. 2017 May 17;15(5):e04766. doi: 10.2903/j.efsa.2017.4766

Table C.1.

Summary of Additionally In Vivo Genotoxicity Data Submitted for FGE.208Rev1

Chemical Name FL‐no	Test System in vivo	Test Object	Route	Dose	Result	Reference	Comments
p‐Mentha‐1,8‐dien‐7‐al [05.117]	Micronucleus Assay	Male Han Wistar rats	Gavage	175, 350 and 700 mg/kg bw per day	Negative	Beevers (2014a,b)	Reliable with restriction. Complies with GLP and mainly with OECD Test Guideline 474 (not clear if the bone marrow was exposed)
Comet assay	Male Han Wistar rats	Gavage	Positive	Reliable without restriction. Complies with GLP. The study was performed shortly before publication of OECD Test Guideline 489; however, it is consistent with this guideline. Positive in liver, negative in duodenum

Chemical Name FL‐no

Test System in vivo

Test Object

Route

Dose

Result

Reference

Comments

p‐Mentha‐1,8‐dien‐7‐al

[05.117]

Micronucleus Assay

Male Han Wistar rats

Gavage

175, 350 and 700 mg/kg bw per day

Negative

Beevers (2014a,b)

Reliable with restriction. Complies with GLP and mainly with OECD Test Guideline 474 (not clear if the bone marrow was exposed)

Comet assay

Male Han Wistar rats

Gavage

Positive

Reliable without restriction. Complies with GLP. The study was performed shortly before publication of OECD Test Guideline 489; however, it is consistent with this guideline. Positive in liver, negative in duodenum

bw: body weight; GLP: Good Laboratory Practice; OECD: Organisation for Economic Co‐operation and Development.