3,7,11,15-tetramethylhexadecane-1,2,3-triol

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The genotoxic potential of the test substance was assessed according to OECD Test Guideline 471 using a bacterial reverse mutation method. There was no increase in revertant colonies with or without metabolic activation.

The genotoxic potential of the test substance was assessed according to OECD Test Guideline 473 using an in vitro mammalian chromosome aberration method.  The test substance did not induce chromosome aberrations, when tested to its limit of cytotoxicity, in both the absence and presence of a rat liver metabolic activation.

The genotoxic potential of the test substance was assessed according to OECD Test Guideline 490 using an in vitro mammalian cell gene mutation method. There was no increase in mutation frequency with or without metabolic activation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

A mutation is defined as a permanent chance in the amount or structure of the genetic material in a cell. The term “mutation” applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications. The terms “genotoxic” and “genotoxicity” apply to agents or processes which alter the structure, information content or segregation of DNA, including those which cause DNA damage by interfering with normal replication processes, or which in a non-physiological manner alter is replication. Genotoxicity test results are usually taken as indicators for mutagenic effects.

The hazard class is primarily concerned with substances which may cause mutations in the germ cells of humans that can be transmitted to progeny. However, the results from mutagenicity or genotoxicity test in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances within this hazard class.

There are two main hazard categories for germ cell mutations; Category 1 where substances are known to induce heritable mutations or to be regarded as if they induce heritable mutation in the germ cells of humans, and Category 2 containing substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.

Classification in Category 2 is based on positive evidence obtained from experiments in mammals and some in vitro experiments

The test substance was assessed for genotoxic potential in two in vitro tests.

The substance was assessed according to OECD 471 using a bacterial reverse mutation method. There was no increase in the number of revertant colonies for any of the tester strains after treatment with the test substance, demonstrating that neither the test substance, nor any of the metabolites formed by the metabolic activation system are mutagenic. 

The genotoxic potential of the test substance was assessed according to OECD 473 using an in vitro mammalian chromosome aberration method. The test substance did not induce chromosome aberrations in cultured human peripheral blood lymphocytes, when tested to its limit of cytotoxicity, demonstrating that neither the test substance, nor any of the metabolites formed by the metabolic activation system are mutagenic.

The genotoxic potential of the test substance was assessed according to OECD Test Guideline 490 using an in vitro mammalian cell gene mutation method. The test substance was not mutagenic in the TK mutation test system under the experimental conditions used in the test.