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EC number: 906-089-0 | CAS number: -
- 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
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- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
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- Dissociation constant
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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- 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
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- 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
- Study period:
- 22 October 2020 - 19 November 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 26 June 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Geranyl propionate
- EC Number:
- 203-344-1
- EC Name:
- Geranyl propionate
- Cas Number:
- 105-90-8
- Molecular formula:
- C13H22-O2
- IUPAC Name:
- (2E)‐3,7‐dimethylocta‐2,6‐dien‐1‐yl propanoate
- Test material form:
- liquid
1
Method
- Target gene:
- Salmonella typhimurium strains: Histidine
Escherichia coli WP2uvrA: Tryptophan
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: Each tester strain contained additional mutations
- Remarks:
- rfa : deep rough (defective lipopolysaccharide cellcoat) gal : mutation in the galactose metabolism chl : mutation in nitrate reductase bio : defective biotin synthesis uvrB: loss of the excision repair system (deletion of the ultraviolet-repair B gene)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: male Sprague Dawley rats that had been injected intraperitoneally with Aroclor 1254 (500 mg/kg body weight)
- method of preparation of S9 mix: S9-mix was prepared immediately before use and kept refrigerated. S9-mix contained per 10 mL: 30 mg NADP and 15.2 mg glucose-6-phosphate in 5.5 mL Milli-Q water; 2 mL 0.5 M sodium phosphate buffer pH 7.4; 1 mL 0.08 M MgCl2 solution; 1 mL 0.33 M KCl solution. The above solution was filter (0.22 μm)-sterilized.
- concentration of S9: 5% (v/v) S9-fraction - Test concentrations with justification for top dose:
- Dose-range finding test: 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate.
The highest concentration of the test item used in the subsequent mutation assays was 5000 μg/plate or the level at which the test item inhibited bacterial growth.
First experiment Direct Plate Assay: 52, 164, 512, 1600 and 5000 μg/plate.
Second experiment Pre-incubation assay: 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate (TA1537, TA98, TA100 and WP2uvrA); 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate (TA1535; test item was tested up to concentrations of 1600 μg/plate and 5000 μg/plate in respectively the absence and presence of S9-mix)
Third experiment Pre-incubation assay: 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate (TA100; concentrations of 1600 μg/plate and 5000 μg/plate in respectively the absence and presence of S9-mix) - Vehicle / solvent:
- - Vehicle used: DMSO
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2AA)
- Remarks:
- With metabolic activation
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: ICR-191
- Remarks:
- Without metabolic acivation
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: 3
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation) or preincubation
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period: 30 ± 2 minutes by 70 rpm at 37 ± 1°C
- Exposure duration/duration of treatment: 48 ± 4 h in the dark at 37.0 ± 1.0°C
- Harvest time after the end of treatment: Not reported
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: bacterial background lawn - Evaluation criteria:
- In addition to the criteria stated below, any increase in the total number of revertants should
be evaluated for its biological relevance including a comparison of the results with the historical control data range.
A test item is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is not greater than two times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three times the concurrent control.
b) The negative response should be reproducible in at least one follow up experiment.
A test item is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is greater than two times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537 or TA98 is greater than three times the concurrent control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one follow up experiment.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: no cytotoxicity nor precipitates, but tested up to and including recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- FIRST EXPERIMENT: DIRECT PLATE ASSAY (dose-range finding study with two tester strains is reported as part of the direct plate assay)
- Precipitate: Precipitation of the test item on the plates was not observed in any tester strain.
- Toxicity: Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, was observed in the absence of S9-mix in TA98 and in the presence of S9-mix in TA1535, TA1537 and TA98.
- Mutagenicity: In the direct plate test, no increase in the number of revertants was observed upon treatment with the test item under all conditions tested.
SECOND EXPERIMENT: PRE-INCUBATION ASSAY
- Precipitate: Precipitation of the test item on the plates was not observed any tester strain.
- Toxicity: Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, was observed in all tester strains in the absence and presence of S9-mix, except in WP2uvrA in the absence of S9-mix.
- Mutagenicity: In the pre-incubation test, no increase in the number of revertants was observed upon treatment with the test item under all conditions tested.
THIRD EXPERIMENT: PRE-INCUBATION ASSAY
- Precipitate: Precipitation of the test item on the plates was not observed.
- Toxicity: Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, was observed in the absence and presence of S9-mix.
- Mutagenicity: In the pre-incubation test, no increase in the number of revertants was observed upon treatment with the test item under all conditions tested.
Any other information on results incl. tables
Table 1. Dose-Range Finding Test: Mutagenic Response of Geranyl Propionate in the Salmonella typhimurium Reverse Mutation Assay and in the Escherichia coli Reverse Mutation Assay
Direct Plate Assay
(µg/plate) |
| ||
|
|
|
|
Without S9-mix
Positive control | 812 | ± | 91 |
| 1254 | ± | 59 |
|
|
|
|
|
Solvent control | 101 | ± | 4 |
| 22 | ± | 2 |
|
|
|
|
|
1.7 | 75 | ± | 2 |
| 18 | ± | 2 |
|
|
|
|
|
5.4 | 81 | ± | 14 |
| 18 | ± | 3 |
|
|
|
|
|
17 | 88 | ± | 11 |
| 14 | ± | 8 |
|
|
|
|
|
52 | 76 | ± | 7 |
| 22 | ± | 3 |
|
|
|
|
|
164 | 82 | ± | 5 |
| 19 | ± | 4 |
|
|
|
|
|
512 | 77 | ± | 9 |
| 21 | ± | 2 |
|
|
|
|
|
1600 | 81 | ± | 6 |
| 19 | ± | 8 |
|
|
|
|
|
5000 | 96 | ± | 24 | n NP | 17 | ± | 11 | n NP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
With S9-mix
Positive control | 1248 | ± | 165 |
| 254 | ± | 25 |
|
|
|
|
|
Solvent control | 75 | ± | 6 |
| 17 | ± | 9 |
|
|
|
|
|
1.7 | 73 | ± | 15 |
| 21 | ± | 4 |
|
|
|
|
|
5.4 | 75 | ± | 8 |
| 20 | ± | 1 |
|
|
|
|
|
17 | 66 | ± | 2 |
| 18 | ± | 4 |
|
|
|
|
|
52 | 72 | ± | 5 |
| 22 | ± | 10 |
|
|
|
|
|
164 | 82 | ± | 15 |
| 28 | ± | 10 |
|
|
|
|
|
512 | 70 | ± | 4 |
| 28 | ± | 9 |
|
|
|
|
|
1600 | 80 | ± | 7 |
| 27 | ± | 5 |
|
|
|
|
|
5000 | 89 | ± | 11 | n NP | 22 | ± | 3 | n NP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NP | No precipitate |
n | Normal bacterial background lawn |
Table 2. Experiment 1: Mutagenic Response of Geranyl Propionate in the Salmonella typhimurium Reverse Mutation Assay
Direct Plate Assay
(µg/plate) |
| ||
|
|
|
|
Without S9-mix
Positive control | 987 | ± | 114 |
| 1403 | ± | 151 |
| 1777 | ± | 181 |
|
Solvent control | 5 | ± | 2 |
| 3 | ± | 2 |
| 16 | ± | 5 |
|
52 | 10 | ± | 2 |
| 4 | ± | 3 |
| 7 | ± | 5 |
|
164 | 11 | ± | 4 |
| 3 | ± | 2 |
| 9 | ± | 5 |
|
512 | 8 | ± | 0 |
| 1 | ± | 2 |
| 6 | ± | 3 |
|
1600 | 8 | ± | 2 |
| 3 | ± | 4 |
| 12 | ± | 8 |
|
5000 | 8 | ± | 2 | n NP | 6 | ± | 1 | n NP | 6 | ± | 3 | n NP a |
|
|
|
|
|
|
|
|
|
|
|
|
|
With S9-mix
Positive control | 277 | ± | 68 |
| 300 | ± | 76 |
| 923 | ± | 786 |
|
Solvent control | 5 | ± | 2 |
| 5 | ± | 2 |
| 15 | ± | 5 |
|
52 | 11 | ± | 7 |
| 8 | ± | 2 |
| 19 | ± | 5 |
|
164 | 9 | ± | 4 |
| 3 | ± | 2 |
| 12 | ± | 2 |
|
512 | 6 | ± | 2 |
| 7 | ± | 2 |
| 9 | ± | 2 |
|
1600 | 5 | ± | 5 | n | 4 | ± | 1 | n | 13 | ± | 4 | n |
5000 | 4 | ± | 1 | NP s |
|
| NP e MC |
|
| NP e MC | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
MC | Microcolonies |
NP | No precipitate |
a | Bacterial background lawn absent |
e | Bacterial background lawn extremely reduced |
n | Normal bacterial background lawn |
s | Bacterial background lawn slightly reduced |
Table 3. Experiment 2: Mutagenic Response of Geranyl Propionate in the Salmonella typhimurium Reverse Mutation Assay and in the Escherichia coli Reverse Mutation Assay
Pre-incubation Assay
(µg/plate) |
| ||||
|
|
|
|
|
|
Without S9-mix
Positive control | 1022 | ± | 49 |
| 134 | ± | 45 |
| 1415 | ± | 175 |
| 1438 | ± | 95 |
| 1224 | ± | 152 |
|
Solvent control | 11 | ± | 1 | 5 | ± | 2 |
| 12 | ± | 9 | i | 75 | ± | 9 |
| 14 | ± | 4 | i | |
Positive control |
| - |
|
| 177 | ± | 14 | * |
| - |
|
|
| - |
|
|
| - |
|
|
Solvent control |
| - |
|
| 5 | ± | 3 | * |
| - |
|
|
| - |
|
|
| - |
|
|
1.7 | 10 | ± | 3 |
| 4 | ± | 3 | * |
| - |
|
|
| - |
|
|
| - |
|
|
5.4 | 8 | ± | 6 | n | 4 | ± | 2 | * |
| - |
|
|
| - |
|
|
| - |
|
|
17 | 6 | ± | 2 | s | 3 | ± | 2 |
| 13 | ± | 8 | n | 78 | ± | 15 | i | 18 | ± | 3 |
|
52 | 7 | ± | 2 | s | 5 | ± | 2 |
| 8 | ± | 4 | s | 75 | ± | 6 | i | 24 | ± | 6 |
|
164 | 6 | ± | 1 | s | 3 | ± | 2 | n | 11 | ± | 2 | s | 61 | ± | 15 | n | 22 | ± | 6 |
|
512 | 7 | ± | 3 | s |
|
|
| e MC | 7 | ± | 2 | s |
|
|
| e MC | 14 | ± | 2 |
|
1600 | 4 | ± | 1 | m NP | 0 | ± | 0 | a | 7 | ± | 6 | s |
|
|
| e MC | 17 | ± | 6 |
|
5000 |
| - |
|
| 0 | ± | 0 | a NP | 8 | ± | 2 | NP s | 0 | ± | 0 | a NP | 19 | ± | 4 | NP n |
With S9-mix
Positive control | 213 | ± | 3 |
| 157 | ± | 16 |
| 473 | ± | 4 |
| 690 | ± | 38 |
| 373 | ± | 23 |
|
Solvent control | 10 | ± | 6 | 5 | ± | 2 |
| 15 | ± | 3 |
| 73 | ± | 5 |
| 16 | ± | 4 |
| |
Positive control |
| - |
|
|
| - |
|
| 674 | ± | 34 | * |
| - |
|
|
| - |
|
|
Solvent control |
| - |
|
|
| - |
|
| 14 | ± | 6 | * |
| - |
|
|
| - |
|
|
1.7 |
| - |
|
|
| - |
|
| 16 | ± | 4 | * |
| - |
|
|
| - |
|
|
5.4 |
| - |
|
|
| - |
|
| 19 | ± | 6 | * |
| - |
|
|
| - |
|
|
17 | 8 | ± | 5 | 2 | ± | 2 | s | 23 | ± | 4 | i | 68 |
| s ii | 19 | ± | 9 |
| ||
52 | 8 | ± | 4 | 1 | ± | 2 | s | 12 | ± | 6 |
| 30 | ± | 12 | s | 17 | ± | 2 |
| |
164 | 8 | ± | 2 | n | 2 | ± | 3 | s | 17 | ± | 8 | n | 58 |
| s ii | 22 | ± | 3 | n | |
512 | 0 | ± | 0 | a | 5 | ± | 6 | s |
|
| e MC | 27 | ± | 13 | m | 10 | ± | 4 | s | |
1600 | 0 | ± | 0 | a | 2 | ± | 2 | m i | 0 | ± | 0 | a | 36 | ± | 15 | m |
|
|
| e MC |
5000 | 0 | ± | 0 | a NP | 1 | ± | 1 | m NP i | 0 | ± | 0 | a NP | 39 | ± | 10 | m NP |
|
|
| e NP MC |
MC | Microcolonies |
NP | No precipitate |
a | Bacterial background lawn absent |
e | Bacterial background lawn extremely reduced |
i | Plate infected: mean of two plates |
ii | Two plates infected: single plate count |
m | Bacterial background lawn moderately reduced |
n | Normal bacterial background lawn |
s | Bacterial background lawn slightly reduced |
* | Data from an additional experiment |
- | Not tested |
Table 4. Experiment 3: Mutagenic Response of Geranyl Propionate in the Salmonella typhimurium Reverse Mutation Assay
Pre-incubation Assay
(µg/plate) |
| ||||
| TA100 |
|
|
Without S9-mix
| Positive control | 811 | ± | 17 |
|
| ||||||||||||
| Solvent control | 108 | ± | 6 |
|
| ||||||||||||
| 1.7 | 107 | ± | 16 |
|
| ||||||||||||
| 5.4 | 87 | ± | 21 | n |
| ||||||||||||
| 17 | 59 | ± | 14 | s |
| ||||||||||||
| 52 | 61 | ± | 8 | m |
| ||||||||||||
| 164 | 27 | ± | 14 | m |
| ||||||||||||
| 512 | e MC |
| |||||||||||||||
| 1600 | e MC NP |
| |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
With S9-mix
Positive control | 1939 | ± | 96 |
|
Solvent control | 95 | ± | 21 |
|
17 | 86 | ± | 8 |
|
52 | 81 | ± | 3 | n |
164 | 77 | ± | 5 | s |
512 | a | |||
1600 | a | |||
5000 | a NP |
MC | Microcolonies |
NP | No precipitate |
a | Bacterial background lawn absent |
e | Bacterial background lawn extremely reduced |
m | Bacterial background lawn moderately reduced |
n | Normal bacterial background lawn |
s | Bacterial background lawn slightly reduced |
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and the Escherichia coli Reverse Mutation Assay performed according to OECD 471 (2020).
- Executive summary:
Substance is tested in the Ames test (OECD TG 471). The following concentrations were tested in 3 independent experiments, 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate. In the first mutation experiment, cytotoxicity was seen as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, in the absence of S9-mix in TA98 and in the presence of S9-mix in TA1535, TA1537 and TA98. In the second mutation experiment, cytotoxicity was seen, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, in all tester strains in the absence and presence of S9-mix, except in WP2uvrA in the absence of S9-mix. Because of plate infections and excessive toxicity in tester strain TA100 in the second experiment, an additional third mutation experiment was performed. Cytotoxicity was seen, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, in the absence and presence of S9-mix. There were no positive results in all strains. Based on this the substance is not mutagenic in this test.
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