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. 2024 Nov 14;22(11):e9016. doi: 10.2903/j.efsa.2024.9016

TABLE 5.

Compositional data, intake values (calculated for chickens for fattening at 10 mg/kg complete feed), reference points, margin of exposure (MOE) for the individual components of clary sage oil classified according to assessment groups, and combined margin of exposure (MOET) for each assessment group.

Essential oil composition Exposure Hazard characterisation Risk characterisation
Assessment group FLAVIS‐No Highest conc. in the oil Highest feed conc. Daily intake 1 Cramer class 2 NOAEL 3 MOE 4 MOET 5
Constituent % mg/kg mg/kg bw/day mg/kg bw/day
CG 3
Geranyl acetate 09.011 2.61 0.261 0.0234 (I) 345 14,730
Neryl acetate 09.213 1.37 0.137 0.0123 (I) 345 28,134
(E)‐2‐Hexen‐1‐ol 0.22 0.022 0.0020 I 3 1526
MOET CG 3 1318
CG 6
α‐Terpineol 02.014 3.85 0.385 0.0346 (I) 125 6 3615
Sclareol 02.206 1.18 0.118 0.0106 (I) 4.4 7 414
Spathulenol 0.31 0.031 0.0028 I 3 1089
3,7‐Dimethylocta‐1,5,7‐trien‐3‐ol 0.07 0.007 0.0006 II 0.91 1513
2‐(4‐Methylphenyl)propan‐2‐ol 02.042 0.03 0.003 0.0003 I 3 10,780
MOET CG 6 229
CG 7
(2R,5E)‐Caryophyll‐5‐en‐12‐al 0.05 0.005 0.0005 I 3 6305
CG 8
d,l‐Borneol 02.016 0.13 0.013 0.0012 (I) 15 12,469
d,l‐Bornyl acetate 09.218 0.07 0.007 0.0006 (I) 15 23,207
Acorenone B 1.38 0.007 0.0006 II 0.91 1428
MOET CG 8 1214
CG 9
1,6‐Octadiene‐1,3‐diol, 3,7‐dimethyl‐ 0.12 0.012 0.0011 III 0.15 137
CG 10
4‐Hydroxy‐4‐methylpentan‐2‐one 07.165 0.04 0.004 0.0004 I 3 8569
CG 13
Linalool oxide 13.140 0.03 0.003 0.0002 II 0.91 3899
CG 15
Phenyl acetaldehyde 05.030 0.02 0.002 0.0002 I 3 15,913
CG 16
Sclareol oxide 0.30 0.030 0.0027 II 0.91 337
(Z)‐Dehydroxylinalool oxide 0.06 0.006 0.0006 II 0.91 1609
(E)‐Dehydroxylinalool oxide 0.05 0.005 0.0004 II 0.91 2027
β‐Dihydroagarofuran 0.04 0.004 0.0006 III 0.15 398
3,6‐Dihydro‐4‐methyl‐2‐(2‐methylprop‐1‐en‐1‐yl)‐2H‐pyran 13.088 0.03 0.003 0.0002 II 0.91 3270
MOET CG 16 145
CG 21
4‐(4‐Methyl phenyl) pentanal 0.04 0.004 0.0004 I 3 7595
CG 31, I
Octane 0.08 0.008 0.0007 I 3 4126
Tridecane 0.03 0.003 0.0003 I 3 11,523
Nonane 0.01 0.001 0.0001 I 3 27,848
3‐Methylnonane 0.01 0.001 0.0001 I 3 30,380
MOET CG 31, I 2513
CG 31, II (Acyclic alkanes)
Myrcene 01.008 1.10 0.110 0.0098 (I) 44 4468
(E)‐β‐Ocimene 0.83 0.083 0.0074 (I) 44 5912
(Z)‐β‐Ocimene 01.064 0.54 0.054 0.0049 (I) 44 9060
trans‐β‐Farnesene 0.40 0.040 0.0036 (I) 44 12,346
α‐Farnesene 01.040 0.23 0.023 0.0010 (I) 44 21,591
(E,E)‐7,11,15‐Trimethyl‐3‐methylene‐hexadeca‐1,6,10,14‐tetraene 0.11 0.011 0.0010 I 3 2984
MOET CG 31, II 1035
CG 31, IV (Benzene hydrocarbons, alkyl)
(E)‐1‐(6,10‐Dimethylundeca‐5,9‐dien‐2‐yl)‐4‐methylbenzene 0.05 0.005 0.0004 I 3 6305
Isopentyl curcumene 0.06 0.003 0.0003 I 3 10,780
MOET CG 31, IV 3978
CG 31, V (Bi‐, tricyclic, non‐aromatic hydrocarbons)
β‐Caryophyllene 01.007 2.66 0.266 0.0210 (I) 222 9283
Bicyclogermacrene 1.20 0.120 0.0095 (I) 222 20,608
α‐Copaene 1.15 0.115 0.0091 (I) 222 21,504
MOET CG 31, V 4932
CG 31, VI (macrocyclic non‐aromatic hydrocarbons)
Germacra‐1(10),4(14),5‐triene 01.042 6.46 0.646 0.0580 I 3 52
CG 32
β‐Caryophyllene epoxide 16.043 0.36 0.036 0.0032 (III) 109 33,634
Epoxylinalyl acetate 0.05 0.005 0.0005 III 0.15 321
6,10‐Epoxy‐7(14)‐isodaucane 0.04 0.004 0.0004 III 0.15 389
19,975
1

Intake calculations for the individual components are based on the use level of 10 mg/kg in feed for chickens for fattening, the species with the highest ratio of feed intake/body weight.

2

When a NOAEL value is available or read‐across is applied, the allocation to the Cramer class is put into parentheses.

3

Values in bold refer to those components for which the NOAEL value was available, values in italics are the 5th percentile of the distribution of NOAELs of the corresponding Cramer Class, other values (plain text) are NOAELs extrapolated by using read‐across.

4

The MOE for each component is calculated as the ratio of the reference point (no observed adverse effect level, NOAEL) to the intake.

5

The combined margin of exposure (MOET) is calculated for each assessment group as the reciprocal of the sum of the reciprocals of the MOE of the individual substances.

6

An uncertainty factor of 2 was applied to the NOAEL of 250 mg/kg bw per day for terpineol (short duration of the study).

7

An uncertainty factor of 2 was applied to the NOAEL of 8.8 mg/kg bw per day for sclareol (short duration of the study).