Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
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 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.

Migrated from Short description of key information:

There is one delayed dermal sensitisation study available (OECD406), carried out on the analogue Trimethylolpropane Tripelargonate,  which indicates that it does not induce and elicit delayed dermal sensitisation in guinea pigs.

Justification for selection of skin sensitisation endpoint:

This study is a well documented, recent GLP study according to international guidelines carried out on the analogue TMP Pelargonate.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation

As no sensitisation response was observed during the study (OECD406), the substance is not to be classified for skin sensitisation effects according to the criteria described in Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) or Directive 67/548/EEC (Dangerous Substances Directive).