Benzenesulphonic acid, dimethyl-, mono C14-16 (even numbered) sec alkyl derivs.

Endpoint summary

Additional information

Benzenesulphonic acid, dimethyl-,mono C14-16-alkyl derivative (H250 sulphonic acid) is a UVCB. Based on structural and functional similarities, data on Benzenesulphonic acid, 4-C10-13-sec-alkyl derivatives (LABS; CAS no: 85536-14-7) being registered under REACH, LABS Na (CAS no: 68411-30-3) being registered under REACH and LAB (CAS no: 67774-74-7) being registered under REACH are suitable as supporting study in case where specific data on the substance is lacking.

No study on mutagenicity is available with the substance. Benzenesulphonic acid, 4-C10-13-sec-alkyl derivatives sodium salts (LABS Na, CAS No: 68411-30-3) was used to cover this endpoint as structural analogue substance.

S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 were treated with the LABS Na at five dose levels 8, 40, 200, 1000 and 5000 ug/plate both with and without the addition of S9-mix according to EU Method B.13/14. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method. During the pre-incubation test, signs of toxicity were noted at concentrations as low as 125 ug/plate. No precipitation of the product was observed at any concentration tested.

The study examined the potential of LABS Na, to cause mutations in mammalian cells according to OECD guideline 476. Chinese Hamster Ovary (CHO) cells were exposed to concentrations of 0, 0.6, 1, 1.8, 3, and 6 ug/mL without S9, and 0, 6, 10, 18, 30, and 60 ug/mL with S9. The cells were then examined for cytogenicity and mutation frequency. Ethyl methane sulfonate and 3-(20-)methylcholanthrene were used as positive control substances. The test substance was cytogenic at concentrations of 50 ug/ml or greater with metabolic activation, and 100 ug/mL or above without metabolic activation. There was no biologically significant increase in mutation frequency in the treated groups. The test substance is considered not mutagenic to CHO cells both in the presence and absence of S9.

A mammalian germ cell cytogenetic assay were designed to understand the genetoxicity profile of LABS Na. A group of 5 male mice was fed a diet containing 0.9% test substance for 9 months. At the end of this period, the animals were sacrificed, and the bone marrow cells examined for chromosome aberrations. No increase in chromosome aberrations was seen as compared to controls. The test substance is not clastogenic.

Short description of key information:
No study on mutagenic activity is available with the substance. Data from Benzenesulphonic acid, 4-C10-13-sec-alkyl derivatives, sodium salts (LABS Na, CAS No: 68411-30-3) was used to assess the mutagenic potential of the substance. Two in vitro and one in vivo genotoxicity studies from LABS Na were used to support to substance. H250 sulphonic acid is considered to be not mutagenic under the condition of genotoxicity tests.

Endpoint Conclusion:

Justification for classification or non-classification

According to in vitro and in vivo mutagenicity test results (Ames test, gene mutation test and germ cell cytogenocity- chromosomal aberration test) from structural analogue substance, the substance is considered to be not mutagenic and does not need to be classified for genotoxicity.