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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
A bacterial reverse mutation test with the test item was performed acording to OECD 471 using the plate incorporation method with and without metabolic activation. Based on the results, the test item is regarded as non-mutagenic in the bacterial reverse mutation test. [BASF, 2013]
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: modern OECD guideline study, conducted according to GLP
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay
Test material information:
Composition 1
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
33 μg - 5 000 μg/plate (SPT)
10 μg - 2 500 μg/plate (PIT; TA strains without S9 mix)
33 μg - 5 000 μg/plate (PIT; TA strains with S9 mix, E.coli with and without S9 mix)
Negative controls:
yes
Solvent controls:
yes
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
other: 2-aminoanthracene, N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylenediamine
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
SPT: from 1000 µg/plate; PIT: from 2500 µg/plate
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Under the experimental conditions chosen, it is concluded that 3-Formyltetrahydrofuran is not a mutagenic test substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation.
Executive summary:

The test substance 3-Formyltetrahydrofuran was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay. A biologically relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test substance 3 -Formyltetrahydrofuran is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Currently, there are two reliable bacterial reverse mutation tests with 3 -Formyltetrahydrofuran available:

According to the results of the key study (OECD 471), 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 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 or nearby 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 chosen here, it is concluded that 3 -Formyltetrahydrofuran is not a mutagenic test substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation. [BASF, 2013]

In the supporting study, a bacterial reverse mutation test with the test item was also performed acording to OECD 471 using the plate incorporation method with and without metabolic activation. The doses tested in the mutagenicity assay were selected based on the results of a dose range finding study using tester strains TA100 and WP2uvr A(pKM101) and ten doses of test article ranging from 5,000 to 6.67 µg per plate, one plate per dose, in both the presence and absence of S9mix. The tester strains used in the mutagenicity study were Salmonella typhimurium tester strains TA98, TA100, TA1535, TA1537, and Escherichia coli tester strain WP2uvrA(pKM101). The assay was conducted with six doses of test article in both the presence and absence of S9mix with concurrent vehicle and positive controls using three plates per dose. The doses tested were 5000, 3330, 1000, 333, 100, and 33.3 µg per plate in both the presence and absence of S9 mix. The results of the initial mutagenicity assay were confirmed in an independent experiment. [Covance Laboratories, 1998]

The results of both assaya indicate that the test item does not cause a positive increase in the number of revertants per plate of any of the tester strains either in the presence or absence of S9. Thus the test item is regarded as non-mutagenic in the bacterial reverse mutation test.


Justification for selection of genetic toxicity endpoint
GLP and guideline compliant study

Justification for classification or non-classification

Based on the results obtained in the in vitro study the test item is not considered to be genotoxic and thus is not to classified according to Directive 67/548/EEC and Regulation (EC) No 1272/2008.