Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Mutagenicity in bacteria:

In the key study performed under GLP according to OECD guideline 471, bacteria strains S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 were incubated with doses of 1.5, 5, 15, 50, 150, 500 and 1500 µg/plate tetrahydrogeraniol with metabolic activation by Aroclor 1254 induced rat liver S9 homogenate, and with 1.5, 5, 15, 50, 150 and 500 µg/plate without metabolic activation (King Harnasch 2001). Cytotoxicity was observed at 500 and/or 1500 µg/plate. No significant increase in the mutation frequency of the tester strains has been found in the absence and presence of a metabolic activation system. Therefore tetrahydrogeraniol was found to be not mutagenic in bacteria under the chosen testing conditions.

No study on gene mutation or cytogenicity in mammals/mammalian cells are available for tetrahydrolgeraniol. However, structurally comparable substances i.e. tetrahydrolinalool, isodecanol and 2-propylheptanol all share the same functional groups, belong to the group of the saturated branched chain alcohols and contain comparable chain lengths as tetrahydrogeraniol. Therefore, data from these analogous substances have been used for read across. 

Gene mutation in mammalian cells in vitro:

Tetrahydrolinalool did no induce gene mutations in a HPRT assay using V79 cells (according to OECD TG 476 and GLP) up to cytotoxic concentrations with and without metabolic activation (BASF 1998; 50M0021/989002).

2-Propylheptanol was tested in a HPRT-test (according to OECD TG 476, under GLP) with Chinese hamster ovary cells (CHO) and showed no increase of mutant frequencies up to cytotoxic concentrations with and without metabolic activation (BASF 2011; 50M0356/02M004).

Cytogenicity in mammalian cells in vitro:

In a chromosomal aberration assay according to OECD TG 473 and GLP using V79 Chinese hamster fibroblasts, tetrahydrolinalool was found to be negative for causing chromosomal abberations up to cytotoxic concentrations with and without metabolic activation (BASF 1998; 32M0021/989001).

Isodecanol was tested in an in vitro mammalian chromosome aberration study performed under GLP according to OECD guideline 473 (Fraunhofer Institute 1993). Isodecanol induced no chromosomal aberrations in cultured mammalian V79 cells with/without metabolic activation.

According to the OECD SIDS for members of the Oxo Alcohols C9 to C13 Category as structurally analogs to tetrahydrogeraniol, the following is stated: “Based on the lack of effects found in the limited studies available and based on data for similar linear alcohols used as analogues, the members of the Oxo Alcohols C9 to C13 Category are considered to have a low genotoxic potential” (SIDS INITIAL ASSESSMENT PROFILE, attached to 7.12).

Overall in a weight of evidence, tetrahydrolgeraniol is considered to have no genotoxic potential based on the data presented above.


Short description of key information:
Genetic toxicity:
- Mutagenicity in bacteria (OECD 471, GLP): negative (King Harnasch 2001)
- Gene mutation in mammalian cells in vitro (OECD 476, GLP): negative (analogy: tetrahydrolinalool CAS 78-69-3; BASF 1998; 50M0021/989002)
- Gene mutation in mammalian cells in vitro (OECD 476, GLP): negative (analogy: 2-propylheptanol CAS 10042-59-8; BASF 2011; 50M0356/02M004)
- Cytogenicity in mammalian cells in vitro (OECD 473, GLP): negative (analogy: tetrahydrolinalool CAS 78-69-3; BASF 1998; 32M0021/989001)
- Cytogenicity in mammalian cells in vitro (OECD 473, GLP): negative (analogy: isodecanol, CAS 25339-17-7; Fraunhofer Institute 1993)

Endpoint Conclusion:

Justification for classification or non-classification

The present data on genetic toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008 and therefore, a non-classification is warranted.