Poly(oxy-1,2-ethanediyl), .alpha.-[3-[(carboxymethyl)methylamino]-2-hydroxypropyl]-.omega.-(4-nonylphenoxy)-, sodium salt (1:1)

Endpoint summary

Additional information

Nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5) was tested for genetic toxicity in three in vitro tests. All the three tests showed no indications on genetic toxicity.

The bacterial reverse mutation assay (Ames test), reliability rating 1, showed thatnonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5)did not cause any substantial increase in revertant colony numbers of any of the five tested strains at any dose level, either in the presence or absence of metabolic activation (S9 mix). No evidence of mutagenic potential was seen in this study.

 

In the in vitrotest on mammalian cell gene mutation in the L5178Y TK +/- mouse lymphoma assay, with reliability rating 1,nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5)was not mutagenic in presence of metabolic activation by S9 mix or after long time exposure without metabolic activation by S9 mix.

It can be stated that in the in vitro chromosome aberration test in human lymphocytes and under the experimental conditions reported, the test itemnonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5)did not induce structural and/or numerical chromosomal damage in human lymphocytes.

Justification for selection of genetic toxicity endpoint
No specific study has been selected as the conclusion that nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5) is not genotoxic/mutagenic is based on all the three negative in vitro studies available; the Ames test (OECD 471), the chromosome aberration test (OECD 473), and the mouse lymphoma study (OECD 476).

Short description of key information:
Nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5) has been tested in three in vitro genotoxicty studies.

The first study available is the bacterial reverse mutation assay (Ames test), performed under GLP and with reliability rating 1. In the study the bacteria strains TA98, TA100, TA1535 and TA1537 of S. typhimurium and the E. coli RHW WP2 uvrA strain were exposed at different concentrations up to 5000 µg/plate in the presence and absence of S9. No increase in revertant colony numbers of any of the five tester strains was observed following the treatment at any dose level, neither in the presence nor absence of S9 mix. There was no tendency of higher mutation rates with increasing concentrations in the range of biological relevance.

The second available genetic toxicity study is the in vitro mammalian cell gene mutation test in mouse lymphoma L5178Y cells, (OECD Guideline 476), which is GLP compliant and has reliability rating 1. The assay was performed in two independent experiments, using two parallel cultures each. No biologically relevant increase of mutants was found after treatment with the test item (with and without S9 mix). Colony sizing showed no clastogenic effects induced by the test item under the experimental conditions.

The third genetic toxicity study is the in vitro chromosome aberration test in human lymphocytes. In Experiment I and IIB in the absence of S9 mix, clear cytotoxicity was observed at the highest evaluated concentrations. In Exp I in the presence of S9 mix and in Exp IIA in the absence and presence of S9 mix, concentrations showing clear cytotoxicity were not evaluable for cytogenetic damage. Neither a statistically significant nor a biologically relevant increase in the number of cells carrying structural chromosomal aberrations was observed after treatment with the test item. No evidence of an increase in polyploid metaphases was noticed after treatment with the test item as compared to the control cultures.

Endpoint Conclusion: No adverse effect observed (negative)