Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

After single oral application of 0.5, 5.3 or 51 mg sec-alkane sulfonate-sodium salt SAS - 14C via gavage to 3 groups of 6 male rats per group, blood levels reached a maximum about 2 to 6 hours after administration. Elimination from the blood was biphasic with biological half-lives of 11 and 65 hours. Up to 17 % of the administered radioactivity was exhaled as CO2; approximately 30 % was excreted via urine and about 45 % with faeces. In total more than 90 % of the applied radioactivity was excreted within the first 24 hours after application. Indications of bioaccumulation were not revealed as demonstrated by very low residual radioactivity (< 1 ppm) in organs after 7 days.

Dermal application of about 0.25 mg sec-alkane sulfonate-sodium salt SAS - 14C onto approximately 6 cm2 shaved back skin for 1.25 hours revealed maxima in blood levels about 2 to 6 hours p.a. Elimination half-life was in average about 41 hours (air approximately 15 %, urine approximately 18 %, faeces approximately 31 %). Most radioactivity was found in the bandage (approximately 35 %) whereas only about 2.2 % was detected in the treated skin 7 days p.a. The available data point to a low skin penetration potential of sec-alkane sulfonate-sodium salts SAS.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - dermal (%):
1

Additional information

Single oral or dermal administration of radiolabelled sec-alkane sulfonate-sodium salts SAS-C14 revealed that the kinetic behaviour is independent of the administered dose. After oral as well as after dermal exposure, highest blood levels occurred approximately 2 to 6 hours after application. Elimination was biphasic with half-lifes of about 11 and 65 hours after oral and approximately 41 hours after dermal exposure. In both cases more than 90% of the applied doses were eliminated within 24 hours. The available data point to a low skin penetration potential of sec-alkane sulfonates SAS. Indications of a bioaccumulative behaviour were not found. Residuals of less than 1 ppm of the administered dose were found in organs and tissues 7 days p.a.

Discussion on bioaccumulation potential result:

Experimental studies using radiolabelled sec-alkane sulfonate-sodium salts SAS have not revealed indications of a significant bioaccumulation potential.

Discussion on absorption rate:

Experimental studies using radiolabelled test material have not revealed indications that sec-alkane sulfonate-sodium salts SAS is significantly absorbed through skin after dermal treatment. This result is in line with data for ionic substances where percutaneous absorption is considered to be very low. A dermal penetration rate of approximately 1% for sec-alkane sulfonate-sodium salts SAS as for anionic substances in general is therefore considered scientifically justified.