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. 2021 Feb 3;19(2):e06362. doi: 10.2903/j.efsa.2021.6362

Table E.2.

Summary of in vivo genotoxicity data evaluated in FGE.67Rev3

Chemical name [FL‐no] Test system Test object Route Dose (mg/kg bw per day) Result Reference Comments
2‐Acetylfuran [13.054] Micronucleus assay (peripheral blood) Muta® Mice, M Gavage 0, 15, 30 and 60 Negative Covance (2016) Reliable with restrictions (no clear evidence of bone marrow exposure). Study performed in compliance with GLP and according to OECD TG 474, but positive control was not included
Gene mutation assay in liver and duodenum Negative Reliable without restrictions. Study performed in compliance with GLP and according to OECD TG 488

2‐Pentylfuran

[13.059]

Comet assay (liver) B6C3F1 mice, M Gavage 508

Positive

Negative in the presence of proteinase K

New York Medical College, 2012

Insufficient reliability

The study aimed at comparing furan and 2‐pentylfuran. Liver was sampled 3h after treatment

762 Negative both with and without proteinase K
508, 762

Negative both with and without proteinase K

Re‐estimate: reduction of tail length at the highest dose, both with and without proteinase K

2‐Pentylfuran

[13.059]

Micronucleus assay (bone marrow) Han Wistar rats, M Gavage 42.5, 85, 170a Negative Covance (2014) Reliable with restrictions (no clear evidence of bone marrow exposure). Study performed in compliance with GLP and according to OECD TG 474
Comet assay (liver) Negative Reliable without restrictions. The study was performed in compliance with recommendations of the Comet and IWGT workshop, Japanese Center for the Validation of Alternative Methods (JaCVAM) and current literature

FL‐No: FLAVIS number; FGE: Flavouring Group Evaluation; OECD: Organization for Economic Cooperation and Development; TG: test guideline; GLP: Good Laboratory Practice; M: male.

a

Administered via gavage in 3 doses at times 0, 24 and 45 h with sacrifice and harvest at 48 h.