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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Two recent GLP studies that were performed on the analogue TMP Pelargonate according to OECD guidelines are present for acute toxicity oral and acute toxicity dermal (Salvador, 2014 and 2014a). Both studies did not show any adverse effects up to a concentration of 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

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 polyesters 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 acute toxicity – oral endpoint

There is only one study available on the analogue TMP Pelargonate but this study is a well documented, and performed recent GLP study according to international guidelines.

Justification for selection of acute toxicity – inhalation endpoint

Data on toxicity via the oral and dermal route are available on the analogue TMP Pelargonate . Futhermore, the substance is a viscous oil and the inhalation route of exposure is not considered to be the most relevant one.

Justification for selection of acute toxicity – dermal endpoint

There is only one study available on the analogue TMP Pelargonate but this study is a well documented, and performed recent GLP study according to international guidelines.

Justification for classification or non-classification

Based on the acute toxicity results, showing LD50 values > 2000 mg/kg bw for oral and dermal administration,the substance should not be classified as acute toxic according to the criteria described in EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP)