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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
For details on endpoint-specific justification, please see read-across justification document (category approach) in the linked category of dimethylalkylamines.

Data source

Materials and methods

Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, C16-18-alkyldimethyl
EC Number:
269-915-2
EC Name:
Amines, C16-18-alkyldimethyl
Cas Number:
68390-97-6
Molecular formula:
R-N(Me)2, whereas R= C16-18-alkyl (even numbered, unbranched, saturated)
IUPAC Name:
N,N-dimethyl-C16-18-(even numbered)-alkyl-1-amines

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
in the highest dose group: motor activity decreased, diarrhea, palpebral fissure narrow, movements uncoordinated, stupor, tonic convulsion, and prone position
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid

Any other information on results incl. tables

Results presented above were obtained with the source substance C12-14 DMA.

Applicant's summary and conclusion

Executive summary:

The study used as source investigated in vivo cytogenicity of C12-14 DMA. The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in the linked category of dimethylalkylamines.