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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Oral:
-rat, LD50 (C12DMA): 1220 mg/kg (male)
-rat, LD50 (C12DMA): 1890 mg/kg (male); 1450 mg/kg (female)
-rat, LD50 (C14DMA): >1600 mg/kg (male); 1320 mg/kg (female)
-rat, LD50 (C14DMA): 2166 mg/kg (male/female)
-rat, LD50 (C16DMA): 1015 mg/kg (male/female)
-rat, LD50 (C16DMA): 2000 mg/kg (male); >2000 mg/kg (female)
-rat, LD50 (C12-14DMA): >2000 mg/kg (male); 1015 mg/kg (female)
-rat, LD50 (C12-18DMA): 1500 mg/kg (male); 1300 mg/kg (female)
-rat, LD50 (C12-18DMA): >2000 mg/kg (male/female)
-rat, LD50 (C12-18DMA): 1000-1250 mg/kg (male/female)
-rat, LD50 (C18DMA): 2116 mg/kg (male/female)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 000 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 study available

Additional information

There is no experimental data on acute toxicity for the registration substance 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).

No acute toxicity potential was derived some aucte oral studies in rats with C14DMA, C16DMA, C18DMA, C12-18DMA and C12 -14 DMA (LD50 > 2000 mg/kg). However, in other studies of C12DMA, C14DMA, C16DMA and C12 -18DMA there is data indicating the LD50 is in the range of 1000 -1890 mg/kg.

Considering all the information available, the LD50 of the registration substance is considered to be greater than 1000 mg/kg. Therefore, the registration substance is classified as Cat.4 for acute oral toxicity,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).

Justification for classification or non-classification

Based on the available data, the substance is classified as Cat.4 for acute oral toxicity,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).