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Registration Dossier
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EC number: 203-892-1 | CAS number: 111-65-9
- 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
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- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1982-1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1982-1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- 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:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The purpose of this study was to determine the mutagenicity of the test substance Normal-Heptane. A reverse mutation assay was done using S. typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100, and E. coli strains WP2 and WP2 uvr A. The strains were exposed to concentrations of 0, 3.91, 7.81, 15.6, 31.3, 62.5, 125, and 250 ug/mL for 48 -72 hrs both with and without metabolic activation. The number of revertant colonies was then counted.
No significant increases in the ratio of mutations over controls was seen. The test substance is not mutagenic in either the presence or absence of metabolic activation. - Executive summary:
This data is being read across from the source study that tested Heptane based on analogue read across.
The purpose of this study was to determine the mutagenicity of the test substance Normal-Heptane. A reverse mutation assay was done using S. typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100, and E. coli strains WP2 and WP2 uvr A. The strains were exposed to concentrations of 0, 3.91, 7.81, 15.6, 31.3, 62.5, 125, and 250 ug/mL for 48 -72 hrs both with and without metabolic activation. The number of revertant colonies was then counted.
No significant increases in the ratio of mutations over controls was seen. The test substance is not mutagenic in either the presence or absence of metabolic activation.
The addition of heptane at amounts up to 250 µg per mL to cultures of Escherichia coli WP2 and WP2 uvr A, Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, and TA 100 did not lead to an increase in the reverse gene mutation frequency in any of these strains, either in the presence or in the absence of rat liver S9 fraction.
Table: Relative Reverse Mutation Rate – E. coli
Concentration (µg/ml) |
E. coliWP2 Assay 1 |
E. coliWP2 Assay 2 |
E. coliWP2 Assay 3 |
E. coliWP2 uvr A Assay 1 |
E. coliWP2 uvr A Assay 2 |
Without S9 |
|||||
3.91 |
- |
1.6 |
0.9 |
- |
0.9 |
7.81 |
- |
2.3 |
1.0 |
- |
0.9 |
15.6 |
1.2 |
1.3 |
0.8 |
0.5 |
0.8 |
31.3 |
1.1 |
1.4 |
0.7 |
0.8 |
0.6 |
62.5 |
1.0 |
1.0 |
0.8 |
0.9 |
0.5 |
125 |
0.7 |
0.6 |
1.2 |
0.3 |
0.5 |
250 |
0.5 |
0.8 |
1.0 |
0.2 |
0.5 |
4-nitroquinoline-N-oxide |
31.7 |
7.7 |
4.8 |
1.9 |
6.3 |
With S9 |
|||||
3.91 |
- |
1.5 |
0.9 |
- |
1.0 |
7.81 |
- |
2.4 |
0.9 |
- |
1.4 |
15.6 |
0.7 |
3.1 |
1.0 |
1.8 |
0.9 |
31.3 |
0.7 |
2.8 |
0.8 |
0.8 |
0.9 |
62.5 |
1.0 |
2.4 |
0.6 |
1.0 |
0.9 |
125 |
0.9 |
2.2 |
1.1 |
2.0 |
0.9 |
250 |
0.7 |
1.3 |
0.9 |
- |
0.8 |
4-nitroquinoline-N-oxide |
1.0 |
3.9 |
0.7 |
9.0 |
19.7 |
Table: Relative Mutation Rate – S. typhimurium TA 1535, TA 1537, TA 1538
Concentration (µg/ml) |
TA 1535 Assay 1 |
TA 1535 Assay 2 |
TA 1537 Assay 1 |
TA 1537 Assay 2 |
TA 1538 Assay 1 |
TA 1538 Assay 2 |
TA 1538 Assay 3 |
Without S9 |
|||||||
3.91 |
- |
- |
- |
- |
- |
- |
- |
7.81 |
- |
1.2 |
- |
0.7 |
- |
0.8 |
1.0 |
15.6 |
1.6 |
1.2 |
1.3 |
0 |
0.5 |
1.0 |
1.0 |
31.3 |
0.1 |
0.6 |
0.4 |
0 |
0 |
0.4 |
0.7 |
62.5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
125 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
250 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Sodium azide 1.7 µg |
48.0 |
73.1 |
- |
- |
- |
- |
- |
Benzo(a)-pyrene 6.7 µg |
- |
- |
- |
- |
1.4 |
1.1 |
0.9 |
Neutral red 6.7 µg |
- |
- |
1.5 |
1.6 |
- |
- |
- |
With S9 |
|||||||
3.91 |
- |
- |
- |
- |
- |
- |
- |
7.81 |
- |
0.9 |
- |
0.7 |
- |
- |
0.8 |
15.6 |
2.1 |
1.0 |
2.4 |
0.7 |
1.5 |
- |
1.0 |
31.3 |
1.4 |
0.9 |
1.3 |
0.9 |
2.1 |
- |
0.7 |
62.5 |
1.7 |
0.6 |
1.8 |
0.9 |
1.8 |
- |
1.0 |
125 |
1.7 |
1.3 |
2.1 |
0.6 |
1.2 |
- |
1.1 |
250 |
1.1 |
0.7 |
2.3 |
0.8 |
1.3 |
- |
0.9 |
Sodium azide 1.7 µg |
19.3 |
78.3 |
- |
- |
- |
- |
- |
Benzo(a)-pyrene 6.7 µg |
- |
- |
- |
- |
2.4 |
- |
10.6 |
Neutral red 6.7 µg |
- |
- |
3.0 |
6.0 |
- |
- |
- |
Table: Relative Mutation Rate – S. typhimurium TA 98, TA 100
Concentration (µg/ml) |
TA 98 Assay 1 |
TA 98 Assay 2 |
TA 100 Assay 1 |
TA 100 Assay 2 |
Without S9 |
||||
3.91 |
- |
0.5 |
- |
1.1 |
7.81 |
- |
0.1 |
- |
1.0 |
15.6 |
0.6 |
0 |
1.1 |
0.8 |
31.3 |
0 |
0 |
1.1 |
0.1 |
62.5 |
0 |
0 |
1.0 |
0 |
125 |
0 |
0 |
1.2 |
0 |
250 |
0 |
0 |
0.6 |
0 |
Benzo(a)-pyrene 6.7 µg |
0.8 |
1.2 |
1.6 |
1.0 |
With S9 |
||||
3.91 |
- |
0.8 |
- |
1.0 |
7.81 |
- |
1.1 |
- |
0.9 |
15.6 |
0.9 |
1.1 |
0.9 |
1.0 |
31.3 |
0.9 |
1.0 |
0.8 |
1.1 |
62.5 |
0.8 |
0.9 |
0.7 |
0.9 |
125 |
0.7 |
0.8 |
0.9 |
1.2 |
250 |
0.4 |
0.5 |
0.9 |
0.9 |
Benzo(a)-pyrene 6.7 µg |
12.6 |
4.7 |
2.8 |
5.4 |
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1982
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- No specific method or guideline was noted; similar to OECD guideline 471; limited documentation
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Heptane
- EC Number:
- 205-563-8
- EC Name:
- Heptane
- Cas Number:
- 142-82-5
- Molecular formula:
- C7H16
- IUPAC Name:
- Heptane
- Details on test material:
- - Name of test material (as cited in study report): Heptane
- Analytical purity: 100% pure commercial product
Constituent 1
Method
- Target gene:
- His-operon (Salmonellla), Trp-operon (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix of livers from Aroclor1254-pretreated rats
- Test concentrations with justification for top dose:
- max. conc. tested: 250 µg/mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween80/ethanol
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: benzo[a]pyrene in DMSO, 4-nitroquinoline-N-oxide in DMSO, sodium azide, neutral red, potassium dichromate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: no data
- Exposure duration: not applicable, preincubation method
- Expression time (cells in growth medium): 48-72 hours
DETERMINATION OF CYTOTOXICITY
- Method: other: toxicity screening test
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:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- 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:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The addition of heptane at amounts up to 250 µg per mL to cultures of Escherichia coli WP2 and WP2 uvr A, Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, and TA 100 did not lead to an increase in the reverse gene mutation frequency in any of these strains, either in the presence or in the absence of rat liver S9 fraction.
Table: Relative Reverse Mutation Rate – E. coli
Concentration (µg/ml) |
E. coliWP2 Assay 1 |
E. coliWP2 Assay 2 |
E. coliWP2 Assay 3 |
E. coliWP2 uvr A Assay 1 |
E. coliWP2 uvr A Assay 2 |
Without S9 |
|||||
3.91 |
- |
1.6 |
0.9 |
- |
0.9 |
7.81 |
- |
2.3 |
1.0 |
- |
0.9 |
15.6 |
1.2 |
1.3 |
0.8 |
0.5 |
0.8 |
31.3 |
1.1 |
1.4 |
0.7 |
0.8 |
0.6 |
62.5 |
1.0 |
1.0 |
0.8 |
0.9 |
0.5 |
125 |
0.7 |
0.6 |
1.2 |
0.3 |
0.5 |
250 |
0.5 |
0.8 |
1.0 |
0.2 |
0.5 |
4-nitroquinoline-N-oxide |
31.7 |
7.7 |
4.8 |
1.9 |
6.3 |
With S9 |
|||||
3.91 |
- |
1.5 |
0.9 |
- |
1.0 |
7.81 |
- |
2.4 |
0.9 |
- |
1.4 |
15.6 |
0.7 |
3.1 |
1.0 |
1.8 |
0.9 |
31.3 |
0.7 |
2.8 |
0.8 |
0.8 |
0.9 |
62.5 |
1.0 |
2.4 |
0.6 |
1.0 |
0.9 |
125 |
0.9 |
2.2 |
1.1 |
2.0 |
0.9 |
250 |
0.7 |
1.3 |
0.9 |
- |
0.8 |
4-nitroquinoline-N-oxide |
1.0 |
3.9 |
0.7 |
9.0 |
19.7 |
Table: Relative Mutation Rate – S. typhimurium TA 1535, TA 1537, TA 1538
Concentration (µg/ml) |
TA 1535 Assay 1 |
TA 1535 Assay 2 |
TA 1537 Assay 1 |
TA 1537 Assay 2 |
TA 1538 Assay 1 |
TA 1538 Assay 2 |
TA 1538 Assay 3 |
Without S9 |
|||||||
3.91 |
- |
- |
- |
- |
- |
- |
- |
7.81 |
- |
1.2 |
- |
0.7 |
- |
0.8 |
1.0 |
15.6 |
1.6 |
1.2 |
1.3 |
0 |
0.5 |
1.0 |
1.0 |
31.3 |
0.1 |
0.6 |
0.4 |
0 |
0 |
0.4 |
0.7 |
62.5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
125 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
250 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Sodium azide 1.7 µg |
48.0 |
73.1 |
- |
- |
- |
- |
- |
Benzo(a)-pyrene 6.7 µg |
- |
- |
- |
- |
1.4 |
1.1 |
0.9 |
Neutral red 6.7 µg |
- |
- |
1.5 |
1.6 |
- |
- |
- |
With S9 |
|||||||
3.91 |
- |
- |
- |
- |
- |
- |
- |
7.81 |
- |
0.9 |
- |
0.7 |
- |
- |
0.8 |
15.6 |
2.1 |
1.0 |
2.4 |
0.7 |
1.5 |
- |
1.0 |
31.3 |
1.4 |
0.9 |
1.3 |
0.9 |
2.1 |
- |
0.7 |
62.5 |
1.7 |
0.6 |
1.8 |
0.9 |
1.8 |
- |
1.0 |
125 |
1.7 |
1.3 |
2.1 |
0.6 |
1.2 |
- |
1.1 |
250 |
1.1 |
0.7 |
2.3 |
0.8 |
1.3 |
- |
0.9 |
Sodium azide 1.7 µg |
19.3 |
78.3 |
- |
- |
- |
- |
- |
Benzo(a)-pyrene 6.7 µg |
- |
- |
- |
- |
2.4 |
- |
10.6 |
Neutral red 6.7 µg |
- |
- |
3.0 |
6.0 |
- |
- |
- |
Table: Relative Mutation Rate – S. typhimurium TA 98, TA 100
Concentration (µg/ml) |
TA 98 Assay 1 |
TA 98 Assay 2 |
TA 100 Assay 1 |
TA 100 Assay 2 |
Without S9 |
||||
3.91 |
- |
0.5 |
- |
1.1 |
7.81 |
- |
0.1 |
- |
1.0 |
15.6 |
0.6 |
0 |
1.1 |
0.8 |
31.3 |
0 |
0 |
1.1 |
0.1 |
62.5 |
0 |
0 |
1.0 |
0 |
125 |
0 |
0 |
1.2 |
0 |
250 |
0 |
0 |
0.6 |
0 |
Benzo(a)-pyrene 6.7 µg |
0.8 |
1.2 |
1.6 |
1.0 |
With S9 |
||||
3.91 |
- |
0.8 |
- |
1.0 |
7.81 |
- |
1.1 |
- |
0.9 |
15.6 |
0.9 |
1.1 |
0.9 |
1.0 |
31.3 |
0.9 |
1.0 |
0.8 |
1.1 |
62.5 |
0.8 |
0.9 |
0.7 |
0.9 |
125 |
0.7 |
0.8 |
0.9 |
1.2 |
250 |
0.4 |
0.5 |
0.9 |
0.9 |
Benzo(a)-pyrene 6.7 µg |
12.6 |
4.7 |
2.8 |
5.4 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The purpose of this study was to determine the mutagenicity of the test substance Normal-Heptane. A reverse mutation assay was done using S. typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100, and E. coli strains WP2 and WP2 uvr A. The strains were exposed to concentrations of 0, 3.91, 7.81, 15.6, 31.3, 62.5, 125, and 250 ug/mL for 48 -72 hrs both with and without metabolic activation. The number of revertant colonies was then counted.
No significant increases in the ratio of mutations over controls was seen. The test substance is not mutagenic in either the presence or absence of metabolic activation. - Executive summary:
The purpose of this study was to determine the mutagenicity of the test substance Normal-Heptane. A reverse mutation assay was done using S. typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100, and E. coli strains WP2 and WP2 uvr A. The strains were exposed to concentrations of 0, 3.91, 7.81, 15.6, 31.3, 62.5, 125, and 250 ug/mL for 48 -72 hrs both with and without metabolic activation. The number of revertant colonies was then counted.
No significant increases in the ratio of mutations over controls was seen. The test substance is not mutagenic in either the presence or absence of metabolic activation.
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