1-Octadecanol, phosphate, potassium salt

Endpoint summary

Additional information

Ames Test

In a reverse gene mutation assay in bacteria according to OECD guideline 471, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535 of S. typhimurium were exposed to 1-Octadecanol, phosphate, potassium salt (Silastol H 200 TS), at concentrations up to 5000 µg/plate in the presence and absence of mammalian metabolic activation. No signs of toxicity towards the bacteria could be observed. None of the concentrations caused a significant increase in the number of revertant colonies in the tested strains. 1-Octadecanol, phosphate, potassium salt didn't show any mutagenic effects in both experiments.

 

Mammalian Cell Gene Mutation Test

An in vitro mammalian cell assay according to OECD Guideline 476 was performed in V79, (HPRT locus), to test the potential of the read-across substance Phosphoric acid, dodecyl ester, potassium salt (Afilan V5756) to cause gene mutation and/or chromosome damage. Cells were exposed to the test substance in cell culture medium (MEM + 0% FBS 4h treatment; MEM + 10% FBS 20h treatment) up to cytotoxic concentrations, with and without metabolic activation.There was no evidence of a concentration related positive response of induced mutant colonies over background.

The same study was conducted with the read-across substance hexadecyl dihydrogen phosphate. As well, in this study there was no evidence of a concentration related positive response of induced mutant colonies over background.

 

Chromosomal Aberration Test

The potential of the read-across substance Phosphoric acid, dodecyl ester, potassium salt (Afilan V5756) to induce structural chromosome aberrations in Chinese hamster V79 cells, was investigated in an in vitro chromosome aberration assay, according to OECD guideline 479.

The chromosomes were prepared 20 h after start of treatment with the test item. The treatment interval was 4 h with and without metabolic activation in experiment I. In experiment II, the treatment interval was 4 h with and 20 h without metabolic activation.

In both experiments, no biologically relevant increase of the aberration rates was noted after treatment with the test item with and without metabolic activation. The aberration rates of all dose groups treated with the test item were within the historical control data of the negative control.

In the experiments I and II with and without metabolic activation no biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item as compared to the controls.

In conclusion, it can be stated that during the described in vitro chromosome aberration test and under the experimental conditions reported, the test item Afilan V5756 did not induce structural chromosomal aberrations in the V79 Chinese hamster cell line.

Therefore, Phosphoric acid, dodecyl ester, potassium salt (Afilan V5756) is considered to be non-clastogenic in this chromosome aberration test.

Conclusion

All in vitro and in vivo tests in genetic toxicity showed negative results. There is no reason to believe that the negative results would not be relevant to humans. No further testing is required.

Justification for read-across:

The read-across approach is appropriate due to similar composition of source substance and registered substance. From the available data it can be concluded that the potential of genic toxicity of substances with different alkyl moieties (C12 and C16) is comparable.

Data for source substance are conducted on alkyl phosphoric esters, whereas the substance to be registered is neutralized with potassium hydroxide. As both substances dissociates in aqueous media, there are no reasons to assume a different profile for this endpoint.

Justification for selection of genetic toxicity endpoint
Reliable data are available from the full in-vitro test set required under REACH regulation.

Short description of key information:
Negative data are available from a gene mutation assay in bacteria with 1-Octadecanol, phosphate, potassium salt. As well negative data were obtained from a chromosomal aberration test and two mammalian cell gene mutation assays with the read-across substances.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification is required based on negative in-vitro data set.