Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

No studies on the EC substance [940-223-9] itself are available. Limited information fromstructurally closely related compounds indicates that oral absorption can be assumed. Thus, a value of 100% for oral uptake is considered. Dermal absorption is considered to be negligible and a value of 10% is taken as conservative assumption. Independent of the exposure route, rapid elimination can be assumed and a bioaccumulation potential can most probably be excluded.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - dermal (%):
10

Additional information

Data on toxicokinetics of the EC substance [940-223-9] itself are not available. Limited information from literature on the structurally closely related sodium lauroyl sarcosinate indicates that this material is absorbed from the gastrointestinal tract. After oral administration of radiolabelled test material about 90% of the applied dose was excreted in urine within the first 24 hours which indicates also rapid elimination (Lanigan, R.S. 2001). With regard to sodium cocoyl glycinate, various studies have shown, that N-cocoyl glycinate is metabolized in vivo initially via enzymatic hydrolysis mediated by hydrolases including aminoacylases (EC 3.5.1.14) to the metabolites glycine and lauric acid and/or respective fatty acids (Shintani et al., 1984; Herga et al., 2005; Koreishi et al. 2009).

Like for oral administration, experimental data on in vivo dermal penetration of the registered substance are also not available. Limited information from literature on the structurally closely related sodium lauroyl sarcosinate indicates that this compound has low dermal penetration potential. In an in vitro study dorsal skin from Wistar rats was placed in a Franz diffusion cell and the receptor chamber was filled with PBS (phosphate-buffered saline). The amount of transdermal penetration from 500 mg lauroyl sarcosine in an ointment was approximately 1660 microgram over 24 hours corresponding to less than 1% of the applied does (Lanigan, R.S. 2001). Supported is this view of low dermal penetration by observations after application of a sodium lauroyl sarcosinate containing paste to teeth and oral mucosa which indicated that this compound is not absorbed by tissues of the mouth (lanigan, R.S. 2001). As a conclusion from the available data, acyl sarcosinates are considered safe when topical used in leave-on cosmetic products at concentrations up to 5%. A bioaccumulation potential is most probably be excluded. Due to close structural similarities, the registered substance is likely to have similar absorption and elimination kinetics to sarcosinates. However, to increase the confidence in the read-across a value of 100% for oral uptake is considered for risk assessment purposes and by applying an additional factor 2 a value of 10% is taken as conservative assumption for dermal penetration.