Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Based on available data on genotoxicity in vitro of three read-across source substances it can be concluded, that the test item has no potential to either be mutagenic or clastogenic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

Based on available data on genotoxicity in vivo of one read-across source substance it can be concluded, that the test item has no potential to either be genotoxic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

No experimental data on genotoxicity in vitro nor in vivo is available for the test item. However, experimental data for three source substances is available and a read-across approach is applied. Please refer to read-across justification document attached in IUCLID Section 13. Furthermore, only key studies of the source substances are taken into account. For further supporting information please refer to respective dossier of each source substance.

Source substance 1 (CAS 121617 -08 -1)

 

Reverse gene mutation in bacteria

In a reverse gene mutation assay in bacteria, strains TA98, TA100, TA1535, TA1537 and TA1538 of S. typhimurium were exposed to Benzenesulfonic acid, C10-13-alkyl derivs., compds. with triethanolamine (CAS no. 68411-31-4) at concentrations of 0, 8.4, 43, 217, 1090, and 5430 µg/plate in the presence and absence of mammalian metabolic activation according to the direct plate incorporation method and 0, 68, 136, 272, 543, and 1090 µg/plate in the presence and absence of mammalian metabolic activation according to the preincubation method.

The test substance was tested up to cytotoxic concentrations. The positive control induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background. 2- Benzenesulfonic acid, C10-13-alkyl derivs., compds. With triethanolamine (CAS no. 68411-31-4) was judged to have no reverse mutagenic potential under the conditions tested.

 

 

Source substance 2 (CAS 68411 -30 -3)

 

Reverse gene mutation in bacteria

A bacterial mutagenicity study (Ames test) was conducted on LAS and was found to be negative for mutagenicity.

 

Gene mutation in mammalian cells in vitro

This study examined the potential of the test substance to cause mutations in mammalian cells. Chinese Hamster Ovary (CHO) cells were exposed to concentrations of 0, 0.6, 1, 1.8, 3, and 6 µg/mL without S9, and 0, 6, 10, 18, 30, and 60 µg/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. Preliminary tests show the test substance was cytogenic at concentrations of 50 µg/mL or greater with metabolic activation, and 100 µg/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.

 

Chromosome aberration in vitro

This study examined the potential of the test substance to cause chromosomal aberrations in mammalian cells. Chinese hamster ovary cells were exposed to concentrations of 0.32 to 78 µg/mL with S9, and 1.25 to 156 µg/mL without S9. Methyl methanesuflphonate and cyclophosphamide were used as positive controls. No biologically significant results were seen in treated cultures in the absence of metabolic activation. Positive responses were seen at cytotoxic concentrations in the presence of S9. Concentrations below the level of cytotoxicty with S9 did not show positive results. The test substance is not clastogenic in the absence of metabolic activation, or with metabolic activation below cytotoxic concentrations. These results indicate that LAS induces chromosomal abberations at cytotoxic concentrations. However, this effect can be considered as secondary due to cytotoxicity.

 

 

Source substance 3 (CAS 111 -42 -2)

  

In vitro studies

DEA was tested for mutagenicity in the Ames test with and without metabolic activation. No mutagenic effect was observed in the Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 tested in the concentration range from 33 - 3333 µg/plate.

No mutagenic effect was reported in other investigations using Salmonella typhimurium or Escherichia coli strains and concentrations from 125 – 4000 µg/plate (Dean et al., 1985).

No clastogenic potential of DEA was noted in a cytogenetic study comparable to OECD TG 473 in Chinese Hamster Ovary (CHO) cells in the absence (101, 505, 2010 µg/mL) and presence (303, 1010, 3010 µg/mL) of metabolic activation (Loveday et al., 1989).

 

A chromosome damaging potential was also not noted in cultured rat liver epithelium-like RL1and RL4 cells at concentrations ranging from 0.125 - 0.5 of GI50 (50% growth inhibition) without metabolic activation (Dean et al., 1985).

 

DEA induced no sister chromatid exchanges in Chinese hamster ovary cells (similar to OECD TG 479) at concentrations from 150 – 1500 µg/ml with and without metabolic activation (Loveday et al., 1989).

 

A mouse lymphoma test comparable to OECD TG 476 carried out in the L5178 Y cell line with concentrations of 0, 25, 50, 100, 200, 300, 400, 600 µg/ml without and with S-9 mix showed no genotoxic potential up to the highest/cytotoxic concentration (NTP, 1992, 1999).

 

Mouse micronucleus in vivo

DEA was investigated for its clastogenic/genotoxic potential in vivo in a mouse micronucleus test in the peripheral blood. Male and female B6C3F1 mice were administered DEA in 95% ethanol once per working day to the uncovered skin at concentrations of 0, 37.5, 75, 150, 300, and 600 mg/ml (corresponding to 0, 80, 160, 320, 630, or 1250 mg/kg bw/day) for 13 weeks (65 applications) using a protocol equivalent or similar to OECD guideline 474. DEA treatment led to local and systemic signs of toxicity down to the lowest dose level. No induction of micronuclei was noted at any dose level.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data on three read-across substances are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. None of the three source substances showed a genotoxic potential. Therefore, there is no indication for the test item to be mutagenic or clastogenic. As a result the substance is not considered to be classified as genotoxic under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.