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EC number: 232-107-5 | CAS number: 7787-20-4
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro gene mutation study in bacteria. Key study. Experimental study following method equivalent to OECD guideline 471. The test item was found to be not mutagenic with or without metabolic activation in any of the Salmonella typhimurium tested strains.
In vitro gene mutation study in mammalian cells. Key study: Experimental study following method equivalent to OECD guideline 490. The test substance was found positive in the Mouse Lymphoma Assay in the presense and in the absence of metabolic activation.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine-requiring gene in Salmonella typhimurium
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 homogenate prepared from male Sprague-Dawley rats and Syrian golden hamsters induced with Aroclor 1254.
- Test concentrations with justification for top dose:
- 0, 100, 333, 1000, 3333 and 10000 μg/plate.
These doses were selected based on the levels of cytotoxicity observed in a preliminary dose range-finding study using strain TA100. Ten dose levels, one plate per dose, were tested in both the presence and the absence of induced hamster S9. As no toxicity was observed, a total maximum dose of 10 mg per plate was used. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Direct plate incorporation method: For testing in the absence of S9 mix, 100 μL of the tester strain and 50 μL of the solvent or test chemical were added to 2.5 mL of molten selective top agar at 45 ± 2 ºC. When S9 was used, 0.5 mL of S9 mix, 50 μL of tester strain, and 50 μL of solvent or test chemical were added to 2.0 mL of molten selective top agar at 45 ± 2 ºC. After it was vortexed, the mixture was overlaid onto the surface of 25 mL of minimal bottom agar. After the overlay had solidified, the plates were incubated for 48 h at 37 ± 2 ºC.
- Cell density at seeding: Cultures were grown overnight in Oxoid nutrient broth no. 2 and were removed from incubation when they reached a density of 1-2x10e9 cells/mL.
DURATION
- Exposure duration: 48h
SELECTION AGENT (mutation assays): the lack of amino-acid in the medium. Only the mutants can grow due to their capability to synthesize the essential amino acid.
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
No toxicity was observed in a preliminary dose range-finding study using strain TA100. - Evaluation criteria:
- For the test substance to be considered positive, it had to induce at least a doubling (TA98, TA100, and TA1535) in the mean number of revertants per plate of at least one tester strain. This increase in the mean revertants per plate had to be accompanied by a dose response to increasing concentrations of the test substance. If the study showed a dose response with a less than 3-fold increase on TA1537 or TA1538, the response had to be confirmed in a repeat experiment.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
The doses that were tested in the mutagenicity assay were selected based on the levels of cytotoxicity observed in a preliminary dose range-finding study using strain TA100. Ten dose levels of the chemical, one plate per dose, were tested in both the presence
and the absence of induced hamster S9. As no toxicity was observed, a total maximum dose of 10 mg of test chemical per plate was used in the main study. - Conclusions:
- L-fenchone was not mutagenic in all strains tested with and without metabolic activation.
- Executive summary:
L-fenchone was tested for mutagenecity on Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102 with and without metabolic activation (S9 mix prepared from both rat and hamster liver). The experiment was performed using the Ames Salmonella assay for mutagenicity. In a preliminary dose range-finding study ten dose levels of the test substance, one plate per dose, were tested in both the presence and the absence of induced hamster S9 using strain TA100. As no toxicity was observed, a maximum dose of 10 mg per plate was used. Based on this preliminary study, the selected doses for the main study were 0, 100, 333, 1000, 3333 and 10000 μg/plate. Ethanol was used as solvent and tested as negative control. Under these experimental conditions, the test substance was found not mutagenic in all strains tested with and without metabolic activation.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
- Target gene:
- Thymidine Kinase Gene
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Dr. Donald Clive, Burroughs Wellcome Co. (Research Triangle Park, NC).
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: Fischer’s medium for leukemic cells of mice (Gibco, Grand Island, NY, or Quality Biological, Gaithersburg, MD) supplemented with 10% horse serum (Gibco or Hyclone, Logan, UT) and 0.02% pluronic F-68 (BASF Wyandotte Corp., Wyandotte, MI). - Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 prepared from Aroclor 1254-induced male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- ± S9 mix: 250, 500, 600 and 650 μg/mL.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: not specified. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ( DMSO)
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium.
- Cell density at seeding (if applicable): Cells in the cultures were adjusted to 3x10e5/mL at 24 h intervals. They were then cloned (1x10e6 cells/plate for mutant selection and 200 cells/plate for viable count determinations) in soft agar medium.
DURATION
- Exposure duration: 4h
- Expression time (cells in growth medium, to allow expression of the TK- mutation ): 48h
- Selection time (plating for -trifluorothymidine (TFT) resistance): 10-12 days
SELECTION AGENT (mutation assays): trifluorothymidine (TFT) (final concentration, 3 µg /mL)
NUMBER OF REPLICATIONS: Duplicate cultures were used for each treatment.
NUMBER OF CELLS EVALUATED: 1.2 x 10e7 cells
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (RTG)
- Any supplementary information relevant to cytotoxicity: The toxicity was determined both with and without liver S9 prepared from Aroclor 1254-induced male Sprague-Dawley rats. Cells at a concentration of 6 x 10e5/mL (6 x10e6 cells total) were exposed for 4 h to a range of concentrations from 0.0005 to 10000 µg/mL. The cells were then washed, resuspended in growth medium, and incubated at 37 ± 1ºC for 48 h. The rate of cell growth was determined for each of the treated cultures and compared to the rate of growth of the solvent control. The doses of chemical selected for testing were within the range yielding approximately 0-90% cytotoxicity. - Evaluation criteria:
- Mutant frequencies were expressed as mutants per 10e6 surviving cells.
A positive result was interpreted following two different methods:
1. Using a doubling of the mutant frequency over the concurrent solvent-treated control value, together with evidence of a dose-related increase (cited as old evaluation in the report).
2. if a concentration-related increase in mutant frequency is observed and one or more dose levels with 10% or greater total growth exhibit mutant frequencies of ≥100 mutants per 10e6 clonable cells over the background level (cited as new evaluation in the report). - Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Culture 1: 5-66% RTG; Culture 2: 3-84% RTG
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Culture 1: 5-66% RTG; Culture 2: 3-84% RTG
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Culture 1: 4-112% RTG; Culture 2: 7-101% RTG
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: "old evaluation" as cited in the report
- Conclusions:
- The test substance was found positive in the Mouse Lymphoma Assay in the presense and in the absence of metabolic activation.
- Executive summary:
An in vitro mammalian cell assay was performed in mouse lymphoma L5178Y TK+/- 3.7.2 C cells at the tk locus (OECD test guideline 490) to test the potential to cause gene mutation. Treatment was performed for 4 hours with and without metabolic activation (±S9 mix). DMSO was used as solvent. The test item was examined up to 10000 μg/mL in the cytotoxicity Test. Based on these results, the test item concentrations in the mutation assay were 250, 500, 600 and 650 μg/mL. The experiments were performed using appropriate negative (vehicle) and positive control samples. Two different criteria were used to determine a positive response. Only the one using a doubling of the mutant frequency over the negative control as an indication of a positive effect, together with evidence of a dose-related increase, was considered valid for the final results of the test compound. Under conditions of the assay, the test substance was found positive in the presense and in the absence of metabolic activation.
Referenceopen allclose all
Table 3 Salmonella Test Data
Chemical Name |
CAS # |
Dose |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
||||||||||
|
|
|
no S9 |
rat S9 |
Ham'r S9 |
no S9 |
rat S9 |
Ham'r S9 |
no S9 |
rat S9 |
Ham'r S9 |
no S9 |
rat S9 |
Ham'r S9 |
no S9 |
rat S9 |
Ham'r S9 |
(1R)-(-)-Fenchone |
7787-20-4 |
|
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
|
|
EtOH |
17 ± 4 |
27 ± 9 |
15 ± 5 |
112 ± 19 |
127 ± 16 |
132 ± 21 |
324 ± 29 |
366 ± 13 |
324 ± 41 |
8 ± 2 |
8 ± 3 |
10 ± 2 |
4 ± 2 |
8 ± 4 |
6 ± 2 |
|
|
100ug |
16 ± 3 |
36 ± 7 |
21 ± 6 |
111 ± 4 |
109 ± 15 |
123 ± 9 |
317 ± 30 |
309 ± 13 |
355 ± 9 |
9 ± 1 |
9 ± 2 |
9 ± 1 |
4 ± 2 |
5 ± 2 |
8 ± 1 |
|
|
333ug |
16 ± 3 |
38 ± 12 |
22 ± 4 |
103 ± 12 |
126 ± 5 |
134 ± 15 |
354 ± 28 |
270 ± 47 |
368 ± 32 |
10 ± 3 |
11 ± 1 |
8 ± 3 |
4 ± 2 |
6 ± 1 |
5 ± 3 |
|
|
1000ug |
16 ± 5 |
35 ± 3 |
19 ± 4 |
101 ± 25 |
119 ± 28 |
111 ± 14 |
272 ± 34 |
333 ± 7 |
370 ± 24 |
9 ± 2 |
10 ± 4 |
9 ± 2 |
4 ± 2 |
5 ± 1 |
5 ± 3 |
|
|
3333ug |
16 ± 5 |
22 ± 4 |
23 ± 7 |
121 ± 18 |
131 ± 18 |
105 ± 12 |
312 ± 29 |
289 ± 16 |
395 ± 39 |
10 ± 1 |
9 ± 3 |
10 ± 2 |
6 ± 1 |
4 ± 2 |
7 ± 3 |
|
|
10000ug |
15 ± 3 |
27 ± 8 |
19 ± 4 |
116 ± 11 |
113 ± 9 |
104 ± 19 |
324 ± 60 |
321 ± 21 |
396 ± 34 |
12 ± 4 |
11 ± 4 |
10 ± 1 |
6 ± 2 |
4 ± 1 |
5 ± 2 |
|
|
Positive |
285 ± 57 |
470 ± 276 |
1260 ± 199 |
570 ± 72 |
792 ± 487 |
1176 ± 113 |
1189 ± 138 |
1562 ± 60 |
1056 ± 100 |
767 ± 117 |
73 ± 117 |
102 ± 14 |
2088 ± 415 |
54 ± 32 |
108 ± 44 |
Table 4 Mouse Lymphoma Test Data
Non-Activated Cultures |
S9-Activated Cultures |
||||||||||
Chemical Name |
Solvent |
Dose (ug/mL) |
Average TFT |
Average VC |
Mut Freq |
RTG |
Dose (ug/mL) |
Average TFT |
Average VC |
Mut Freq |
RTG |
(1R)-(-)-Fenchone |
DMSO |
|
|
|
|
|
|
|
|
|
|
|
|
250 |
51 |
191 |
0,53 |
66 |
250 |
70 |
181 |
0,78 |
112 |
|
|
|
55 |
237 |
0,46 |
84 |
|
46 |
163 |
0,56 |
101 |
|
|
500 |
56 |
154 |
0,73 |
14 |
500 |
176 |
62 |
5,66 |
38 |
|
|
|
59 |
145 |
0,82 |
15 |
|
173 |
51 |
6,84 |
28 |
|
|
600 |
73 |
142 |
1,03 |
10 |
600 |
176 |
63 |
5,58 |
18 |
|
|
|
60 |
131 |
0,92 |
9 |
|
168 |
57 |
5,87 |
15 |
|
|
650 |
59 |
129 |
0,91 |
5 |
650 |
147 |
57 |
5,17 |
4 |
|
|
|
59 |
90 |
1,31 |
3 |
|
153 |
76 |
4,01 |
7 |
|
|
Solvent |
50 |
194 |
0,61 |
|
Solvent |
47 |
172 |
0,54 |
|
|
|
Positive |
218 |
107 |
4,06 |
32 |
Positive |
222 |
118 |
3,77 |
46 |
Interpretation of results:
-Non activated cultures: positive according to criterion 1 (doubling of the mutant frequency over the negative value together with evidence of a dose-related increase) and negative according to criterion 2 (concentration-related increase in mutant frequency is observed and one or more dose levels with 10% or greater total growth exhibit mutant frequencies of g100 mutants per 106 clonable cells over the background level).
-S9 activated cultures: positive according to both criteria (see definions above).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro gene mutation study in bacteria. Key study. L-fenchone was tested for mutagenecity on Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102 with and without metabolic activation (S9 mix prepared from both rat and hamster liver). The experiment was performed using the Ames Salmonella assay for mutagenicity. In a preliminary dose range-finding study ten dose levels of the test substance, one plate per dose, were tested in both the presence and the absence of induced hamster S9 using strain TA100. As no toxicity was observed, a maximum dose of 10 mg per plate was used. Based on this preliminary study, the selected doses for the main study were 0, 100, 333, 1000, 3333 and 10000 μg/plate. Ethanol was used as solvent and tested as negative control. Under these experimental conditions, the test substance was found not mutagenic in all strains tested with and without metabolic activation.
In vitro gene mutation study in mammalian cells. Key study: An in vitro mammalian cell assay was performed in mouse lymphoma L5178Y TK+/- 3.7.2 C cells at the tk locus (OECD test guideline 490) to test the potential to cause gene mutation. Treatment was performed for 4 hours with and without metabolic activation (±S9 mix). DMSO was used as solvent. The test item was examined up to 10000 μg/mL in the cytotoxicity Test. Based on these results, the test item concentrations in the mutation assay were 250, 500, 600 and 650 μg/mL. The experiments were performed using appropriate negative (vehicle) and positive control samples. Two different criteria were used to determine a positive response. Only the one using a doubling of the mutant frequency over the negative control as an indication of a positive effect, together with evidence of a dose-related increase, was considered valid for the final results of the test compound. Under conditions of the assay, the test substance was found positive in the presense and in the absence of metabolic activation.
Justification for classification or non-classification
Based on the available information, further studies are required to conclude on classification of the test substance in accordance with CLP Regulation (EC) no 1272/2008.
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