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EC number: 225-004-1 | CAS number: 4602-84-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to OECD 471 and GLP. The test included five strains of Salmonella typhimurium, with TA102 in place of an Escherichia coli strain.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Farnesol
- EC Number:
- 225-004-1
- EC Name:
- Farnesol
- Cas Number:
- 4602-84-0
- Molecular formula:
- C15H26O
- IUPAC Name:
- farnesol
Constituent 1
Method
- Target gene:
- Histidine reversion his- to his+
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- nitroreductase deficient
- Remarks:
- All strains: rfa- mutation; strains TA 1535, TA 1537, TA 98 and TA 100: uvrB- mutation; strains TA 98, TA 100 and TA102: R-factor mutation; strain TA 102: hisG428 mutation
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 3, 10, 33, 100. 333. 1000. 2500 and 5000 µg/plate for pre-experiment (main experiment I) and main experiment II
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO; purity >99%
- Justification for choice of solvent/vehicle: solubility properties and relative non-toxicity to the bacteria
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-ortho-phenylene -diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- EXPERIMENT I and EXPERIMENT 1A (repeat) -
In Experiment I strain TA 1537 without S9 mix showed a reduction in the number of revertants below the indication factor of 0.5 - indication of toxicity at nearly all concentrations, this part was repeated under identical conditions and reported as EXPERIMENT 1A
METHOD OF APPLICATION: In agar (plate incorporation);
DURATION
Exposure duration: - Exposure duration: at least 48 hours at 37C in the dark
NUMBER OF REPLICATIONS:Three
EXPERIMENT II
METHOD OF APPLICATION: ; pre incubation test
DURATION
- Preincubation period: 60min at 37C in the dark
- Exposure duration: at least 48 hours at 37C in the dark
-
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY determined in Experiment I
---------
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 hours
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays):
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth
- Evaluation criteria:
- Test system is considered mutagenic if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA98, TA100 and TA 102) or thrice (TA 1535 and TA1537) the colony count of the corresponding solvent control is observed. A dose dependent increase is considered biologically relevant if the threshold is exceeded at more that one concentration. An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
- Statistics:
- Not mandatory under OECD test guidleine 471
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No substantial increase in revertant colony numbers in any of the 5 tester strains was observed following treatment with the test item at any concentration level, neither in the presence or absence of metabolic activation (S9 mix) . There was also no tendency for higher mutation rates with increasing concentration below the range normally considered to be biologically significant.
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Observed in test tubes from 1000 to 5000 mcg/plate in both experiments - and on the incubated agar paltes from 2500 to 5000 mcg/plate
-
RANGE-FINDING/SCREENING STUDIES: As all plates were evaluable in the range finding study, this study was reported as Experiment I.
COMPARISON WITH HISTORICAL CONTROL DATA:
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Toxic effects were observed at the following concentrations (mcg/plate)
TA1535 : Experiment I plate test 2500-5000 +/- S9 ) ; Experiment II pre-incubation ; 2500-5000 +/- S9
TA1537 : Experiment I plate test several doses upto 5000 - S9 ;2500 +S9 ; (Experiment Ia plate test repeat) 333-5000mcg/plate -S9; Experiment II pre-incubation ; 1000 -5000 - S9 ; 333 -5000 +S9
TA98 : Experiment I plate test 5000 - S9 ;2500 +S9 ; Experiment II pre-incubation ; 100, 2500-5000 -S9 ;2500 -5000 +S9
TA100 : Experiment I plate test 333-5000 - S9 ;1000-5000 +S9 ; Experiment II pre-incubation ; 1000-5000 +/- S9
TA102 : Experiment I plate test 2500-5000+/ - S9 Experiment II pre-incubation 2500-5000+/ - S9
Any other information on results incl. tables
Table 1. Summary results of pre-experiment and Experiment I
Metabolic activation |
Test Group |
Dose Level (µg/plate) |
Revertant Colony Counts (Mean ± SD) |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
|||
Without activation |
DMSO |
|
13 ± 3 |
17 ± 3BM |
31 ± 5 |
104 ± 8BM |
526 ± 53 |
Untreated |
|
12 ± 2 |
14 ± 4BM |
32 ± 6 |
129 ± 7BM |
467 ± 24 |
|
Farnesol |
3 |
13 ± 0 |
15 ± 3BM |
29 ± 6 |
106 ± 10BM |
449 ± 21 |
|
|
10 |
15 ± 3 |
12 ± 1BM |
37 ± 12 |
12 ± 1BM |
471 ± 86 |
|
|
33 |
10 ± 6 |
6 ± 2BM |
27 ± 2 |
6 ± 2BM |
465 ± 36 |
|
|
100 |
16 ± 5MR |
6 ± 2BM |
27 ± 3 |
6 ± 2BM |
402 ± 25 |
|
|
333 |
10 ± 4RM |
7 ± 4BM |
26 ± 2 |
7 ± 4BM |
357 ± 11 |
|
|
1000 |
7 ± 1MR |
9 ± 5BM |
19 ± 0 |
9 ± 5BMR |
352 ± 21 |
|
|
2500 |
4 ± 2PMR |
6 ± 3PMB |
17 ± 4PM |
6 ± 3PMBR |
186 ± 13PM |
|
|
5000 |
4 ± 3PMR |
5 ± 2PMB |
13 ± 2PM |
5 ± 2PMB |
172 ± 16PM |
|
NaN3 |
10 |
2176 ± 87 |
|
|
2024 ± 85 |
|
|
4-NOPD |
10 |
|
|
432 ± 7BM |
|
|
|
4-NOPD |
50 |
|
117 ± 8BM |
|
|
|
|
MMS |
3.0 |
|
|
|
|
4424 ± 108 |
|
With activation |
DMSO |
|
24 ± 3 |
21 ± 6BM |
41 ± 6 |
109 ± 10BM |
551 ± 27 |
Untreated |
|
20 ± 6 |
17 ± 3BM |
35 ± 1 |
111 ± 10BM |
554 ± 21 |
|
Farnesol |
3 |
23 ± 12 |
17 ± 6BM |
36 ± 8 |
111 ± 10BM |
562 ± 74 |
|
|
10 |
24 ± 5 |
21 ± 4BM |
33 ± 10 |
103 ± 6BM |
532 ± 22 |
|
|
33 |
20 ± 6 |
16 ± 6BM |
49 ± 2 |
107 ± 12BM |
544 ± 23 |
|
|
100 |
20 ± 7 |
15 ± 6BM |
43 ± 4 |
63 ± 6BM |
526 ± 13 |
|
|
333 |
13 ± 2 |
17 ± 3BM |
28 ± 5 |
56 ± 7BM |
398 ± 39 |
|
|
1000 |
13 ± 1 |
13 ± 6BM |
30 ± 6 |
28 ± 2BMR |
379 ± 16 |
|
|
2500 |
5 ± 2PM |
7 ± 3PMB |
18 ± 1P |
21 ± 2PMBR |
215 ± 10PM |
|
|
5000 |
7 ± 1PM |
14 ± 1PMB |
19 ± 6P |
18 ± 2PMB |
223 ± 11PM |
|
2-AA |
2.5 |
308 ± 14 |
301 ± 11BM |
1686 ± 122 |
2383 ± 187 |
|
|
2-AA |
10.0 |
|
|
|
|
2214 ± 287 |
NaN3= Sodium azide
2-AA = 2-aminoanthracene
MMS = Methyl methane sulfonate
4-NOPD = 4-Nitro-o-phenylene-diamine
B = Extensive bacterial growth
M = Manual count
R = Reduced background growth
P = Precipitate
Table 2. Summary of Results Pre-Experiment and Experiment Ia
Metabolic activation |
Test Group |
Dose Level (µg/plate) |
Revertant Colony Counts (Mean ± SD) |
TA 1537 |
|||
Without activation |
DMSO |
|
15 ± 2 |
Untreated |
|
19 ± 2 |
|
Farnesol |
3 |
16 ± 4 |
|
|
10 |
13 ± 5 |
|
|
33 |
10 ± 2 |
|
|
100 |
8 ± 2 |
|
|
333 |
6 ± 3 |
|
|
1000 |
6 ± 2MR |
|
|
2500 |
3 ± 2MR |
|
|
5000 |
1 ± 1MR |
|
4-NOPD |
50 |
143 ± 17 |
4-NOPD = 4-Nitro-o-phenylene-diamine
M = Manual count
R = Reduced background death
Table 3. Summary of Results Experiment II
Metabolic activation |
Test Group |
Dose Level (µg/plate) |
Revertant Colony Counts (Mean ± SD) |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
|||
Without activation |
DMSO |
|
14 ± 1 |
11 ± 3 |
42 ± 4 |
118 ± 15 |
413 ± 9 |
Untreated |
|
13 ± 2 |
13 ± 8 |
24 ± 2 |
130 ± 10 |
485 ± 9 |
|
Farnesol |
3 |
13 ± 2 |
15 ± 4 |
25 ± 4 |
119 ± 5 |
437 ± 14 |
|
|
10 |
10 ± 2 |
13 ± 7 |
24 ± 3 |
99 ± 11 |
442 ± 23 |
|
|
33 |
15 ± 4 |
6 ± 6 |
19 ± 4 |
64 ± 7 |
406 ± 43 |
|
|
100 |
14 ± 2 |
13 ± 1 |
17 ± 5 |
71 ± 6 |
273 ± 13 |
|
|
333 |
3 ± 1MR |
6 ± 1MR |
25 ± 3MR |
59 ± 24MR |
379 ± 13MR |
|
|
1000 |
3 ± 2MR |
2 ± 3MR |
21 ± 3MR |
39 ± 8MR |
356 ± 41MR |
|
|
2500 |
0 ± 0MR |
0 ± 0MR |
11 ± 2MR |
22 ± 6MR |
123 ± 18MR |
|
|
5000 |
0 ± 1MR |
0 ± 0MR |
4 ± 2MR |
14 ± 1MR |
64 ± 8MR |
|
NaN3 |
10 |
2184 ± 27 |
|
|
2117 ± 79 |
|
|
4-NOPD |
10 |
|
|
514 ± 78 |
|
|
|
4-NOPD |
50 |
|
137 ± 27 |
|
|
|
|
MMS |
3.0 µL |
|
|
|
|
3301 ± 380 |
|
With activation |
DMSO |
|
13 ± 1 |
16 ± 1 |
30 ± 5 |
143 ± 17 |
607 ± 38 |
Untreated |
|
12 ± 1 |
20 ± 8 |
36 ± 1 |
148 ± 12 |
678 ± 42 |
|
Farnesol |
3 |
9 ± 4 |
18 ± 3 |
40 ± 9 |
148 ± 14 |
604 ± 19 |
|
|
10 |
10 ± 2 |
17 ± 8 |
43 ± 3 |
154 ± 11 |
568 ± 47 |
|
|
33 |
9 ± 2 |
16 ± 3 |
34 ± 3 |
151 ± 7 |
648 ± 23 |
|
|
100 |
8 ± 2 |
10 ± 4 |
30 ± 7 |
121 ± 13 |
588 ± 47 |
|
|
333 |
2 ± 1MR |
6 ±2MR |
34 ± 6MR |
88 ± 10MR |
523 ± 56MR |
|
|
1000 |
3 ± 3MR |
3 ± 1MR |
34 ± 1MR |
32 ± 4MR |
432 ± 67MR |
|
|
2500 |
2 ± 2MR |
1 ± 2MR |
13 ± 6MR |
22 ± 4MR |
174 ± 13MR |
|
|
5000 |
1 ± 1MR |
3 ± 3MR |
6 ± 1MR |
19 ± 2MR |
118 ± 18MR |
|
2-AA |
2.5 |
891 ± 30 |
266 ± 35 |
1858 ± 1207 |
2576 ± 61 |
|
|
2-AA |
10.0 |
|
|
|
|
2805 ± 70 |
NaN3= Sodium azide
2-AA = 2-aminoanthracene
MMS = Methyl methane sulfonate
4-NOPD = 4-Nitro-o-phenylene-diamine
B = Extensive bacterial growth
M = Manual count
R = Reduced background growth
P = Precipitate
Applicant's summary and conclusion
- Conclusions:
- No substantail increase in revertant colony numbers in any of the 5 tester strains was observed following treatment with the test item at any concentration level, neither in the presence or absence of metabolic activation (S9 mix) . There was also no tendency for higher mutation rates with increasing concentration below the range normally considered to be biologically significant. Under the experimental conditions, the test item did not induce gene mutations by base pair or frameshift in the genome of the species tested. The test item is not considered to be mutagenic in the Salmonella tyhimurium reverse transcription assay.
- Executive summary:
The study was performed to assess the potential of the test item to induce gene mutations according to the plate incorporation test (Experiment I) or the pre-incubation test (Experiment II) using Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102. The assay was performed in two independent experiments with or without liver microsomal activation (S9 mix). Since results for TA1537 without metabolic activation showed a reduction of revertants (below the indication level of 0.5) at nearly all concentrations, this part of Experiment I was repeated under identical conditions as Experiment IA. In all experiments, test concentrations ranged from 3 to 5000 µg/plate, and toxic effects were observed at the higher concentrations tested. No substantial increase in revertant colony numbers in any of the 5 tester strains was observed following treatment with the test item at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix) . There was also no tendency for higher mutation rates with increasing concentration below the range normally considered to be biologically significant. Appropriate mutagens were used as positive controls and showed a distinct increase in revertant colonies. Under the experimental conditions, the test item did not induce gene mutations by base pair or frameshift in the genome of the species tested. The test item is not considered to be mutagenic in the Salmonella typhimurium reverse transcription assay. This study is considered to be reliable without restrictions (Klimisch 1) as it was GLP-compliant and was performed according to OECD 471.
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