Registration Dossier
Registration Dossier
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EC number: 289-870-2 | CAS number: 90028-76-5 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Abies alba, Pinaceae.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
A weight of evidence approach was followed to complete this endpoint. 2 negative Ames tests (OECD guideline and GLP compliant) on two similar NCS: Juniper oil and Pine needle oil.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 16 January - 25 March 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well conducted and well described study in accordance with GLP and OECD Guideline 471 without any deviation.
- 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:
- UK GLP Compliance Programme (inspected on 10 July 2012/ signed on 30 November 2012)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine and tryptophan gene
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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 fraction prepared from liver homogenates of rats induced with Phenobarbitone/β-Naphthoflavone at 80/100 mg/kg bw/day by oral route
- Test concentrations with justification for top dose:
- Preliminary Toxicity Test (preincubation method):
- 50, 150, 500, 1500 and 5000 μg/plate in TA100 or WP2uvrA strains, presence and absence of S9- mix.
Mutation Test:
Experiment 1 (preincubation method):
- Salmonella strains TA 98 and TA 1537 (absence and presence of S9-mix), TA 100 (presence of S9-mix) and TA 1535 (absence of S9-mix): 0.0005, 0.0015, 0.005, 0.015, 0.05, 0.15 and 0.5 μg/plate.
- Salmonella strain TA 100 (absence of S9-mix): 0.0015, 0.005, 0.015, 0.05, 0.15, 0.5 and 1.5 μg/plate.
- Salmonella strain TA 1535 (presence of S9-mix): 0.005, 0.015, 0.05, 0.15, 0.5, 1.5 and 5 μg/plate.
- E.coli strain WP2uvrA (absence and presence of S9-mix): 0.05, 0.15, 0.5, 1.5, 5, 15 and 50 μg/plate.
Experiment 2 (preincubation method):
- Salmonella strains TA 98, TA 1535 and TA 1537 (absence of S9-mix) and TA 100 (presence and absence of S9-mix): 0.0015, 0.005, 0.015, 0.05, 0.15, 0.5 and 1.5 μg/plate.
- Salmonella strains TA 98 and TA 1537 (presence of S9-mix): 0.0005, 0.0015, 0.005, 0.015, 0.05, 0.15 and 0.5 μg/plate.
- Salmonella strain TA 1535 (presence of S9-mix): 0.005, 0.015, 0.05, 0.15, 0.5, 1.5 and 5 μg/plate.
- E.coli strain WP2uvrA (absence and presence of S9-mix): 0.05, 0.15, 0.5, 1.5, 5, 15 and 50 μg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tetrahydrofuran
- Justification for choice of solvent/vehicle: Test item was immiscible in sterile distilled water, dimethyl sulphoxide, dimethyl formamide at 50 mg/mL and acetone at 100 mg/mL but was fully miscible in tetrahydrofuran at 200 mg/mL in solubility checks performed in-house. Tetrahydrofuran was therefore selected as the vehicle.
- Formulation preparation: Test item was accurately weighed and approximate half-log dilutions prepared in tetrahydrofuran by mixing on a vortex mixer on the day of each experiment. All formulations were used within four hours of preparation and were assumed to be stable for this period. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tetrahydrofuran
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tetrahydrofuran
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM: All strains of bacteria used in the test were obtained from the University of California, Berkeley, on culture discs, on 04 August 1995 or from the British Industrial Biological Research Association, on nutrient agar plates, on 17 August 1987.
METHOD OF APPLICATION: Preincubation (test item, vehicle and positive controls) and plate incorporation (negative control) methods
DURATION
- Preincubation period: 20 minutes at 37 °C with shaking at approximately 130 rpm
- Incubation period: Treated plates were placed in anaerobic jars or bags (one jar/bag for each concentration of test item/vehicle) and incubated at 37 °C for approximately 48 h.
NUMBER OF REPLICATIONS:
-1 plate/dose for preliminary toxicity test and 3 plates/dose for treatment, negative, vehicle and positive controls in mutation test (Experiment 1 & 2).
DETERMINATION OF CYTOTOXICITY
- Method: Toxicity was determined on the basis of growth of the bacterial background lawn.
OTHER: After approximately 48 h incubation at 37 °C the plates were assessed for numbers of revertant colonies using an automated colony counter. - Evaluation criteria:
- There are several criteria for determining a positive result. Any one, or all of the following can be used to determine the overall result of the study:
- A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby (1979)).
- A reproducible increase at one or more concentrations.
- Biological relevance against in-house historical control ranges.
- Statistical analysis of data as determined by UKEMS (Mahon et al (1989)).
- Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgement about test item activity. Results of this type will be reported as equivocal. - Statistics:
- Statistical analysis of data as determined by UKEMS (Mahon et al (1989)).
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test item precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
PRELIMINARY TOXICITY TEST:
- The test item initially exhibited toxicity to TA 100 from 50 µg/plate and 1500 µg/plate to WP2uvrA.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Mutation Test: The test item caused a visible reduction in the growth of the bacterial background lawns of all of the Salmonella tester strains, initially from 0.15 µg/plate in both the absence and presence of S9-mix. The test item also induced toxicity to Escherichia coli strain WP2uvrA, initially from 15 µg/plate in the absence of S9-mix and 50 µg/plate in the presence of S9-mix. The sensitivity of the tester strains to the toxicity of the test item varied both between strain type, exposures with or without S9-mix and experiment number.
COMPARISON WITH HISTORICAL CONTROL DATA:
- Results were compared with historical negative, solvent and positive control data (2010 and 2011) and lies within the range.
OTHERS:
- Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory). The amino acid supplemented top agar and S9-mix used in both experiments was shown to be sterile.
- The culture density for each bacterial strain was also checked and considered acceptable.
- Test item formulation used in this experiment was shown to be sterile. - Conclusions:
- Under the test condition, Juniper oil is not mutagenic with and without metabolic activation to strains of S. typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and E. coli WP2 uvr A.
- Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and Escherichia coli (WP2uvrA) were exposed to Juniper oil at the following concentrations under anaerobic conditions:
Preliminary Toxicity Test (preincubation method):
- 50, 150, 500, 1500 and 5000 μg/plate in TA100 or WP2uvrA strains, presence and absence of S9- mix.
Mutation Test:
Experiment 1 (preincubation method):
-Salmonella strains TA 98 and TA 1537 (absence and presence of S9-mix), TA 100 (presence of S9-mix) and TA 1535 (absence of S9-mix): 0.0005, 0.0015, 0.005, 0.015, 0.05, 0.15 and 0.5 μg/plate.
-Salmonella strain TA 100 (absence of S9-mix): 0.0015, 0.005, 0.015, 0.05, 0.15, 0.5 and 1.5 μg/plate.
-Salmonella strain TA 1535 (presence of S9-mix): 0.005, 0.015, 0.05, 0.15, 0.5, 1.5 and 5 μg/plate.
-E.coli strain WP2uvrA (absence and presence of S9-mix): 0.05, 0.15, 0.5, 1.5, 5, 15 and 50 μg/plate.
Experiment 2 (preincubation method):
-Salmonella strains TA 98, TA 1535 and TA 1537 (absence of S9-mix) and TA 100 (presence and absence of S9-mix): 0.0015, 0.005, 0.015, 0.05, 0.15, 0.5 and 1.5 μg/plate.
-Salmonella strains TA 98 and TA 1537 (presence of S9-mix): 0.0005, 0.0015, 0.005, 0.015, 0.05, 0.15 and 0.5 μg/plate.
-Salmonella strain TA 1535 (presence of S9-mix): 0.005, 0.015, 0.05, 0.15, 0.5, 1.5 and 5 μg/plate.
-E.coli strain WP2uvrA (absence and presence of S9-mix): 0.05, 0.15, 0.5, 1.5, 5, 15 and 50 μg/plate.
Metabolic activation system used in this test was10 % S9; S9 fraction prepared from liver homogenates of rats induced with Phenobarbitone/β-Naphthoflavone. Negative, vehicle and positive control groups were also included in mutagenicity tests.
In preliminary toxicity test, the test item initially exhibited toxicity to TA 100 from 50 µg/plate and 1500 µg/plate to WP2uvrA. In main experiments, the test item caused a visible reduction in the growth of the bacterial background lawns of all of the Salmonella tester strains, initially from 0.15 µg/plate in both the absence and presence of S9-mix. The test item also induced toxicity to Escherichia coli strain WP2uvrA, initially from 15 µg/plate in the absence of S9-mix and 50 µg/plate in the presence of S9-mix. The sensitivity of the tester strains to the toxicity of the test item varied both between strain type, exposures with or without S9-mix and experiment number. No test item precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix. No biologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation. Small, statistically significant increases in TA 98 revertant colony frequency were observed in Experiment 2 at 0.0005, 0.0015, 0.015 and 0.5 µg/plate in the absence of S9-mix only. These increases were considered to be of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the individual revertant counts at the statistically significant dose levels were within the in-house historical untreated/vehicle control range for the tester strain and the maximum fold increase was only 1.6 times the concurrent vehicle control.The positive and vehicle controls induced the appropriate responses in the corresponding strains indicating the validity of the study.
Under the test conditions, Juniper oil is not considered as mutagenic in these bacterial systems.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 16 January - 26 March 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well conducted and well described study in accordance with GLP and OECD Guideline 471 without any deviation. This study was performed on a similar compositional NCS than the one to be registered.
- 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:
- UK GLP Compliance Programme (inspected on 10 July 2012/ signed on 30 November 2012)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine and tryptophan gene
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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 fraction prepared from liver homogenates of rats induced with Phenobarbitone/β-Naphthoflavone at 80/100 mg/kg bw/day by oral route
- Test concentrations with justification for top dose:
- Preliminary Toxicity Test (preincubation method):
- 50, 150, 500, 1500 and 5000 μg/plate in TA100 or WP2uvrA strains, presence and absence of S9- mix. As toxicity was observed from 50 µg/plate a second preliminary test was performed.
- 0.015, 0.05, 0.15, 0.5, 1.5, 5, 15 and 50 μg/plate in TA100 or WP2uvrA strains, presence and absence of S9- mix.
Mutation Test:
Experiment 1 (preincubation method):
- All Salmonella strains (absence of S9-mix): 0.15, 0.5, 1.5, 5, 15, 50 and 150 µg/plate.
- WP2uvrA (absence of S9-mix): 0.05, 0.15, 0.5, 1.5, 5, 15 and 50 µg/plate.
- All tester strains (presence of S9-rnix): 0.5, 1.5, 5, 15, 50, 150 and 500 µg/plate.
Experiment 2 (preincubation method):
- All tester strains (presence of S9 mix): 0.5, 1.5, 5, 15, 50, 150 and 500 µg/plate.
- All tester strains (absence of S9-mix): 0.05, 0.15, 0.5, 1.5, 5, 15 and 50 µg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: Test item was immiscible in sterile distilled water and dimethyl sulphoxide at 50 mg/mL but was fully miscible in acetone at 100 mg/mL in solubility checks performed in-house. Acetone was therefore selected as the vehicle.
- Formulation preparation: Test item was accurately weighed and approximate half-log dilutions prepared in acetone by mixing on a vortex mixer on the day of each experiment. All formulations were used within four hours of preparation and were assumed to be stable for this period. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM: All strains of bacteria used in the test were obtained from the University of California, Berkeley, on culture discs, on 04 August 1995 or from the British Industrial Biological Research Association, on nutrient agar plates, on 17 August 1987.
METHOD OF APPLICATION: Preincubation (test item, vehicle and positive controls) and plate incorporation (negative control) methods
DURATION
- Preincubation period: 20 minutes at 37 °C with shaking at approximately 130 rpm
- Incubation period: Treated plates were placed in anaerobic jars or bags (one jar/bag for each concentration of test item/vehicle) and incubated at 37 °C for approximately 48 h.
NUMBER OF REPLICATIONS:
-1 plate/dose for preliminary toxicity test and 3 plates/dose for treatment, negative, vehicle and positive controls in mutation test (Experiment 1 & 2).
DETERMINATION OF CYTOTOXICITY
- Method: Toxicity was determined on the basis of growth of the bacterial background lawn.
OTHER: After approximately 48 h incubation at 37 °C the plates were assessed for numbers of revertant colonies using an automated colony counter. - Evaluation criteria:
- There are several criteria for determining a positive result. Any one, or all of the following can be used to determine the overall result of the study:
- A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby (1979)).
- A reproducible increase at one or more concentrations.
- Biological relevance against in-house historical control ranges.
- Statistical analysis of data as determined by UKEMS (Mahon et al (1989)).
- Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgement about test item activity. Results of this type will be reported as equivocal. - Statistics:
- Statistical analysis of data as determined by UKEMS (Mahon et al (1989)).
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: A light, globular test item precipitate was observed at 5000 µg/plate. Due to the toxicity of the test item this observation was only noted in the preliminary toxicity test.
PRELIMINARY TOXICITY TEST:
- The test item initially exhibited toxicity to the strains of bacteria (TA 100 and WP2uvrA) from 15 and 150 µg/plate in the absence and presence of S9-mix respectively.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Mutation Test: The test item caused a visible reduction in the growth of the bacterial background lawns of all of the tester strains, initially from 15 µg/plate in the absence of S9-mix and 150 µg/plate in the presence of S9-mix. The sensitivity of the tester strains to the toxicity of the test item varied slightly between strain type and exposures with or without S9-mix.
COMPARISON WITH HISTORICAL CONTROL DATA:
- Results were compared with historical negative, solvent and positive control data (2010 and 2011) and lies within the range.
OTHERS:
- Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory). The amino acid supplemented top agar and S9-mix used in both experiments was shown to be sterile.
- The culture density for each bacterial strain was also checked and considered acceptable.
- Test item formulation used in this experiment was shown to be sterile. - Conclusions:
- Under the test condition, Pine needle oil is not mutagenic with and without metabolic activation to strains of S. typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and E. coli WP2 uvr A.
- Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and Escherichia coli (WP2uvrA) were exposed to Pine needle oil at the following concentrations:
Preliminary Toxicity Test (preincubation method):
- 50, 150, 500, 1500 and 5000 μg/plate in TA100 or WP2uvrA strains, presence and absence of S9- mix. As toxicity was observed from 50 µg/plate a second preliminary test was performed.
- 0.015, 0.05, 0.15, 0.5, 1.5, 5, 15 and 50 μg/plate in TA100 or WP2uvrA strains, presence and absence of S9- mix.
Mutation Test:
Experiment 1 (preincubation method):
- All Salmonella strains (absence of S9-mix): 0.15, 0.5, 1.5, 5, 15, 50 and 150 µg/plate.
- WP2uvrA (absence of S9-mix): 0.05, 0.15, 0.5, 1.5, 5, 15 and 50 µg/plate.
- All tester strains (presence of S9-rnix): 0.5, 1.5, 5, 15, 50, 150 and 500 µg/plate.
Experiment 2 (preincubation method):
- All tester strains (presence of S9 mix): 0.5, 1.5, 5, 15, 50, 150 and 500 µg/plate.
- All tester strains (absence of S9-mix): 0.05, 0.15, 0.5, 1.5, 5, 15 and 50 µg/plate.Metabolic activation system used in this test was10 % S9; S9 fraction prepared from liver homogenates of rats induced with Phenobarbitone/β-Naphthoflavone. Negative, vehicle and positive control groups were also included in mutagenicity tests.
In preliminary toxicity test, the test item initially exhibited toxicity to the strains of bacteria (TA 100 and WP2uvrA) from 15 and 150 µg/plate in the absence and presence of S9-mix respectively. In main experiments, the test item caused a visible reduction in the growth of the bacterial background lawns of all of the tester strains, initially from 15 µg/plate in the absence of S9-mix and 150 µg/plate in the presence of S9-mix. The sensitivity of the tester strains to the toxicity of the test item varied slightly between strain type and exposures with or without S9-mix. A light, globular test item precipitate was observed at 5000 µg/plate. Due to the toxicity of the test item this observation was only noted in the preliminary toxicity test. No toxicologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation. A small, statistically significant increase in TA 98 revertant colony frequency was observed in the absence of S9-mix at 1.5 µg/plate in Experiment 1. This increase was considered to be of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the individual revertant colony counts at 1.5 µg/plate were within the in-house historical untreated/vehicle control range for the tester strain and the fold increase was only 1.70 times the concurrent vehicle control. The positive and vehicle controls induced the appropriate responses in the corresponding strains indicating the validity of the study.
Under the test conditions, Pine needle oil is not considered as mutagenic in these bacterial systems.
Referenceopen allclose all
Table 7.6.1/3: Preliminary Toxicity Test : number of revertants depending on the tested concentration
With (+) or without (-) S9-mix |
Strain
|
Dose (µg/plate) |
|||||
0 |
50 |
150 |
500 |
1500 |
5000 |
||
- |
TA 100 |
124 |
82 S |
76 V |
83 V |
0 V |
0 V |
+ |
TA 100 |
95 |
86 S |
89 S |
73 S |
0 V |
0 V |
- |
WP2 uvr A |
30 |
26 |
24 |
30 |
30 S |
28 S |
+ |
WP2 uvr A |
29 |
24 |
25 |
27 |
29 S |
41 S |
S: sparse bacterial background lawn
V: Very weak bacterial background lawn
See the attached Document for information on tables of results - Main experiments
Table 7.6.1/3: Preliminary Toxicity Test : number of revertants depending on the tested concentration
With (+) or without (-) S9-mix |
Strain |
Dose (µg/plate) |
||||||||||||
0 |
0.015 |
0.05 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
||
- |
TA 100 |
94 |
80 |
101 |
83 |
90 |
93 |
75 |
76 |
50V |
N/T |
N/T |
N/T |
N/T |
+ |
TA 100 |
90 |
N/T |
N/T |
N/T |
N/T |
N/T |
N/T |
N/T |
87 |
57 S |
63 S |
49 S |
59 VP |
- |
WP2 uvr A |
17 |
19 |
17 |
14 |
11 |
16 |
16 |
15 S |
8 S |
N/T |
N/T |
N/T |
N/T |
+ |
WP2 uvr A |
26 |
N/T |
N/T |
N/T |
N/T |
N/T |
N/T |
N/T |
20 |
17 S |
27 S |
12 S |
13 SP |
S: Sparse bacterial background lawn
V: Very weak bacterial background lawn
N/T: Assay repeated and not tested at this dose level due to toxicity
P: Precipitate
See the attached Document for information on tables of results - Main experiments
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Two Ames tests were available on two NCS that are similar regarding their composition to the registered substance (Fir silver oil). The composition of Fir silver oil is covered by the composition of Pine needle and Juniper oils. Therefore both studies were used as a weight of evidence to complete the genetic toxicity endpoint.
Both tests gave negative results with and without metabolic activation.
Therefore Fir silver oil is not considered as genotoxic in bacteria systems.
Justification for classification or non-classification
Harmonized classification:
Fir silver oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the data available, Fir silver oil is not classified as genotoxic according to the Regulation (EC) No. 1272/2008 and to the GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
