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Description of key information

For the endpoint skin irritation/corrosion there is an in vitro study available (Andres, 2013) indicative of the fact that the analogue TMP Pelargonate is a non-corrosive substance. In addition there is an acute dermal toxicity study (Salvador, 2014) from which there were no indications of skin irritating effects relatively again to the analogue TMP pelargonate. Based on these studies the substance TMP C5-9 can be regarded as non-irritating to the skin.

With regard to the eye irritation effects, there are also two studies available. Both the in vitro (Andres, 2013) and the in vivo study (Salvador, 2014) indicate that the test item, Trimethylolpropane Tripelargonate, has no eye irritating properties. Then also its analogue TMP C5-9 is not irritant for eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

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 skin irritation / corrosion endpoint:

This in vitro skin corrosion study by Andres (2013) is a well documented, recent GLP study according to international guidelines. Moreoever, based on the acute dermal toxicity results reported in the study of Salvador (2014) (LD50 > 2000 mg/kg bw) on the analogue TMP Pelargonate, no skin irritating properties are expected for the substance TMP C5-9.

Justification for selection of eye irritation endpoint:

There are two studies available, one in vitro and one in vivo. The identified key study study is an in vivo eye irritation study in rabbits, which was performed according to GLP and international guidelines (Salvador, 2014).

Justification for classification or non-classification

Skin irritation:

As no skin irritating properties are expected based on the in vitro Human Skin Model Test following OECD guideline 431 results, and no skin irritation effects were seen in the acute dermal toxicity study, the substance is not to be classified according to the criteria described in EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of substance and mixtures (CLP) nor Directive 67/548/EEC (Dangerous Substances Directive).

Eye irritation

As no effects of eye irritation or eye damage are observed in any of the performed studies (OECD 437 and 405), the substance is not to be classified according to the criteria described in EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) nor Directive 67/548/EEC (Dangerous Substances Directive).