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EC number: 203-376-6 | CAS number: 106-23-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets basic scientific principles, sufficient documentation
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Mutagenicity testing of (±)-camphor, 1,8-cineole, citral, citronellal, (-)-menthol and terpineol with the Salmonella/microsome assay
- Author:
- Gomes-Carneiro M.R., Felzenswalb I., Paumgartten F.J.R.
- Year:
- 1 998
- Bibliographic source:
- Mutat Res 416, 129 - 136
- Reference Type:
- other: abstract
- Title:
- Evaluation of the mutagenic potential of monoterpenoid compounds
- Author:
- Gomes Carneiro M.R., Paumgartten F.J.R., Felzenswalb I.
- Year:
- 1 997
- Bibliographic source:
- Mutat Res 379, Suppl 1, S111
- Reference Type:
- other: abstract
- Title:
- Evaluation of the mutagenic potential of monoterpenoid compounds
- Author:
- Gomes Carneiro M.R., Paumgartten F.J.R., Felzenswalb I.
- Year:
- 1 997
- Bibliographic source:
- Mutat Res 379, Suppl 1, S110
- Reference Type:
- secondary source
- Title:
- Mutagenicity testing of (±)-camphor, 1,8-cineole, citral, citronellal, (- )-menthol and terpineol with the Salmonella/microsome assay
- Author:
- Gomes-Caneiro, et al.
- Year:
- 1 998
- Bibliographic source:
- cited in: WHO FOOD ADDITIVES SERIES (52): Safety evaluation of certain food additives and contaminants
- Reference Type:
- secondary source
- Title:
- Mutagenicity testing of (±)-camphor, 1,8-cineole, citral, citronellal, (- )-menthol and terpineol with the Salmonella/microsome assay
- Author:
- Gomes-Carneiro MR, et al.
- Year:
- 1 998
- Bibliographic source:
- cited in: RIFM-FEMA Database CAS 106-23-0 RIFM ID 156 FEMA 2307
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Principles of method if other than guideline:
- Plate incorporation assay performed according to the revised method of Maron and Ames (1983, Mutat. Res. 113, 173-215)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Citronellal
- EC Number:
- 203-376-6
- EC Name:
- Citronellal
- Cas Number:
- 106-23-0
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethyloct-6-enal
- Details on test material:
- - Name of test material (as cited in study report): Citronellal
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 97a, TA 98, TA 100, TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 fraction (Aroclor 1254 induced)
- Test concentrations with justification for top dose:
- -S9: TA 100: 5 - 200 µg/plate; TA 98: 5 - 200 µg/plate; TA 97a: 5 - 150 µg/plate; TA 102: 1 - 50 µg/plate
+S9: TA 100: 5 - 200 µg/plate; TA 98: 5 - 300 µg/plate; TA 97a: 5 - 200 µg/plate; TA 102: 5 - 200 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: solubility of the test substance
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (TA 100 and 98, +S9), sodium azide (TA 100, -S9), nitro-o-phenylenediamine (TA 98, -S9), 4-nitroquinolone-n-oxide (TA 97a, -S9), 2-aminofluorene (TA 97a, +S9), mitomycin C (TA 102/-S9), benzo(a)pyrene (TA 102/+S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: none
- Exposure duration: 72 hr
NUMBER OF REPLICATIONS: 3, repeated in at least 2 assays
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of revertants or as an alteration of the auxotrophic background growth - Evaluation criteria:
- not specified
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 300 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Dose finding study:
Table 1: Cytotoxicity of citronellal in S. typhimurium T100 strain
Dose (µg/plate) |
mean mutant count/plate |
|
-S9 |
+S9 |
|
500 |
1/0/0 + |
- |
400 |
52/3/0 + |
3/3+ |
300 |
82/29/0 + |
154/75 (*)/0+ |
200 |
139 ± 12 |
179 ± 23 |
solvent ctrl |
174 ± 15 |
184 ± 26 |
positive ctrl |
924 ± 41 |
591 ± 69 |
(*) Toxicity apparent as an alteration of the background lawn
/+ Mutant counts of individual plates
(-) Dose not tested
Data are shown as mutant counts (mean ± SD) of three plates
Due to the cytotoxic effects after treatment with 400 µg/plate and higher, the main study was undertaken with concentrations below 400 µg/plate.
Main study:
Table 2: Mutagenity testing of citronellal in Salmonella / microsome assay with the strains TA100, TA98, TA97a, and TA102
Monoterpene |
Dose (µg/plate) |
Number of revertants (mean ± SD) |
|||||||
Citronellal |
TA100 |
TA98 |
TA97a |
TA102 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
||
300 |
- |
- |
- |
47 ± 14 (*) |
- |
- |
- |
- |
|
200 |
131 ± 12 |
172 ± 11 |
29 ± 3 |
54 ± 1 |
- |
174 ± 25 |
- |
645 ± 50 (*) |
|
150 |
151 ± 11 |
- |
34 ± 11 |
- |
125 ± 8 |
- |
- |
706 ± 55 |
|
100 |
152 ± 10 |
199 ± 12 |
42 ± 1 |
57 ± 6 |
146 ± 19 |
218 ± 30 |
- |
655 ± 41 |
|
50 |
167 ± 4 |
196 ± 18 |
31 ± 2 |
61 ± 4 |
153 ± 13 |
181 ± 31 |
548 ± 62 |
846 ± 28 |
|
30 |
156 ± 11 |
- |
- |
- |
- |
- |
674 ± 70 |
- |
|
25 |
- |
203 ± 9 |
- |
- |
167 ± 16 |
225 ± 2 |
- |
751 ± 66 |
|
20 |
- |
- |
- |
- |
- |
- |
631 ± 35 |
- |
|
10 |
164 ± 14 |
205 ± 14 |
32 ± 6 |
70 ± 8 |
152 ± 16 |
187 ± 16 |
599 ± 81 |
787 ± 66 |
|
5 |
186 ± 12 |
201 ± 14 |
36 ± 6 |
62 ± 11 |
158 ± 18 |
211 ± 19 |
612 ± 20 |
752 ± 26 |
|
1 |
- |
- |
- |
- |
- |
- |
646 ± 56 |
- |
|
solvent ctrl |
182 ± 14 |
201 ± 16 |
49 ± 16 |
70 ± 6 |
157 ± 2 |
212 ± 17 |
628 ± 12 |
771 ± 37 |
|
positive ctrl |
907 ± 63 |
1165 ± 151 |
208 ± 1 |
312 ± 33 |
749 ± 25 |
1002 ± 101 |
5351 ± 101 |
2024 ± 182 |
|
Solvent control: 100 µl ethanol p.a.
(-) Dose not tested.
(*) Toxicity apparent as an alteration of the background lawn.
Values are the means ± SD of three plates of one (out of two) representative experiment.
Applicant's summary and conclusion
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