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EC number: 283-900-8 | CAS number: 84775-71-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Ocimum basilicum, Labiatae.
- 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
- Study period:
- The study was conducted between 28 August 2017 - 21 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ocimum basilicum, ext.
- EC Number:
- 283-900-8
- EC Name:
- Ocimum basilicum, ext.
- Cas Number:
- 84775-71-3
- Molecular formula:
- not applicable
- IUPAC Name:
- 3,7-dimethylocta-1,6-dien-3-ol
- Test material form:
- liquid
1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix from male Sprague Dawley rats injected intraperitoneally with Aroclor 1254 (500 mg/kg body weight).
- Test concentrations with justification for top dose:
- - Dose range finding test (reported as part of experiment 1):
TA 100 and WP2uvrA (without and with S9): 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 µg/plate
- Experiment 1
TA 98, TA1535 and TA1537 (without and with S9): 5.4, 17, 52, 164, 512 and 1600 µg/plate
- Experiment 1A:
TA 98 and TA 1535 (without and with S9): 1600 and 5000 µg/plate
- Experiment 2:
TA 98, TA 100, TA 1535, TA 1537 and WP2uvrA (without and with S9): 17, 52, 164, 512, 1600 and 5000 µg/plate
For each experiment, doses were determined based on the results of preceeding experiments. - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: the substance was dissolved in dimethyl sulfoxide.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: ICR-191; 2-aminoanthracene
- Remarks:
- For more details on positive controls, see 'other information on materials and methods' section.
- Details on test system and experimental conditions:
- Two independent experiments were performed, at first a direct plate assay and secondly a pre-incubation assay.
METHOD OF APPLICATION: in agar
DURATION
- Preincubation period (experiment 2 only): 30 ± 2 minutes
- Exposure duration (both experiments): 48 ± 4 hours
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain (in all experiments)
DETERMINATION OF CYTOTOXICITY
- Method: on the basis of a decline in the number of spontaneous revertants, a thinning of the background lawn or a microcolony formation. - Evaluation criteria:
- INTERPRETATION:
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 (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three (3) 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 (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537 or TA98 is greater than three (3) 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.
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.
ACCEPTABILITY CRITERIA:
- The vehicle control and positive control plates from each tester strain (with or without S9-mix) must exhibit a characteristic number of revertant colonies when compared
against relevant historical control data generated at the test facility.
- The selected dose-range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate.
- No more than 5% of the plates are lost through contamination or some other unforeseen event. If the results are considered invalid due to contamination, the experiment will be repeated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At 5000 µg/plate in experiment 1A and at and above 512 µg/plate in experiment 2.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At 1600 µg/plate in experiment 1 and at and above 512 µg/plate in experiment 2.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At 5000 µg/plate in experiment 1A and at and above 512 µg/plate in experiment 2.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At 1600 and 5000 µg/plate in experiment 1 and at and above 512 in experiment 2.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Only at and above 1600 µg/plate in experiment 2.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Since in experiment 1 no cytotoxicity was observed in tester strains TA98 and TA1535, an additional experiment was performed (1A) to assess the cytotoxicity of these strains at concentrations of 1600 and 5000 μg/plate.
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In both experiments, precipitation of the test item on the plates was observed at the start of the incubation period at the concentration of 5000 μg/plate. No precipitation was observed at the end of the incubation period.
HISTORICAL CONTROL DATA (see table 2 and 3 in 'any other informationon results'):
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
EXPERIMENT 1:
Cytotoxicity was observed in all strains, with and without S9, except for strain WP2uvrA.
TA1537: 1600 µg/plate
TA100: 1600 and 5000 µg/plate
EXPERIMENT 1A:
TA1535: 5000 µg/plate
TA98: 5000 µg/plate
EXPERIMENT 2:
Cytotoxicity was observed in all strains, with and without S9.
TA1535: ≥ 512 µg/plate
TA1537: ≥ 512 µg/plate
TA98: ≥ 512 µg/plate
TA100: ≥ 512 µg/plate
WP2uvrA ≥ 1600 µg/plate
Any other information on results incl. tables
Table 2 Historical data of solvent controls
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
|||||
S9-mix |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
Range |
3 - 36 |
3 - 32 |
3 – 20 |
3 – 23 |
8 - 41 |
9 - 55 |
66 - 161 |
63 - 160 |
10 – 59 |
9 - 69 |
Mean |
11 |
11 |
6 |
7 |
16 |
23 |
105 |
105 |
25 |
31 |
SD |
4 |
4 |
3 |
3 |
5 |
7 |
19 |
20 |
7 |
8 |
n |
2057 |
2039 |
1950 |
1931 |
2023 |
2083 |
2027 |
2033 |
1739 |
1745 |
SD = Standard deviation; n = Number of observations
Table 3 Historical data of positive controls
|
TA1535 |
TA1537 |
TA98 |
|||
S9-mix |
- |
+ |
- |
+ |
- |
+ |
Range |
125 - 1381 |
78 - 1058 |
55 – 1324 |
55 – 1051 |
410 – 1995 |
250 - 1977 |
Mean |
839 |
220 |
736 |
382 |
1369 |
929 |
SD |
153 |
112 |
331 |
150 |
310 |
345 |
n |
2065 |
1967 |
1740 |
1933 |
1920 |
2014 |
|
TA100 |
WP2uvrA |
||
S9-mix |
- |
+ |
- |
+ |
Range |
537 – 1848 |
408 - 2651 |
93 – 1951 |
93 - 1359 |
Mean |
908 |
1330 |
1128 |
422 |
SD |
178 |
324 |
484 |
151 |
n |
2007 |
2020 |
1679 |
1728 |
SD = Standard deviation; n = Number of observations
Historical control data from experiments performed between May 2015 and May 2017.
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and Escherichia coli reverse mutation assay performed according to OECD 471 guideline and GLP principles.
- Executive summary:
The mutagenic activity of the substance was evaluated in accordance with OECD TG 471 and according to GLP principles. The test was performed in two independent experiments (one direct plate and one pre-incubation test) up to and including 5000 µg/plate, in the absence and presence of S9-mix. The dose levels were selected based on observed cytotoxicity in a dose range finding test (reported as part of experiment 1). Adequate positive controls and a solvent control were included. The substance did not precipitate on the plates.
In the first experiment 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 strains TA100 and TA1537 (1600 µg/plate) in the absence and presence of S9-mix. Since no cytotoxocity was observed in strains TA98 and TA1535, these were tested in an additional experiment (1A) to assess the cytotoxicity at dose levels of 1600 and 5000 µg/plate. In this additional experiment strains TA98 and TA1535 showed cytotoxicity at a dose level of 5000 µg/plate. In the second experiment, cytotoxicity was observed in all Salmonella strains at and above 512 µg/plate and above, with and without S9, and in tester strain WP2uvrA at and above 1600 µg/plate and above, with and without S9. No mutagencity was observed in any of the experiments, in all tester strains, with and without S9. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and not mutagenic in the Escherichia coli reverse mutation assay.
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