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. 2019 May 22;17(5):e05676. doi: 10.2903/j.efsa.2019.5676

Table D.1.

Genotoxicity data (in vitro)

Chemical name [FL‐no] Test system Test object Concentration Reported result Reference Commentsc
α‐Ionone [07.007] Chromosomal aberration Chinese hamster B241 cell line 25 nmol/L Positivea Kasamaki et al. (1982) Limited validity (limited documentation; results for only one test concentration reported; long incubation period of 24 h; unusual cell line)
Reverse mutation S. typhimurium TA98, TA100 0.01–50 μg/plate Negativea Kasamaki et al. (1982) Limited validity (insufficiently reported; only two strains)
Rec assay B. subtilis H17 & M45 19 mg/disc Negativeb Oda et al. (1978) Insufficient validity. This bacterial DNA‐repair test system is of low predictive value for genotoxicity
Methyl‐α‐ionone [07.009] Reverse mutation S. typhimurium TA1535, TA1537, TA1538, TA98, TA100 5 concentrations up to cytotoxicity or max 3,600 μg/plate Negativea Wild et al. (1983) Limited validity (no TA102 or E. coli)
Methyl‐δ‐ionone [07.088] Reverse mutation S. typhimurium TA1535, TA1537, TA1538, TA98, TA100 5 concentrations up to cytotoxicity or max 3,600 μg/plate Negativea Wild et al. (1983) Limited validity (no TA102 or E. coli)
a

With and without metabolic activation.

b

Activation status unknown.

c
Validity of genotoxicity studies:
  • Valid.
  • Limited validity (e.g. if certain aspects are not in accordance with OECD Guidelines or current standards and/or limited documentation).
  • Insufficient validity (e.g. if main aspects are not in accordance with any recognised guidelines (e.g. OECD) or current standards and/or inappropriate test system).
  • Validity cannot be evaluated (e.g. insufficient documentation, short abstract only, too little experimental details provided).