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EC number: 944-209-3
CAS number: -
the assessment of the genotoxic potential of Amides,
C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] an
Ames test (tester strains: Salmonella
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.
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.
test substance Amides,
C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] was
tested for mutagenic activity in the bacterial tester strains Salmonella
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.
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.
adopted OECD TG 471 (1997) requires the use of E.
strains or Salmonella
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.
strains or Salmonella
102 is considered as sufficient to evaluate the mutagenic activity of
the test substance in this bacterial test system.
fully compliant Ames test with the closely related source substance Amides,
C8-18 even numbered, N-[3-(dimethylamino)propyl] supports
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.
strain WP2 uvrA of E.
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.
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.
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)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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