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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation/corrosion:
-rabbit (C12DMA), key: corrosive
-rabbit (C12DMA), key: irritating
-rabbit (C14DMA), key: irritating
-rabbit (C14DMA), key: irritating
-rabbit (C16DMA), key: corrosive
-rabbit (C16DMA), non-key: irritating
-rabbit (C16DMA), non-key: corrosive
-rabbit (C12-14DMA), key: corrosive
-rabbit (C12-14DMA), key: corrosive
-rabbit (C12-14DMA), key: corrosive
-in-vitro OECD431 (C12-14DMA): not corrosive
-rabbit (C12-18DMA), key: corrosive
-rabbit (C12-18DMA), key: corrosive
-rabbit (C12-18DMA), key: corrosive
-rabbit (C12-18DMA), key: corrosive
-rabbit (C12-18DMA), non-key: no severe damage
-rabbit (C12-18DMA), non-key: severe damage
-rabbit (C16-18DMA): corrosive
-rabbit (C16-18DMA): corrosive
-in-vitro OECD431 (C16-18DMA), non-key: non-corrosive
-rabbit (18DMA), key: irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There is no experimental data on skin/eye irritation/corrosion for N,N-dimethyl-C12-16-(even numbered)-alkyl-1-amines, lactates. The acute toxicity of the registration substance is derived from the available data of dimethyl alkylamines (DMAs) with comparable length of alkyl chain (source substances).

Clear skin corrosive effects was observed in in-vivo studies in rabbit with both C12DMA, C16DMA, C12 -14DMA, C12 -18DMA, and C16 -18DMA. Although in some in-vivo and in-vitro studies, only irritating or non-corrosive effects are indicated, DMA is considered to be corrosive to skin, based on the "worst case" scenario. Based on the available data the substance is classified as Category 1B for skin irritation/corrosion, according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

According to EU regulation 1907/2006, Annex VII, column 2, the study regarding eye irritation needs not to be conducted since the substance is classified as corrosive to the skin.

The analogue approach using dimethyl alkylamines (DMAs) with comparable length of alkyl chain as source chemicals is justified:

The target chemical Amines, C12-16-alkyldimethyl, lactates is an ionic compound that results from the neutralization reaction of the compounds of lactic acid and C12-16-DMA. In aqueous solution or in a biological fluid, it could be dissociate as lactic acid and C12-16-DMA. Therefore, the toxicity toxicological profile of the target chemical should be comparable to that of C12-16-DMA and lactic acid. Lactic acid is a natural, functional metabolite in mammals, and serves as mammalian fuel. From previous investigations, it is concluded that lactic acid does not present a hazard for the human health based on its low hazard profile. Based on the basic concept of “chain length category”, the use of toxicity data of other dimethyl alkylamines with comparable length of alkyl chain for read-across purpose to C12-16-DMA and the target chemical is justified. The dissociated product of the target chemical – C12-16-DMA and the source chemicals of C12-DMA, C14-DMA, C16-DMA, C18-DMA, C12-14-DMA, C12-16-DMA, C12-18-DMA and C16-18-DMA belong to the homologues series of fatty amines and form a “chain length category”, where there is an incremental increase in the number of CH2 units. Therefore, it can be reasonably assumed that C12-16-DMA and other dimethyl alkylamines (C12-DMA, C14-DMA, C16-DMA, C18-DMA, C12-14-DMA, C12-16-DMA, C12-18-DMA and C16-18-DMA) share the same toxic mode of action.

The major available physic-chemical properties of target and source chemicals are in a comparable range and support hypothesis that the source and the target chemicals behave similarly or as a function of carbon chain length.

All the chemicals are assessed using the rule based expert system DEREK Nexus based on their chemical structures. The assessment results are identical for the target chemical and source chemicals: all the chemicals are predicted as negative for mutagenicity in bacteria. No toxicity potential or structure alert is identified.

With regard to the endpoint of skin irritation/corrosion, corrosive effect was identified for the source chemicals of C12-DMA, C16-DMA, C12-14-DMA, C12-18-DMA and C16-18-DMA. The target chemical is considered as corrosive to skin (Cat 1B) based on the analogue approach. For this endpoint, the analogue approach is also justified considering the “worst case” scenario.

Based on these similarities in structural, functional and metabolic behavior of DMAs and DMA lactates, it is therefore reasonable and scientifically justified to use analogue DMAs as source molecules to inform endpoint related data gaps for the target molecule under discussion.

 


Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Based on the available data the substance is classified as Category 1B for skin irritation/corrosion, according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).