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. 2018 Jul 20;16(7):e05322. doi: 10.2903/j.efsa.2018.5322

Table E.2.

Additional genotoxicity data (in vivo) considered by the Panel in FGE.203Rev1

Register name [FL‐no] Test system in vivo Test object Route Dose Result Reference Comments
Deca‐2(trans),4(trans)‐dienal [05.140] Micronucleus induction Male rat bone marrow polychromatic erythrocytes i.p. 100, 200, 400 and 600 mg/kg bw Positivea NTP (2011) Study design complies with OECD Guideline 474
Male mouse bone marrow polychromatic erythrocytes i.p. 25, 50, 100 and 200 mg/kg bw Equivocalb A trend of increase but not statistically significant. Study design complies with OECD Guideline 474
Male mouse bone marrow polychromatic erythrocytes i.p. 400 and 600 mg/kg bw Positivea Significant increase only at the highest dose. Study design complies with OECD Guideline 474
Male mouse peripheral blood polychromatic erythrocytes i.p. 400 and 600 mg/kg bw Negativea No statistically significant increase of micronucleated cells was observed. Study design complies with OECD Guideline 474
Mouse peripheral blood reticulocytes gavage 50, 100, 200, 400 and 800 mg/kg bw per day Negativec No statistically significant increase of micronucleated cells was observed. Study design complies with OECD Guideline 474

bw: body weight; OECD: Organisation for Economic Co‐operation and Development.

a

Administered as a single intraperitoneal injection.

b

Administered 3x by intraperitoneal injection at 24‐h intervals.

c

Administered by gavage for a period of 14 weeks.