Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Salmonella typhimurium reverse mutation assay with the strains TA 97a, TA 98, TA 100 and TA 102: negative (Gomes-Carneiro 1998)
HPRT gene mutation assay in CHO cells (OECD Guideline 476, GLP): negative (BASF 50M0411/074063)
MNT in V79 cells (OECD Guideline 487, GLP): negative (BASF 33M0411/07M024)

Additional information

In the chosen key study for bacterial mutagenicity, i.e. an Ames test (Plate incorporation assay), Salmonella strains TA 97a, TA 98, TA 100, TA 102 were incubated with citronellal (1-300 µg/plate) both in the absence and presence of metabolic activation (Gomes-Carneiro 1998). No increase of revertant colonies were observed up to cytotoxic concentrations. Therefore citronellal was found to be not mutagenic in bacteria under the given testing conditions.

In the chosen key study for mutagenicity in mammalian cells, i.e. a HPRT gene mutation assay in CHO cells according to OECD TG 476 and GLP, citronellal showed no relevant dose-dependent increase in the number of mutant colonies up to cytotoxic concentrations either without S9 mix or after the addition of a metabolizing system (BASF 50M0411/074063). Thus, under the experimental conditions of this study, citronellal is considered not to be a mutagenic substance under in vitro conditions in the HPRT locus assay.

 

In the chosen key study for cytogenicity in mammalian cells, i.e. a MNT test in V79 cells according to OECD TG 487 and GLP, citronellal did not lead to a biologically relevant increase in the number of micronucleated cells up to cytotoxic concentrations either without S9 mix or after the addition of a metabolizing system in two experiments performed independently of each other. Thus, citronellal is considered not to have a chromosome-damaging (clastogenic) effect nor to induce numerical chromosomal aberrations (aneugenic activity) under in vitro conditions in V79 cells under the given experimental conditions (BASF 33M0411/07M024).

 In a supportive study, CHO K1-cells treated with citronellal did not show any increase in mean SCE frequency compared to the negative control when tested in the absence of metabolic activation up to concentrations reaching the cytotoxicity level (333 µM; Sasaki 1989).

 

Overall, on the basis of the present data, citronellal is considered to have no mutagenic or clastogenic/aneugenic activity in bacteria and mammalian cells.


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.