Registration Dossier
Registration Dossier
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EC number: 451-900-9 | CAS number: 894406-76-9
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Two studies were carried out on toxicokinetics, metabolism and distribution using the structural analog Didecyldimethylammonium chloride (DDAC). In view of the chemical and structural similarities (the relevant chemical part of both, DDAC and DDACarbonate, under the conditions of this test is the common quaternary ammonium cation Didecyldimethylammonium+), it is considered that the data are adequate for DDACarbonate.
One study was carried out according to EPA OPP 85-1 (Metabolism and Pharmacokinetics). Sprague Dawley rats (5 male and 5 female per experiment) were dosed with radiolabelled test substance. In all of the experiments approximately 89 – 99 % of the recovered radioactivity was found in the feces and less than 2.5 % in the urine. Tissue residues of 14C were less than 1 % of the administered dose in all groups. DDAC appears to be metabolized in the gut of rats, apparently by microflora. Metabolism in females was greater than in males and lower doses were more extensively metabolized than higher doses in females. No tissue accumulation of the test substance was observed. Repeated dosing did not alter the uptake, distribution or metabolism of DDAC.
In addition a study on dermal absorption was carried out according to OECD draft guideline for the testing of chemicals (1999), OECD draft guidance for the conduct of skin absorption studies (1999) and COLIPA cosmetic ingredients: guidelines for percutaneous absorption/penetration (1995). 14C-DDAC was applied, in an aqueous formulation, to human skin samples using a flow through diffusion cell system. Less than 0.1 % of the applied 14C-DDAC dose penetrated human skin. 2.92 % of the applied dose was absorbed into the skin. 96.25 % was not absorbed. The cumulative flux value was 0.11 µg equiv/cm.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 2.5
- Absorption rate - dermal (%):
- 0.1
Additional information
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