Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Assessment of the genotoxicity of the registration substance

The genotoxicity of the registration substance is assessed based on the genotoxicity property of the read-across supporting substance N,N-Bis(2-hyydroxyethyl)-C12-18(even numbered)alkyl-1-amine.

N,N-Bis(2-hyydroxyethyl)-C12-18(even numbered)alkyl-1-amine was tested in three in-vitro genotoxicty studies (Ames test, Chromosome aberration test, Mouse lymphoma assay). There were no indications of any genetic toxicity.

Likewise, no genotoxicity can be derived for the registration substance.

Justification for the proposed read-across approach

The registration substance is the oxidation product of the introduced read-across supporting substance, N,N-Bis(2-hyydroxyethyl)-C12-18(even numbered)alkyl-1-amine. The underlying scientific rationale for the proposed read-across is based on:

(a) The source chemical is a tertiary amine and the target chemical the corresponding tertiary amine oxide, whereby an inter-convertibility within these two chemicals in biological systems can be presumed so that the subsequent metabolism pathway should be identical for both chemicals.

(b) For the verification purpose of the proposed read-across appraoch, the target chemical was investigated for its reproduction toxicity according to the OECD 421, specifically to examine the postnatal fetal effect, because such effects were predictable based on the available data on the source chemical. The outcome of the OECD 421 on the target chemical confirmed the similarity of the toxicity profiles for target- and the source chemicals, which serves here as a crucial bridging evidence.

Further, detailed justification is provided separately in Chapter 13.


Justification for selection of genetic toxicity endpoint
No study has been selected as the conclusion that the substance is not genotoxic/mutagenic is based on the three negative studies, the Ames test, the Mouse Lymphoma and the In-vitro human lymphocyte chromosomal aberration studies

Short description of key information:
The genotoxicity of the registration substance is assessed based on the genotoxicity property of the read-across supporting substance N,N-Bis(2-hyydroxyethyl)-C12-18(even numbered)alkyl-1-amine.
N,N-Bis(2-hyydroxyethyl)-C12-18(even numbered)alkyl-1-amine was tested in three in-vitro genotoxicty studies (Ames test, Chromosome aberration test, Mouse lymphoma assay). There were no indications of any genetic toxicity.
Likewise, no genotoxicity can be derived for the registration substance.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No significant genotoxicity could be derived for the registration substance by use of read-across appoach. The proposed read-across supporting substance did not show any genotoxic acitivity in three in-vitro tests (Ames test, Chromosome aberration test, and Mouse lymphoma assay). Likewise no significant genotoxicity was assigned for the registration substance.

No classification is warranted.