Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Read-across justification

 From TMP Pelargonate CAS 127-57 -8

 ·Carbon number in Fatty Acids: C 9     

·Carbon number in Polyol: C6

·Total Carbons in Polyol Ester: C33     

·Molecular Weight:     554

 To Fatty Acids, C5 -9

 ·Carbon number in Fatty Acids: C5-9     

·Carbon number in Polyol: C6

·Total Carbons in Polyol Ester: C26 - C32   

·Molecular Weight: 400 - 540  

Both belong to the Trimethylolpropane (TMP) Esters as they have the trimethylolpropane group as a common structural part.

 

For both substances, it is valid to assume that when metabolism of these triesters takes place, this firstly leads to the generation of the corresponding fatty acids and of the polyol alcohol.

For substance “TMP Pelargonate" (CAS 127 -57 -8) this relates to trimethylolpropane and three C9 fatty chains.

For substance “TMP Fatty Acids, C5 -9” this also relates to trimethylolpropane and 3 C5-9 fatty chains.

As it is not expected that the acute toxicity is different between C5 and C9 fatty acid chains, read-across is considered justified.

Justification for selection of genetic toxicity endpoint

It has to be noted that all three genotox tests are of equal importance, as they assess different types of genotoxic response to a test chemical.

Short description of key information:

There are three K1 genotoxicity tests available. An Ames study (OECD 471) (Scarcella, 2013), an in vitro cytogenicity study in mammalian cells (OECD 487) (Giliutti, 2014) and an in vitro gene mutation study in mammalian cells (OECD 476) (Bisini, 2014) all carried out on the analogue TMP Pelargonate. None of the tests indicated adverse effects of this subtance.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

As no effects on Ames bacteria, human lymphocytes and observed micronuclei, the substance is not to be classified according to the criteria described in EU Regulation No. 12 72/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) or Directive 67/548/EEC (Dangerous Substances Directive).