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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

One study on gene mutation in bacteria (Bichet, 1981f) is available for the substance (Amines, N-tallow alkyltrimethylenedi-, propoxylated)

showing a negative result. An additional in vivo study on chromosome aberration is available, giving a negative result (Boutemy, 1981g). The endpoint gene mutation in mammalian cells is covered by read across from a respective study conducted with the structurally closely related substance (see the justification paper attached in the Summary "Toxicological Information" of the IUCLID) 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs (Singh, 2010c read across from Polyram SL).

The potential toxicophoric groups present in the former are present in the latter. Based on this close structural relation between the two test items the negative result concerning gene mutation in mammalian cells for 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino] propyl]imino]bis-, N-tallow alkyl derivs. can be extrapolated to Amines, N-tallow alkyltrimethylenedi-, propoxylated.

All tests are fully reliable and negative, therefore there is no indication of a mutagenic potential of the test item.

Short description of key information:
The genetic toxicity of the test substance was assessed in 2 in vitro and 1 in vivo studies conducted in compliance with the principles of Good Laboratory Practices:
- a gene mutation assay on Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 (OECD guideline 471)
- an in vivo chromosomal aberration test: micronucleus assay (OECD guideline 474)
- an in vitro gene mutation assay in mouse lymphoma L5178Y cells (OECD guideline 476)

In all three studies negative results were reported in the presence and absence of metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to the criteria laid down in EU regulation (EC) n° 1272/2008 (CLP) and the EU directive 67/548/EEC, the substance is not classified for genetic toxicity as all in vitro and in vivo mutagenicity assays are negative.