Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
negative with and without metabolic activation; Ames test (OECD TG 471; GLP; RL2 ): tester strains S. typhimurium TA 1535, TA 100, TA 1537, TA 1538 and TA 98
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

For the assessment of the genotoxic potential of Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] an Ames test (tester strains: Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 1538 and TA 98) with the substance itself is available as well as an Ames test (strains TA 1535, TA 1537, TA 98 and TA 100 of S. typhimurium and strain WP2 uvrA of E. coli) with the closely related source substance Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]. A justification for read-across is given in IUCLID section 13.

The test substance Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] was tested for mutagenic activity in the bacterial tester strains Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 1538 and TA 98. The test was conducted on agar plates in the absence or presence of postmitrochondrial supernatant fluids from the liver of male rats treated with Aroclor 1254 (S-9 mix). Suspensions of the test compound were freshly made up with Tween 80 in water just before use. The following concentrations were tested: 0.8, 4, 8, 20, 40, 100, 200, 500, 1000 and 5000 µg test item per plate.

Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] did not induce reverse mutations in the presence and absence of S-9 mix in the tester strains TA 1535, TA 100, TA 1537, TA 1538 and TA 98. The test item did not show mutagenic activity in vitro.

The adopted OECD TG 471 (1997) requires the use of E. coli WP2 strains or Salmonella typhimurium TA 102 to detect certain oxidizing mutagens, cross-linking agents and hydrazines. However, the test substance is not a highly reactive agent and is therefore not expected to be a cross-linking agent, has no oxidizing properties and is no hydrazine. Thus, a test according to EU Method B.13/14 (Version Commission Directive 92/69/EEC without E. coli WP2 strains or Salmonella typhimurium TA 102 is considered as sufficient to evaluate the mutagenic activity of the test substance in this bacterial test system.

A fully compliant Ames test with the closely related source substance Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl] supports this:

In a reverse gene mutation assay in bacteria according to OECD guideline 471, 21 July 1997 and EU Method B.13/14, 30 May 2008, strains TA 1535, TA 1537, TA 98 and TA 100 of S. typhimurium and strain WP2 uvrA of E. coli were exposed to Amides, C6 -C18, N-[3 -(dimethylamino)propyl] (a.i. 98.4%). Three independent experiments were performed at concentrations of 0 (control), 62, 185, 556, 1667 and 5000 µg/plate in the first experiment; 0 (control), 1, 4, 11, 33 and 100 µg/plate in the second experiment; 0 (control), 1, 2, 6, 17 and 30 µg/plate in the third experiment all in the presence and in the absence of mammalian activation.

No evidence of biologically significant mutagenic activity of the test item was found in the presence and in the absence of metabolic activation, up to and including the limit concentration of 5000 µg/plate. Biologically significant bacteriotoxic effects were observed at concentrations >33 µg/plate. Precipitation of the test substance in the top agar mixture was observed from the concentration 62 µg/plate upwards. The positive controls induced the appropriate responses in the corresponding strain and activity of metabolizing system was confirmed. There was no evidence of induced mutant colonies over background.


Justification for selection of genetic toxicity endpoint
guideline study, GLP

Justification for classification or non-classification

Based on relevant, reliable and adequate data Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] does not need to be classified for genotoxicity according to regulation (EC) 1272/2008.