Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Genetic toxicity in vitro: Bacterial reverse mutation assay: Key study: Read-across from experimental data on the analogue CAS No. 68155-09-9. Test according to OECD guideline 471 and EU guideline B14. GLP study.

The substance was considered to be non-mutagenic.

 

Genetic toxicity in vitro: Chromosomal aberrations in mammalian cells: Key study: Read-across from experimental data on the analogue CAS No. 68155-09-9. Test according to OECD guideline 473 and EU guideline B.10. GLP study.

The substance was shown to be non-clastogenic to human lymphocytes in vitro.

The analogue CAS No. 68155-09-9 which shares the same functional groups with the substance Amides, C12-C14 (even numbered), N-[3-(dimethylamino) propyl], N´-oxides, also has comparable values for the relevant molecular properties.

 

Cocamidopropylamine Oxide (CAS 68155-09-9) where R=C8-C18, is a tertiary amine oxide where RCO- represents the fatty acids from coconut oil. Coconut oil contains predominantly medium chain triglycerides with roughly 92% saturated fatty acids, 6% monounsaturated fatty acids, and 2% polyunsaturated fatty acids. Of the saturated fatty acids, coconut oil is primarily 44.6% lauric acid, 16.8% myristic acid, 8.2% palmitic acid, 8% caprylic acid, and other seven different saturated fatty acids in small amount. Its only monounsaturated fatty acid is oleic acid while its only polyunsaturated fatty acid is linoleic acid.

 

Therefore, the source chemical and the target chemical share the following functional groups:

a.- N-Oxide functionality

b.- Amide group

 

For the source substance, in the chemical structure, the R is substituted by C8-C18 and for the target substance the R is substituted by C12-C14.

 

Genetic toxicity in vitro: Gene mutation in mammalian cells: Key study: Read-across from experimental data on the analogue Amides, C12 -C18 (even numbered), N-[3 -(dimethylamino)propyl], N´-oxides. Test according to OECD guideline 476 and EU guideline B.17. GLP study.

The substance did not induce any toxicologically significant increases in the mutant frequency at the TK +/- locus in L5178Y cells and is therefore considered to be non-mutagenic.

The analogue Amides, C12-C18 (even numbered), N-[3-(dimethylamino) propyl], N´-oxides which shares the same functional groups with the substance Amides, C12-C14 (even numbered), N-[3-(dimethylamino) propyl], N´-oxides, also has comparable values for the relevant molecular properties.

 

Amides, C12-C18 (even numbered), N-[3-(dimethylamino) propyl], N´-oxides where Alkyl chain=C8-C18,is a tertiary amine oxide where RCO- represents the fatty acids.The chemical contains the following carbon chain distribution:

 

C8

<10 %

C10

<10 %

C12

40-65 %

C14

10-26 %

C16

6-14 %

C18

2-24 %

 

Therefore, the source chemical and the target chemical shares the following functional groups:

a.- N-Oxide functionality

b.- Amide group

 

For the source substance, in the chemical structure, the RCO- is substituted by C8-C18 (predominantly C12 and C14, about 60-70% of the total) and for the target substance the RCO- is substituted by C12-C14.


Justification for selection of genetic toxicity endpoint
No study was selected, since all in vitro studies were negative.

Short description of key information:
Genetic toxicity in vitro: Bacterial reverse mutation assay: Key study: Read-across from experimental data on the analogue CAS No. 68155-09-9. Test according to OECD guideline 471 and EU guideline B14. GLP study. The substance was considered to be non-mutagenic.
Genetic toxicity in vitro: Chromosomal aberrations in mammalian cells: Key study: Read-across from experimental data on the analogue CAS No. 68155-09-9. Test according to OECD guideline 473 and EU guideline B.10. GLP study. The substance was shown to be non-clastogenic to human lymphocytes in vitro.
Genetic toxicity in vitro: Gene mutation in mammalian cells: Key study: Read-across from experimental data on the analogue Amides, C12-C18 (even numbered), N-[3-(dimethylamino) propyl], N´-oxides . Test according to OECD guideline 476 and EU guideline B.17. GLP study. The substance did not induce any toxicologically significant increases in the mutant frequency at the TK +/- locus in L5178Y cells and is therefore considered to be non-mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available information on genetic toxicity in vitro, the substance is considered to be negative and therefore, the substance is not classified.