Tricyclodecanedimethanol

Endpoint summary

Additional information

Three studies studies have been identified to assess the genetic toxicity potential of octahydro-4,7-methano-1H-indenedimethanol (TCD-Alcohol DM). In all studies, no evidence was found for a mutagenic/genotoxic potential of octahydro-4,7-methano-1H-indenedimethanol.

 

Ames Test

 

In a reverse gene mutation assay in bacteria, strains of S. typhimurium (TA98, TA100, TA1535, TA1537 and TA1538) were exposed to octahydro-4,7-methano-1H-indenedimethanol (98.5%) in DMSO at concentrations of 8, 40, 200, 1000, and 5000 µg/plate (plate incorporation assay) and 62.5, 125, 250, 500, and 1000 µg/plate (pre-incubation assay) in the presence and absence of mammalian metabolic activation (S9 mix from Aroclor induced male rat liver). 

 

Octahydro-4,7-methano-1H-indenedimethanol did not increase the number of revertants in any of the test strains. There was no evidence of induced mutant colonies over background (Huels AG, 1992).

 

This study is classified as acceptable. Although a pre-guideline study, it satisfies the requirement of Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.

 

Mammalian Chromosome Aberration Test

 

In a mammalian cell cytogenetics assay (Chromosome aberration test in Vitro), CHO cell cultures were exposed to octahydro-4,7-methano-1H-indenedimethanol in DMSO at concentrations ranging from 0 up to 2500 µg/mL in a preliminary toxicity study and from 0 to about 940 µg/mL in the chromosome aberration study in the presence and absence of mammalian metabolic activation (S9 mix of Aroclor 1254 induced livers of male rats).

 

There was no evidence for a concentration related response of chromosomal aberrations induced over background. The test substance was shown to be non-clastogenic to CHO cells in vitro (Hoechst/Safepharm, 1992).

 

This study is classified as acceptable. This study satisfies the requirements for Test Guideline OECD 473 and EU B.10 (In Vitro Mammalian Chromosomal Aberration Test) for in vitro cytogenetic mutagenicity data.

 

Mammalian Cell Gene Mutation Test (HPRT-assay)

 

In a mammalian cell gene mutation assay (HPRT locus) CHO cells cultured in vitro were exposed to octahydro-4,7-methano-1H-indenedimethanol (98.5%) at concentrations ranging from 0 up to 2.0 mg/mL in the presence and absence of mammalian metabolic activation (S9 mix of Aroclor 1254 induced rat liver). Due to toxicity, the maximal test concentrations in mutation tests were 0.1 and 0.25 mg/mL in experiment without metobolic activation and 1.5 mg/mL in experiments with metabolic activation.

 

There was no evidence or a concentration related positive response of induced mutant colonies over background under the test conditions used (Hüls AG, 1992).

 

This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 476 for in vitro mutagenicity (mammalian forward gene mutation) data. Limitations result from the low maximal test concentrations used for experiments without metabolic activation.

Justification for selection of genetic toxicity endpoint
No study selected, since all three in vitro studies were negative

Short description of key information:
Octahydro-4,7-methano-1H-indenedimethanol (TCD-Alcohol DM) was found not to be mutagenic in an in-vitro reverse gene mutation assays in bacteria according to Ames with and without metabolic activation. In addition, octahydro-4,7-methano-1H-indenedimethanol did not show genotoxic potential in mammalian cells in an HPTR mutation assay and a Chromosomal Abberation test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Octahydro-4,7-methano-1H-indenedimethanol (TCD-Alcohol DM) has not to be classified as mutagenic or germ cell mutagen according to Regulation (EC) No 1272/2008. It was shown to be negativ in three different in-vitro mutagenicity/genotoxicity tests in bacteria and in mammalian cells.