Phenol, sulfonated

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test negative.

Micronucleus assay negative.

In vitro mammalian cell gene mutation test using the Hprt and xprt genes according to OECD 476: in progress

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Ames test: This study was performed to evaluate the mutagenic activity of Phenol sulphonated (EC: 277-962-5; CAS: 74665-14-8) sold under the commercial name SELLATAN P using the bacterial reverse mutation test on five histidine deficient mutant tester strains of Salmonella typhimurium (i.e., TA1537, TA1535, TA98, TA100, and TA102).
The test item was tested in two independent experiments in the absence and presence of metabolic activation.
Bacterial cultures were exposed to the test item at 8 concentration levels (two plates/concentration) ranging from 0.0015 to 5 μL/plate in the initial toxicity-mutation test, using the plate incorporation method.
Normal bacterial background lawn was observed up to the concentration of 5 μL/plate, in all tester strains (TA1537, TA1535, TA98, TA100, and TA102) in the absence and presence of the metabolic activation system (5% v/v S9 mix).
No increase in the number of revertant colonies (no mutagenic effect) was observed in the absence and presence of the metabolic activation system (5% v/v S9 mix) in any tester strain. To confirm the negative results obtained in the initial toxicity mutation test, the confirmatory mutation test was conducted, using the plate incorporation method with an increased S9 concentration, i.e., 10% v/v S9 mix and concentration spacing modification.
Bacterial cultures were exposed to Phenol sulphonated (EC: 277-962-5; CAS: 74665-14-8) sold under the commercial name SELLATAN P at 6 concentration levels (three plates/concentration) ranging from 0.15625
to 5 μL/plate for tester strains TA1537, TA1535, TA98, TA100, and TA102 in the absence and presence (10 % v/v S9 mix) of the metabolic activation. The revertant colonies were scored after 48 hours of incubation at 37 ± 1 °C.
The test item did not induce any significant increase in the number of revertants, in trials with and without S9 mix, in any tester strain. Values for the negative control were within the historical control ranges of the laboratory. Positive controls showed an increase in the number of revertant colonies, demonstrating the efficiency of the test system. All criteria for a valid study were met. Based on the results of this study, under specified experimental conditions, Phenol sulphonated (EC: 277-962-5; CAS: 74665-14-8) sold under the commercial name SELLATAN P is concluded to be non-mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium.

Micronucleus assay: The evaluation of the clastogenic and anugenic damaging potential of Phenol Sulphonated (EC:277-962-5; CAS:74665-14-8) sold under the commercial name SELLATAN P was assessed in an in vitro mammalian cell micronucleus test, using cultured human peripheral blood lymphocytes. Phenol Sulphonated (EC:277-962-5; CAS:74665-14-8) sold under the commercial name SELLATAN P was tested in two independent experiments, in the absence or presence of metabolic activation (2% v/v S9 mix), at selected concentrations based on results of a cytotoxicity test. In the main study, human peripheral blood lymphocyte cultures were exposed to the test item at 6 concentrations from 156.25 µg/mL to 5000 µg/mL (two cultures/dose level) in culture medium, in the absence or presence of a metabolic activation system. The main study was conducted in two phases with lymphocytes exposed for 4 hours (with and without metabolic activation) as Phase I, and for 24 hours exposure (without S9) as Phase II. Following the consideration of the replicative index data, three concentrations of the test item were selected for micronucleus frequency analysis. Phenol Sulphonated (EC:277-962-5; CAS:74665-14-8) sold under the commercial name SELLATAN P did not induce either a statistically significant or biologically relevant increase in the number of binucleated cells with micronuclei, in the absence or presence of the metabolic activation, in either independently conducted experiment. The positive controls (cyclophosphamide and vinblastine) induced a statistically significant increase in the number and frequency of micronucleated binucleate cells and all criteria for a valid study were met. From results of this study, it is concluded that Phenol Sulphonated (EC:277-962-5;CAS:74665-14-8) sold under the commercial name SELLATAN P did not induce micronuclei in isolated cultured human peripheral blood lymphocytes, when tested up to the concentration of 5000 µg/mL both in the absence and in the presence of metabolic activation (2% v/v S9 mix), under the described experimental conditions.

The In vitro mammalian cell gene mutation test using the Hprt and xprt genes according to OECD 476 in progress at the moment of the submission of the dossier. In the corresponding endpoint, the study plan conditions are described.

 

 

 

Justification for classification or non-classification

The test item is not classified for genetic toxicity according to the CLP Regulation (EC.n.1272/2008). For justification see the results of available studies.