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Key value for chemical safety assessment

Additional information

Gene mutation in bacteria

Currently, there is one key study available.

According to the results of the study, the test substance did not lead to a biologically relevant increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in two several experiments carried out independently of each other

(standard plate test and preincubation assay). Besides, the results of the negative as well as the positive controls performed in parallel

corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study. In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain. In addition, the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data or above. Under the experimental conditions of this study, the test substance 3-Aminomethyl-THF is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation. [BASF, 2013]

In an second study with the test substance shows no evidence of mutagencid activity in this bacterial system. In this in vitro assessment of the mutagenic potential of F AM, histidine dependent auxotrophic mutants of Salmonella typhimurium, strains TA 1535, TA 1537, TA 98 and TA 100, and a tryptophan dependent mutant of Escherichia co/i, strain WP2uvrA/pK.Ml01 (CM891), were exposed to the test substance. Two independent mutation tests were performed in the presence and absence of liver preparations from Aroclor 1254-induced rats (S9 mix). The first (range-finding) was a standard plate incorporation assay; the second involved a pre-incubation stage. Concentrations of F AM up to 5000 μglplate were tested in the mutation tests. No signs of toxicity were observed towards the tester strains in either mutation test [Mitsui Chem Inc., 1999]

Cytogenicity in mammalian cells

Currently, there is one key study available.

The clastogenicity of 3-furanmethanamine (FAM) was evaluated by a short-time treatment method using cultured mammalian cells (CHL/IU). Four dosages were used, namely 50, 100, 200 and 400 μg/mL when the metabolic activation method was not used, and 125, 250, 500 and 1000 μg/mL when the metabolic activation method was used, and the structural and numerical chromosome aberrations were investigated. In the results of the chromosome aberration tests, compared to a negative control, no significant increase in the numerical aberration cells was observed when the metabolic activation method was not used, but a significant and dose-dependent increase in structural aberration cells was seen. On the other hand, when the metabolic activation method was used, no significant increase in cells having structural and numerical chromosome aberrations was seen compared to a negative control. On the basis of the above results, it was concluded that FAM showed clastogenicity (structural aberration) with respect to CHL/IU cells when the metabolic activation method was not used. [Shin Nippon Biomedical Laboratories Ltd., 2000]

Other studies

Currently, there is no information available.

Cytogenicity in vivo

Currently, there is one key study available.

The test substance 3-Aminomethyl-THF was assessed for its potential to induce chromosomal damage (clastogenicity) or spindle poison effects (aneugenic activity) in NMRI mice using the micronucleus test method. For this purpose, the test substance, dissolved in deionized water, was administered once orally to male animals at dose levels of 300 mg/kg, 600 mg/kg and 1 200 mg/kg body weight in a volume of 10 mL/kg body weight in each case. The animals were sacrificed and the bone marrow of the two femora was prepared 24 and 48 hours after administration in the highest dose group of 1 200 mg/kg body weight and in the vehicle controls. A slight inhibition of erythropoiesis determined from the ratio of polychromatic to normochromatic erythrocytes was detected after test substance administration at 48-hour sacrifice interval (1 200 mg/kg body weight). Thus, the bioavailability of the test substance in blood and bone marrow was confirmed. According to the results of the present study, the single oral administration of 3-Aminomethyl- THF did not lead to any relevant increase in the number of polychromatic erythrocytes containing either small or large micronuclei. The rate of micronuclei was close to the range of the concurrent vehicle control in all dose groups and at all sacrifice intervals and within the range of the historical vehicle control data. Thus, under the experimental conditions of this study, the test substance 3-Aminomethyl-THF does not induce cytogenetic damage in bone marrow cells of NMRI mice in vivo [BASF, 2015].


Short description of key information:
Gene mutation in bacteria
Ames test with and without metabolic activation (OECD 471): negative [BASF, 2013]
Ames test with and without metabolic activation (OECD 471): negative [Mitsui Chem Inc, 1999]

Gene mutation in mammalian cells
Currently, there is no information available.

Cytogenicity in mammalian cells
Chromosome aberration test with mammalian CHL cells with and without metabolic activation (OECD 473): positive [Shin Nippon Biomedical Laboratories Ltd, 2000]

Cytogenicity in vivo
Micronucleus Test in Bone Marrow Cells of the Mouse (OECD 474): negative [BASF, 2015]

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

Based on the available data for the test substance and for 3 -furanmethanamine is not subject to C&L according to Regulation 1272/2008/EC and Directive 67/548/EEC.