Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., calcium salts

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Remarks:

expert statement

Type of information:

other: assessment of available information

Data source

Reference

Reference Type:

other: expert statement

Title:

Unnamed

Year:

2018

Materials and methods

Test material

Test material information

Test material form:

solid

Applicant's summary and conclusion

Executive summary:

No specific study was performed on the absorption, distribution, metabolism, excretion (ADME) of this substance (WS400347), but data are currently available fromin vivoandin vitrotoxicology studies.

 

The substance, WS400347, is a UVCB substance, calcium salts ofbenzenesulfonic acid, 4-sec-C_10-13-alkyl derivs. The substance has low water solubility (172 mg/l) but it dissociates in water to a sufficient extent to exhibit surface activity. Themolecular weight of the acids amounts to approx. 340 Da (C12 alkyl-derivative). Based on the fact that the substance has surface activity there is no true value for lipophilicity.

It is expected (and was confirmed in bridging studies) that the salt dissociates in aqueous environments. Accordingly, exposure of man and the environment will be to calcium andbenzenesulfonic acid, 4-sec-C_10-13-alkyl derivs.

Calcium is a major element in our daily diet und thus of low toxicity. Therefore, any adverse effects of WS400347 will be based on toxic properties ofbenzenesulfonic acid, 4-sec-C_10-13-alkyl derivs.

 

After oral exposure to WS400347 absorption ofbenzenesulfonic acid, 4-sec-C_10-13-alkyl derivsand systemic distribution is to be expected based on the low molecular weight. In repeat dose feeding studies performed with sodium salts of different linear alkylbenzenesulfonic acids,that were used as read-across source substance, some effects in liver and kidneys were observed at high doses indicating systemic distribution. In acute oral toxicity studies performed in rats with the read-across source substances the LD50 ranged from doses of approx. 1000 to 1600 mg/kg body weight.

Systemic availability of WS400347 after dermal application is expected to be low based on absence of acute dermal toxicity in a study performed with a read-across source substance. However, based on surface activity of WS400347 and based on skin irritation observed with sodium salts of linear alkylbenzenesulfonic acids skin penetration may be enhanced after irritation.

Availability of WS400347 under a vapour state can be excluded, because of its very low vapour pressure (10^-17 Pa, calculated).

There is no information on metabolism and excretion of WS400347.

 

Based on the available information the bioaccumulation of WS400347 cannot be assessed.