. 2022 Aug 17;20(8):e07420. doi: 10.2903/j.efsa.2022.7420

Table E.1.

Summary of additional in vitro genotoxicity data on 2‐phenylcrotonaldehyde [FL‐no: 05.062] of subgroup 3.3

Chemical name [FL‐no]	Test system in vitro	Test object	Concentrations of substance and test conditions	Result	Reference	Comments
2‐Phenylcrotonaldehyde [FL‐no: 05.062]	Reverse Mutation test	S. typhimurium TA98, TA100, TA1535, TA1537 E. coli WP2 uvrA	1.5, 5.0, 15, 50, 150, 500, 1,500 and 5,000 μg/plate ^(a) ^, ^(b) ^, ^(c) 15, 50, 150, 500, 1,000, 1,500 and 5,000 μg/plate ^(a) ^, ^(b)	Positive	BioReliance (2016)	Reliable without restrictions. Study performed according to OECD TG 471 and in compliance with GLP.
Micronucleus assay with CREST staining	Human TK6 cells	20, 40, 45 μg/mL ^(d) ^, ^(f) 40, 60, 80 μg/mL ^(e) ^, ^(f) 5, 15, 20 μg/mL (assay 1) 16, 18, 20 μg/mL (assay 2) ^(d) ^, ^(g)	Negative Negative Positive	BioReliance (2018a)	Reliable without restrictions. Study performed according to OECD TG 487 and in compliance with GLP. The given concentrations are those for the cultures that were scored for micronuclei. CREST analysis indicates that 2‐phenylcrotonaldehyde induced MN by an anuegenic mechanism.

Chemical name

[FL‐no]

Test system in vitro

Test object

Concentrations of substance and test conditions

Result

Reference

Comments

2‐Phenylcrotonaldehyde

[FL‐no: 05.062]

Reverse Mutation test

S. typhimurium

TA98, TA100, TA1535, TA1537

E. coli WP2 uvrA

1.5, 5.0, 15, 50, 150, 500, 1,500 and 5,000 μg/plate ^(a) ^, ^(b) ^, ^(c)

15, 50, 150, 500, 1,000, 1,500 and 5,000 μg/plate ^(a) ^, ^(b)

Positive

BioReliance (2016)

Reliable without restrictions. Study performed according to OECD TG 471 and in compliance with GLP.

Micronucleus assay with CREST staining

Human TK6 cells

20, 40, 45 μg/mL ^(d) ^, ^(f)

40, 60, 80 μg/mL ^(e) ^, ^(f)

5, 15, 20 μg/mL (assay 1)

16, 18, 20 μg/mL (assay 2) ^(d) ^, ^(g)

Negative

Positive

BioReliance (2018a)

Reliable without restrictions. Study performed according to OECD TG 487 and in compliance with GLP.

The given concentrations are those for the cultures that were scored for micronuclei.

CREST analysis indicates that 2‐phenylcrotonaldehyde induced MN by an anuegenic mechanism.

^(a)

With and without S9 metabolic activation.

^(b)

Plate incorporation method.

^(c)

Preliminary toxicity and mutagenicity test.

^(d)

Without S9 metabolic activation.

^(e)

With S9 metabolic activation.

^(f)

4‐h incubation with 23‐h recovery period.

^(g)

27‐h incubation with no recovery period.