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EC number: 232-350-7 | CAS number: 8006-64-2 Any of the volatile predominately terpenic fractions or distillates resulting from the solvent extraction of, gum collection from, or pulping of softwoods. Composed primarily of the C10H16 terpene hydrocarbons: α-pinene, β-pinene, limonene, 3-carene, camphene. May contain other acyclic, monocyclic, or bicyclic terpenes, oxygenated terpenes, and anethole. Exact composition varies with refining methods and the age, location, and species of the softwood source.
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: EPA (TSCA) OPPTS harmonised guidelines
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Turpentine, oil
- EC Number:
- 232-350-7
- EC Name:
- Turpentine, oil
- Cas Number:
- 8006-64-2
- Molecular formula:
- UVCB substance molecular formula varied but mainly C10H16, C15H24, C2H6S1, C1H4S1 and C10H18O1
- IUPAC Name:
- Turpentine oil from pulping processes
Constituent 1
Method
- Target gene:
- histidine (Salmonella); tryptophan (E. coli)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbitone/beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 5-5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the test material was insoluble in water but fully soluble in DMSO at 50 mg/ml
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without metabolic activation for: E. coli (2 µg/plate), TA 100 (3 µg/plate), TA 1535 (5 µg/plate)
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation for: TA 1537 (80 µg/plate)
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without metabolic activation for TA 98 (0.2 µg/plate)
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation for: TA 100 (1 µg/plate), TA 1535 and TA 1537 (2 µg/plate), E. coli (10 µg/plate)
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation for TA 98 (5 µg/plate)
- Details on test system and experimental conditions:
- ACTIVATION: Phenobarbitol/beta-naphthoflavone induced rat liver S9: 10% in S9 mix including NADP and glucose-6-phosphate. 0.5 ml of S9 mix added to 2 ml agar, 0.1 ml bacterial culture and 0.1 ml test substance before pouring plates.
METHOD OF APPLICATION: in agar (plate incorporation); preincubation;
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
SELECTION AGENT (mutation assays): histidine deficient agar
NUMBER OF REPLICATIONS: triplicate plates; experiment repeated: Experiment 1 plate incorporation; Experiment 2 preincubation
DETERMINATION OF CYTOTOXICITY
- Method: other: reduction in background lawn; reduction in number of revertants per plate - Evaluation criteria:
- A substance is considered positive if it induces a dose-related increase in revertant frequency over the dose range and/or a reproducible increase at one or more concentration in at least one bacterial strain with or without metabolic activation.
- Statistics:
- Statistical evaluation used as aid to evaluation if necessary.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 500 µg/plate (preincubation, with metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 500 µg/plate (preincubation, with metabolic activation)
- Vehicle controls validity:
- valid
- 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:
- cytotoxicity
- Remarks:
- 500 µg/plate (preincubation, with metabolic activation)
- Vehicle controls validity:
- valid
- 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:
- cytotoxicity
- Remarks:
- 500 µg/plate (preincubation, with metabolic activation)
- Vehicle controls validity:
- valid
- 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:
- cytotoxicity
- Remarks:
- 500 µg/plate (preincubation, with metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no information
- Effects of osmolality: no information
- Evaporation from medium: no information
- Water solubility: not soluble in water
- Precipitation: none recorded
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: Slight thinning of background lawn was observed in range-finding study
COMPARISON WITH HISTORICAL CONTROL DATA: results were within the historical control values
ADDITIONAL INFORMATION ON CYTOTOXICITY: Experiment 1: slight thinning of bacterial background lawn was observed in all tester strains with and without metabolic activation, initially at 500 µg/plate. Experiment 2: reduction in bacterial background lawn at 15 µg/plate in absence of metabolic activation, and at 500 µg/plate with metabolic activation. - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table 1 Experiment 1 Plate incorporation: Number of revertants per plate (mean of 3 plates)
Concentration µg/plate |
TA 100 |
TA 1535 |
E. coli SP2uvrA |
TA 98 |
TA 1537 |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
0*** |
110 |
93 |
19 |
14 |
16 |
19 |
18 |
26 |
5 |
9 |
5 |
111 |
96 |
21 |
14 |
NT |
NT |
21 |
26 |
5 |
4 |
15 |
108 |
87 |
19 |
9 |
18 |
20 |
13 |
21 |
9 |
8 |
50 |
100 |
100 |
20 |
14 |
20 |
27 |
25 |
25 |
6 |
9 |
150 |
121 |
91 |
12 |
8 |
19 |
23 |
20 |
26 |
4 |
7 |
500 |
127 |
106 |
25 |
12 |
21 |
25 |
17 |
23 |
11* |
8* |
1500 |
124* |
113* |
27* |
22* |
23 |
18 |
15* |
28 |
7** |
9** |
5000 |
133* |
92* |
32* |
20* |
23 |
15 |
15* |
20* |
7** |
9** |
Positive control |
730 |
1250 |
606 |
254 |
655 |
333 |
152 |
178 |
737 |
215 |
* Sparse bacterial lawn
** Very sparse bacterial lawn
*** Solvent control with DMSO
NT not tested
Table 2a Experiment 2 Pre-incubation: Number of revertants per plate (mean of 3 plates)
Concentration µg/plate |
TA 100 |
TA 1535 |
TA 98 |
TA 1537 |
Concentration µg/plate |
TA 100 |
TA 1535 |
E. coli WP2uvrA |
TA 98 |
TA 1537 |
- MA |
- MA |
- MA |
- MA |
+ MA |
+ MA |
+ MA |
+ MA |
+ MA |
||
0*** |
112 |
19 |
19 |
13 |
0*** |
98 |
11 |
43 |
24 |
9 |
0.05 |
109 |
17 |
20 |
11 |
1.5 |
87 |
10 |
NT |
26 |
10 |
0.15 |
103 |
21 |
18 |
9 |
5 |
88 |
13 |
NT |
27 |
11 |
0.5 |
99 |
22 |
19 |
11 |
15 |
79 |
10 |
42 |
25 |
9 |
1.5 |
107 |
18 |
19 |
11 |
50 |
91 |
9 |
38 |
21 |
11 |
5 |
104 |
21 |
18 |
13 |
150 |
84 |
10 |
31 |
22 |
8 |
15 |
96* |
22* |
15* |
9* |
500 |
0** |
10* |
34 |
20 |
10* |
50 |
93* |
22* |
11* |
4* |
1500 |
0** |
0** |
33 |
0 |
1** |
- |
- |
- |
- |
- |
5000 |
NT |
NT |
33* |
NT |
NT |
Positive control |
489 |
1719 |
139 |
769 |
Positive control |
1017 |
287 |
341 |
360 |
314 |
* Sparse bacterial lawn
** Very sparse bacterial lawn
*** Solvent control with DMSO
NT not tested
Table 2b Experiment 2 Pre-incubation: Number of revertants per plate (mean of 3 plates)
Concentration µl/plate |
E. coli WP2uvrA |
- MA |
|
0*** |
337 |
15 |
31 |
50 |
30 |
150 |
29 |
500 |
34 |
1500 |
31* |
5000 |
24* |
Positive control |
1027 |
* Sparse bacterial lawn
*** Solvent control with DMSO
Applicant's summary and conclusion
- Conclusions:
- Turpentine oil has been tested according to OECD 471 and under GLP. No increase in the number of revertants per plate was observed in any of the bacterial strains used when tested with and without metabolic activation using the plate incorporation method. The results were confirmed in the repeat assay using the preincubation method. Positive and solvent controls gave the expected results. It is concluded that turpentine oil is negative for mutagenicity to bacteria under the conditions of the test.
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