Toxicity