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EC number: 289-969-0 | CAS number: 90046-02-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Juniperus oxycedrus, Cupressaceae.
- 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
Ames test: non mutagenic (OECD 471, GLP, K, rel. 1).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 05 to March 13, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- March 05, 2015
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% S9: S9-mix from the liver of rats treated with Aroclor 1254 (500 mg/kg bw) by the intraperitoneal route
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 10, 100, 500, 1000, 2500 and 5000 μg/plate in the TA 98, TA 100 and TA 102 strains with and without S9-mix, using plate incorporation method.
First experiment (plate incorporation method):
312.5, 625, 1250, 2500 and 5000 μg/plate in the TA 98 and TA 102 strains, without S9-mix
78.1, 156.3, 312.5, 625, 1250 and 2500 μg/plate in the TA 100 strain, without S9-mix
1.3, 2.6, 7.7, 23.1, 69.4, 208.3 and 625 μg/plate in the TA 1535 and TA 1537 strains, without S9-mix
312.5, 625, 1250, 2500 and 5000 μg/plate in the TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains, with S9-mix
Second experiment:
without S9 mix (plate incorporation method):
156.3, 312.5, 625, 1250, 2500 and 5000 μg/plate in the TA 98 and TA 102 strains
78.1, 156.3, 312.5, 625, 1250, 2500 and 5000 μg/plate in the TA 100 strain
7.8, 15.6, 31.3, 62.5, 125, 250 and 500 μg/plate in the TA 1535 and TA 1537 strains
With S9 mix (pre-incubation method):
39.1, 78.1, 156.3, 312.5, 625 and 1250 μg/plate in the TA 1535 and TA 1537 strains
156.3, 312.5, 625, 1250, 2500 and 5000 μg/plate in the TA 98, TA 100 and TA 102 strains
Third experiment (pre-incubation method):
156.3, 234.4, 312.5, 468.8, 625, 1250 and 2500 μg/plate in the TA 98 strain, with S9-mix - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulfoxide (DMSO)
- Dose formulation preparation
The test item was dissolved in the vehicle at concentrations of:
100 mg/mL for the preliminary toxicity test; 100 mg/mL for the first experiment; 50 and 100 mg/mL for the second experiment; 50 mg/mL for the third experiment.
The stock solutions and their dilutions were prepared within 4 hours of use, and then kept at room temperature and protected from light until use - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-Anthramine
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM: Five strains of Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 were supplied by Moltox (Molecular Toxicology, INC, Boone, NC 28607, USA) or Culture Collections (Public Health England, Porton Down, Salisbury SP4 0JG, UK), depending on the strain.
METHOD OF APPLICATION: In agar (direct plate incorporation and preincubation method)
DURATION
- Preincubation period: 60 minutes at 37 °C
- Incubation period: Plates were incubated at 37 °C for 48-72 hours
NUMBER OF REPLICATIONS:
- SIngle plate/dose for preliminary toxicity test
- 3 plates/dose for main experiments
DETERMINATION OF CYTOTOXICITY
- Method: The evaluation of the toxicity was performed on the basis of the observation of a decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
OTHER:
- Number of revertants per plate was scored for each strain and for each experimental point using an automatic counter (Sorcerer Automatic Colony Counter for the scoring of colonies and Ames Study Manager for the data management, Perceptive Instruments Ltd, Bury St Edmunds IP33 3TA, UK). Also, the thinning of the bacterial lawn and the presence of precipitate were evaluated - Evaluation criteria:
- In all cases, biological relevance (such as reproducibility and reference to historical data) was taken into consideration when evaluating the results.
The test item is considered to have shown mutagenic activity in this study if:
- a reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the mean number of revertants compared with the vehicle controls is observed, in any strain, at any dose-level,
- a reproducible dose-response relationship is evidenced.
The test item is considered to have shown no mutagenic activity in this study if:
- neither an increase in the mean number of revertants, reaching 2-fold (for the TA 98, TA 100 and TA 102 strains) or 3-fold (for the TA 1535 and TA 1537 strains) the vehicle controls value, is observed at any of the tested dose-levels,
- nor any evidence of a dose-response relationship is noted - Statistics:
- None
- Key result
- Species / strain:
- other: TA 1535, TA 100, TA 102, TA 1537 and TA 98
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: None
PRELIMINARY TOXICITY TEST
- A moderate emulsion was observed in the Petri plates when scoring the revertants at 5000 μg/plate.
- A moderate toxicity was noted at 5000 μg/plate towards the TA 98 and TA 100 strains in the absence of S9 mix (decrease in the number of revertants and/or thinning of the bacterial lawn) and in the TA 98 strain in the presence of S9 mix (decrease in the number of revertants). No noteworthy toxicity was noted in the TA 102 strain.
COMPARISON WITH HISTORICAL CONTROL DATA: Results were compared with historical data (September 01, 2013 to March 01, 2014)
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Experiments without S9 mix:
- A moderate emulsion was observed in the Petri plates when scoring the revertants at 5000 μg/plate.
- A moderate to strong toxicity was noted at dose-levels ≥ 208.3 μg/plate in the TA 1535 and TA 1537 strains, ≥ 1250 μg/plate in the TA 98 and 100 strains and at 5000 μg/plate in the TA 102 strain.
Experiments with S9 mix:
- A moderate emulsion was observed in the Petri plates when scoring the revertants at 5000 μg/plate.
- A moderate to strong toxicity was noted at dose-levels ≥ 2500 μg/plate in the TA 1535 and TA 1537 strains and at 5000 μg/plate in the TA 100 strain, in the first experiment (direct plate incorporation method).
- A moderate to strong toxicity was noted at dose-levels ≥ 625 μg/plate in the TA 1535 and TA 1537 strains, ≥ 1250 μg/plate in the TA 98 strain, ≥ 2500 μg/plate in the TA 100 strain and at 5000 μg/plate in the TA 102 strain, in the second and third experiments (pre-incubation method).
MUTAGENICITY:
Experiments without S9 mix
- The test item did not induce any noteworthy increase in the number of revertants, in any of the five tested strains, in either experiment.
Experiments with S9 mix
- A slight increase in the number of revertant colonies was noted at 312.5 μg/plate in the TA 98 strain in the second experiment (pre-incubation method). This increase reached the positive threshold of 2-fold the vehicle control value. However, the mean number of revertants remained within the historical data range of the corresponding vehicle control (45.0 versus [18-53]). Moreover, there was no clear evidence of a dose-response relationship. Since no noteworthy increase in the number of revertants was observed either in the first experiment (direct plate incorporation method) or in the third experiment using the same experimental conditions (pre-incubation method), despite the use of a narrower range of dose-levels, the slight increase noted in the second experiment was considered to be not biologically relevant.
The test item did not induce any other noteworthy increase in the number of revertants, in any other strains, in either experiment with S9 mix. - Conclusions:
- Under the test condition, test material is not mutagenic with and without metabolic activation in S. typhimurium (strains TA1535, TA1537, TA98, TA100 and TA 102).
- Executive summary:
In a reverse gene mutation assay performed according to the OECD test guideline No. 471 and in compliance with GLP, Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 were exposed to test material both in the presence and absence of metabolic activation system (10% liver S9 in standard co-factors).
Preliminary toxicity test: 10, 100, 500, 1000, 2500 and 5000 μg/plate in the TA 98, TA 100 and TA 102 strains with and without S9-mix, using plate incorporation method
First experiment (plate incorporation method):
312.5, 625, 1250, 2500 and 5000 μg/plate in the TA 98 and TA 102 strains, without S9-mix
78.1, 156.3, 312.5, 625, 1250 and 2500 μg/plate in the TA 100 strain, without S9-mix
1.3, 2.6, 7.7, 23.1, 69.4, 208.3 and 625 μg/plate in the TA 1535 and TA 1537 strains, without S9-mix
312.5, 625, 1250, 2500 and 5000 μg/plate in the TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains, with S9-mix
Second experiment:
without S9 mix (plate incorporation method):
156.3, 312.5, 625, 1250, 2500 and 5000 μg/plate in the TA 98 and TA 102 strains
78.1, 156.3, 312.5, 625, 1250, 2500 and 5000 μg/plate in the TA 100 strain
7.8, 15.6, 31.3, 62.5, 125, 250 and 500 μg/plate in the TA 1535 and TA 1537 strains
With S9 mix (pre-incubation method):
39.1, 78.1, 156.3, 312.5, 625 and 1250 μg/plate in the TA 1535 and TA 1537 strains
156.3, 312.5, 625, 1250, 2500 and 5000 μg/plate in the TA 98, TA 100 and TA 102 strains
Third experiment (pre-incubation method):
156.3, 234.4, 312.5, 468.8, 625, 1250 and 2500 μg/plate in the TA 98 strain, with S9-mix
Vehicle (DMSO) and positive control groups were also included in mutagenicity tests.
The mean number of revertants for the vehicle and positive controls met the acceptance criteria. Also, there were at least five analysable dose-levels for each strain and test condition. The study was therefore considered to be valid.
Experiments without S9 mix: A moderate emulsion was observed in the Petri plates when scoring the revertants at 5000 μg/plate. A moderate to strong toxicity was noted at dose-levels≥208.3 μg/plate in the TA 1535 and TA 1537 strains,≥1250 μg/plate in the TA 98 and 100 strains and at 5000 μg/plate in the TA 102 strain. The test item did not induce any noteworthy increase in the number of revertants, in any of the five tested strains, in either experiment.
Experiments with S9 mix: A moderate emulsion was observed in the Petri plates when scoring the revertants at 5000 μg/plate. A moderate to strong toxicity was noted at dose-levels≥2500 μg/plate in the TA 1535 and TA 1537 strains and at 5000 μg/plate in the TA 100 strain, in the first experiment (direct plate incorporation method). A moderate to strong toxicity was noted at dose-levels≥625 μg/plate in the TA 1535 and TA 1537 strains,≥1250 μg/plate in the TA 98 strain,≥2500 μg/plate in the TA 100 strain and at 5000 μg/plate in the TA 102 strain, in the second and third experiments (pre-incubation method).
A slight increase in the number of revertant colonies was noted at 312.5 μg/plate in the TA 98 strain in the second experiment (pre-incubation method). This increase reached the positive threshold of 2-fold the vehicle control value. However, the mean number of revertants remained within the historical data range of the corresponding vehicle control (45.0versus[18-53]). Moreover, there was no clear evidence of a dose-response relationship. Since no noteworthy increase in the number of revertants was observed either in the first experiment (direct plate incorporation method) or in the third experiment using the same experimental conditions (pre-incubation method), despite the use of a narrower range of dose-levels, the slight increase noted in the second experiment was considered to be not biologically relevant. The test item did not induce any other noteworthy increase in the number of revertants, in any other strains, in either experiment with S9 mix.
Under the test condition, test material is not mutagenic with and without metabolic activation in S. typhimurium (strains TA1535, TA1537, TA98, TA100 and TA 102).
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Table 7.6/1: Summary of genotoxicity test
Test n° |
Test / Guideline Reliability |
Focus |
Strains tested |
Metabolic activation |
Test concentration |
Statement |
1
Le Clere, 2015 |
Ames Test (OECD 471) K, rel. 1 |
Gene mutation |
TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA- |
-S9 +S9 |
Up to cytotoxic or highest recommended concentration |
-S9 : non mutagenic +S9 : non mutagenic |
In a reverse gene mutation assay performed according to the OECD test guideline No. 471 and in compliance with GLP, Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 were exposed to Cade oil both in the presence and absence of metabolic activation system (10% liver S9 in standard co-factors).
Preliminary toxicity test: 10, 100, 500, 1000, 2500 and 5000 μg/plate in the TA 98, TA 100 and TA 102 strains with and without S9-mix, using plate incorporation method
Vehicle (DMSO) and positive control groups were also included in mutagenicity tests.
Experiments without S9 mix: A moderate emulsion was observed in the Petri plates when scoring the revertants at 5000 μg/plate. A moderate to strong toxicity was noted at dose-levels≥208.3 μg/plate in the TA 1535 and TA 1537 strains,≥1250 μg/plate in the TA 98 and 100 strains and at 5000 μg/plate in the TA 102 strain. The test item did not induce any noteworthy increase in the number of revertants, in any of the five tested strains, in either experiment.
Experiments with S9 mix: A moderate emulsion was observed in the Petri plates when scoring the revertants at 5000 μg/plate. A moderate to strong toxicity was noted at dose-levels≥2500 μg/plate in the TA 1535 and TA 1537 strains and at 5000 μg/plate in the TA 100 strain, in the first experiment (direct plate incorporation method). A moderate to strong toxicity was noted at dose-levels≥625 μg/plate in the TA 1535 and TA 1537 strains,≥1250 μg/plate in the TA 98 strain,≥2500 μg/plate in the TA 100 strain and at 5000 μg/plate in the TA 102 strain, in the second and third experiments (pre-incubation method).
A slight increase in the number of revertant colonies was noted at 312.5 μg/plate in the TA 98 strain in the second experiment (pre-incubation method). This increase reached the positive threshold of 2-fold the vehicle control value. However, the mean number of revertants remained within the historical data range of the corresponding vehicle control (45.0 versus [18-53]). Moreover, there was no clear evidence of a dose-response relationship. Since no noteworthy increase in the number of revertants was observed either in the first experiment (direct plate incorporation method) or in the third experiment using the same experimental conditions (pre-incubation method), despite the use of a narrower range of dose-levels, the slight increase noted in the second experiment was considered to be not biologically relevant. The test item did not induce any other noteworthy increase in the number of revertants, in any other strains, in either experiment with S9 mix.
Justification for selection of
genetic toxicity endpoint
Only one study is available. The key study is GLP-compliant and of
high quality (Klimisch score =1). The result being negative, no further
tests are required for this REACH Annex VII substance.
Justification for classification or non-classification
Harmonized classification:
Cade oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the available information, no classification is proposed.
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