Table D.1.
Summary of 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 |
S. typhimurium TA98, TA100, TA1535, TA1537 and TA102 |
1.6, 8, 40, 200, 1,000 and 5,000 μg/plate (a) , (b) | Negative | Kilford (2010) | Toxicity was observed in all strains at 5,000 μg/plate in the absence and presence of S9‐mix, and at 1,000 μg/plate and above in strains TA98 and TA102 in the absence of S9‐mix and in strains TA1537 and TA102 in the presence of S9‐mix. All strains were negative. Study design complied with current recommendations. Acceptable top concentration was achieved. |
|
S. typhimurium TA98, TA100, TA1535 TA1537 and TA102 |
51.2, 128, 320, 800, 2,000 and 5,000 μg/plate (b) , (d) | Negative | Kilford (2010) | Toxicity was observed in strains TA1537 and TA102 at 2,000 μg/plate and above in the absence of S9‐mix and at 320 μg/plate in the presence of S9‐mix. Similar toxicity was also observed in strains TA98, TA100 and TA1535 at 5,000 μg/plate in the absence of S9 and at 800 μg/plate and above in the presence of S9‐mix. Statistically significant differences in mutation frequency were observed only in strain TA100 and only at levels of toxicity (in the absence of S9‐mix at a concentration of 2,000 μg/plate and in the presence of S9‐mix at 320 μg/plate). Study design complied with current recommendations. Acceptable top concentration was achieved. | ||
|
S. typhimurium TA98, TA100, TA1535 |
51.2, 128, 320, 800, 2,000 and 5,000 μg/plate (c) , (e) | Negative | ||||
| S. typhimurium TA1537 and TA102 | 20.48, 51.2, 128, 320, 800, 2,000 μg/plate (c) , (e) | Negative | ||||
|
S. typhimurium TA98, TA100, TA1535 |
31.25–1,000 μg/plate (c) , (e) | Negative | Kilford (2010) | Toxicity was observed at 3,500 μg/plate and above in strain TA100 in the absence of S9‐mix. In the presence of S9‐mix, toxicity was observed at 250 μg/plate and above in strains TA1537 and TA102 and at 1,000 μg/plate and above in strains TA100, TA98 and TA1535. | ||
|
S. typhimurium TA1537, TA102 |
15.625–500 μg/plate (c) , (e) | Negative | ||||
|
S. typhimurium TA100 |
320–5,000 μg/plate (b) , (d) | Negative | ||||
|
Micronucleus induction |
Human peripheral blood lymphocytes |
40, 60, 100, 120 |
Positive | Lloyd (2012) | The MNBN cell frequencies increases were statistically significant at the top two concentrations, but only slightly exceeded the 95% range of historical controls at the highest dose. All other treated cultures fell within the normal range. The study complies with OECD TG 487. | |
| 100, 130, 140 μg/mL (e) , (f) 20, 23, 26 μg/mL (d) , (g) |
Negative Negative |
Lloyd (2012) | The MNBN cell frequencies increases were statistically significant at the top two concentrations, but all treated cultures fell within the normal range. The study complies with OECD TG 487. | |||
| 20, 60, 70 and 80 μg/mL (d) , (f) | Positive | Lloyd (2012) | The MNBN cell frequencies in both cultures at 20 and 70 μg/mL and in one culture at 80 μg/mL exceeded the 95th percentile of the historical control range. The study complies with OECD TG 487. |
(a)
With and without S9 metabolic activation.
(b)
Plate incorporation method.
(c)
Pre‐incubation method.
(d)
Without S9 metabolic activation.
(e)
With S9 metabolic activation.
(f)
3‐h incubation with 21‐h recovery period.
(g)
24‐h incubation with no recovery period.