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Description of key information

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
10
Absorption rate - dermal (%):
10
Absorption rate - inhalation (%):
20

Additional information

Experimental  in vivo  data on oral, inhalative and dermal absorption, distribution and excretion is not available for the target substance Undecylenamidopropyl Betaine.

According to theoretical considerations based on physicochemical properties a moderate to high dermal absorption is anticipated if the water solubility is between 100-10,000 mg/L. A molecular weight of less than 100 favours dermal uptake. Above 500 the molecule may be too large. For substances with log Kow values <0, poor lipophilicity will limit penetration into the stratum corneum and hence dermal absorption.

Although molecular weight (327.48 g/mol) and water solubility (3.1 g/L at 20°C) of the target substance Undecylenamidopropyl Betaine are in a range suggesting dermal absorption, the low log Kow of -1.38 as well as the ionic nature suggest that the substance is not likely to be sufficiently lipophilic to cross the stratum corneum, therefore dermal absorption is likely to be low.

 

Additionally,  in vivo  toxicokinetic data on metabolism and distribution are available for the oral and dermal route conducted with source substance C12 AAPB and for the dermal route conducted with the source substance Coco AAPB.

The fate of C12 AAPB in the rat was studied in an ADME study (ADME - absorption, distribution, metabolism, excretion) comparable to OECD Guideline 417.

Two differentially labelled samples were used: (N(lauroylaminopropyl)-N,N-dimethyl-N-carboxymethyl ammonium (inner) carboxylate) isotopically labelled with14C in the carboxymethyl ammonium moiety ([14C]TB) and N(lauroylaminopropyl)-N,N dimethyl-N-carboxymethyl ammonium (inner) carboxylate, isotopically labelled with14C in the 1 carbon of the lauroyl moiety ([1-14C]TB).

After gavage administration, C12 AAPB is poorly absorbed from the intestinal tract following administration in water at 30 mg/kg or 10 mg/kg bw, respectively. Within 48 hours, approximately 5% of the 14C dose was excreted in urine and < 2 % in expired air and < 2% remained in the carcass. The remainder was excreted in the faeces as unchanged parent material.

Whole body autoradiography confirmed that absorption from the gut was low and that the tissues showing detectable levels of 14C were those predominantly associated with urinary excretion (liver, kidney cortex, urinary bladder). The urine contained traces of parent and an unidentified polar metabolite. Although metabolism of absorbed material is extensive, the lauryl moiety is not extensively removed from the rest of the molecule judging by the relatively low amounts of 14CO2 produced.

Dermal application (approximately 20 mg/kg (approximately 0.3 mg/cm²)) of C12 AAPB 14C-labelled at the carboxymethyl ammonium or approximately 10 mg/kg (approximately 0.15 mg/cm²) of C12 AAPB 14C-labelled in the lauryl moiety in water) followed by 48 h occlusion gave similar results. After 48 hours, approximately 3.5-6% (females) and 2-3.5% (males) was absorbed. Urine was the major route of excretion for absorbed material with expired air and faeces being relatively minor routes.

 

Furthermore, dermal permeation and penetration of Coco AAPB was investigated using human skin in an in vitro study according to OECD guideline 428. Dermal absorption was not detectable: the mean absorbed dose of the test item, sum of the amounts found in the viable epidermis, dermis and receptor medium was 0%.

 

A similar low absorption via the oral, dermal and inhalative route is to be expected for the target substance Undecylenamidopropyl Betaine, based on close structural similarity to the source substances C12 AAPB and C8-18 and C18 unsatd. AAPB.