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EC number: 297-627-7 | CAS number: 93685-79-1
- 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
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study, the protocol and the results were described with details. Substance analytical certificate not available
- 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
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study, the protocol and the results were described with details. Substance analytical certificate not available
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Additional information on results:
- See tables 7.6.1/3, 7.6.1/4, 7.6.1/5 and 7.6.1/6
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: no data
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES:
A preliminary toxicity assay was conducted with strains TA98 and TA100 at concentrations between 1 and 5000 µg/plate. The plates with the test article showed normal background growth up to 5000.0 µg/plate in strain TA98 and TA100.
COMPARISON WITH HISTORICAL CONTROL DATA: no
ADDITIONAL INFORMATION ON CYTOTOXICITY: no - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results:
negative TA1535; TA1537; TA98 and TA 100
Under the conditions of the assay, Isohexadecan did not demonstrate in vitro mutagenic activity in the Salmonella test system with and without S9 mix activation system. - Executive summary:
This data is being read across from the source study that tested Isohexadecane based on analogue read across.
In a reverse gene mutation assay in bacteria (Poth, 1990) and in compliance with Good Laboratory Practice, strains TA98, TA100, TA1535 and TA1537 of S. typhimurium were exposed to Isohexadecan at concentrations of 10.0, 100.0, 333.3, 1000.0 and 5000.0 µg/plate in the presence and absence of mammalian metabolic activation. No cytotoxicity was observed with all the dose tested. Up to the highest investigated dose, no significant and reproducible dose-dependent increase in revertant colony numbers was obtained in any of the Salmonella typhimurium strains used (+/- S9). The positive controls induced the appropriate responses in the corresponding strains. Under the test conditions, Isohexadecan did not induce in vitro mutagenic activity in the bacterial test system in the presence and the absence of S9 activation system.
Table 7.6.1/3: Number of revertants per plate (mean of triplicates) in the absence of metabolic activation (First test)
Test substance concentration |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
||||||||
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Standard deviation |
Factor + |
||
Negative* control |
12 |
1.2 |
- |
8 |
0.6 |
- |
16 |
1.0 |
- |
77 |
10.0 |
- |
Solvent control** |
10 |
0.6 |
1.0 |
7 |
0.6 |
1.0 |
19 |
5.1 |
1.0 |
83 |
7.4 |
1.0 |
10 |
10 |
2.6 |
1.0 |
8 |
1.7 |
1.0 |
14 |
6.4 |
0.7 |
78 |
8.5 |
0.9 |
100 |
11 |
3.8 |
1.1 |
8 |
1.7 |
1.1 |
16 |
2.1 |
0.8 |
73 |
12.1 |
0.9 |
333.3 |
10 |
4.4 |
1.0 |
7 |
1.5 |
1.0 |
19 |
4.2 |
1.0 |
78 |
12.4 |
0.9 |
1000.0 |
11 |
3.6 |
1.1 |
7 |
1.0 |
17 |
1.2 |
0.9 |
79 |
4.7 |
0.9 |
|
5000.0 |
13 |
4.6 |
1.3 |
5 |
0 |
0.7 |
22 |
2.9 |
1.1 |
73 |
7.4 |
0.9 |
Positive control*** |
839 |
20.2 |
86.8 |
228 |
9.8 |
31.1 |
1694 |
244.4 |
87.6 |
1065 |
48.5 |
12.8 |
Negative control*: concurrent untreated control
Solvent control**: ethanol
Positive control***: see table 7.6.1/2
Table 7.6.1/4: Number of revertants per plate (mean of triplicates) in the presence of metabolic activation (First test)
Test substance concentration |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
||||||||
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
|
Negative control* |
10 |
3.1 |
- |
9 |
1.5 |
- |
32 |
2.0 |
- |
91 |
10.4 |
- |
Solvent control** |
11 |
2.6 |
1.0 |
7 |
3.0 |
1.0 |
38 |
6.1 |
1.0 |
85 |
8.5 |
1.0 |
10 |
12 |
4.7 |
1.1 |
11 |
4.4 |
1.6 |
26 |
5.3 |
0.7 |
77 |
5.5 |
0.9 |
100 |
12 |
2.0 |
1.1 |
8 |
3.5 |
1.2 |
20 |
4.0 |
0.5 |
72 |
5.0 |
0.8 |
333.3 |
12 |
3.8 |
1.1 |
8 |
2.0 |
1.1 |
26 |
0.6 |
0.7 |
73 |
13.6 |
0.9 |
1000.0 |
10 |
3.0 |
0.9 |
12 |
4.0 |
1.7 |
28 |
5.0 |
0.7 |
81 |
7.6 |
1.0 |
5000.0 |
12 |
3.2 |
1.1 |
11 |
1.7 |
1.6 |
36 |
6.7 |
0.9 |
80 |
5.5 |
0.9 |
Positive control*** |
284 |
11.1 |
25.8 |
252 |
28.0 |
36.0 |
1916 |
60.5 |
50.4 |
1681 |
150.2 |
19.7 |
Negative control*:concurrent untreated control
Solvent control** ethanol
Positive control***: see Table 7.6.1/2
Table 7.6.1/5: Number of revertants per plate (mean of triplicates) in the absence of metabolic activation (second test)
Test substance concentration |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
||||||||
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
|
Negative control* |
6 |
1.2 |
- |
5 |
1.0 |
- |
15 |
0.6 |
- |
80 |
11.0 |
- |
Solvent control** |
9 |
2.6 |
1.0 |
5 |
0.6 |
1.0 |
16 |
2.1 |
1.0 |
86 |
9.6 |
1.0 |
10 |
9 |
2.5 |
1.1 |
4 |
1.5 |
0.9 |
11 |
1.2 |
0.7 |
73 |
8.9 |
0.8 |
100 |
7 |
2.9 |
1.1 |
4 |
1.2 |
0.9 |
12 |
4.5 |
0.5 |
74 |
4.0 |
0.9 |
333.3 |
8 |
2.6 |
1.1 |
5 |
2.1 |
1.0 |
14 |
2.6 |
0.7 |
74 |
11.1 |
0.9 |
1000.0 |
7 |
1.0 |
0.9 |
4 |
0.6 |
0.9 |
14 |
2.6 |
0.7 |
82 |
4.7 |
1.0 |
5000.0 |
7 |
1.2 |
1.1 |
4 |
1.5 |
0.8 |
18 |
2.6 |
0.9 |
72 |
6.0 |
0.8 |
Positive control*** |
675 |
33.6 |
75.0 |
162 |
27.2 |
34.6 |
1068 |
370.0 |
65.4 |
967 |
150.2 |
11.2 |
Negative control*: concurrent untreated control
Solvent control**: ethanol
Positive control***: see table 7.6.1/2
Table 7.6.1/6: Number of revertants per plate (mean of triplicates) in the presence of metabolic activation (second test)
Test substance concentration |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
||||||||
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
|
Negative control* |
7 |
3.5 |
- |
5 |
1.0 |
- |
27 |
1.2 |
- |
82 |
9.6 |
- |
Solvent control** |
6 |
1.5 |
1.0 |
10 |
1.2 |
1.0 |
34 |
6.9 |
1.0 |
86 |
4.5 |
1.0 |
10 |
9 |
2.6 |
1.4 |
7 |
1.0 |
0.7 |
29 |
1.7 |
0.9 |
70 |
3.2 |
0.8 |
100 |
6 |
3.1 |
0.9 |
6 |
1.5 |
0.7 |
35 |
3.0 |
1.0 |
79 |
8.5 |
0.9 |
333.3 |
6 |
1.2 |
1.0 |
4 |
1.2 |
0.4 |
32 |
7.2 |
0.9 |
83 |
10.1 |
1.0 |
1000.0 |
7 |
3.5 |
1.2 |
6 |
2.1 |
0.6 |
31 |
6.0 |
0.9 |
81 |
9.2 |
0.9 |
5000.0 |
6 |
1.0 |
0.9 |
6 |
1.5 |
0.7 |
31 |
6.8 |
0.9 |
76 |
6.7 |
0.9 |
Positive control*** |
199 |
9.8 |
31.4 |
211 |
42.7 |
21.8 |
1250 |
102.1 |
36.8 |
1515 |
116.3 |
17.7 |
Negative control*: concurrent untreated control
Solvent control**: ethanol
Positive control***: see table 7.6.1/2
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only 4 bacterial strains were used instead of 5
- Principles of method if other than guideline:
- Guideline study
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2,4,4,6,8,8-heptamethylnonane
- EC Number:
- 224-506-8
- EC Name:
- 2,2,4,4,6,8,8-heptamethylnonane
- Cas Number:
- 4390-04-9
- Molecular formula:
- C16H34
- IUPAC Name:
- 2,2,4,4,6,8,8-heptamethylnonane
- Details on test material:
- - Name of test material (as cited in study report): BP Solvent IH/Isohexadecan
- Substance type: petroleum product, UVCB
- Analytical purity : 100% commercial product
Constituent 1
Method
- Target gene:
- Reversion Histidine auxotrophy
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Remarks:
- The strain cultures were stored as stock cultures in ampoules with nutrient broth + 5% DMSO in liquid nitrogen.
- Metabolic activation:
- with and without
- Metabolic activation system:
- The S9 liver microsomal fraction was obtained from the liver of 8-12 weeks old male wistar rats; strain WU (Savo-Ivanovas, med. Versuchstier Zuchten GmbH) which received a single i.p. injection of 500 mg/kg b.w. Aroclor 1254 in olive oil 5 days previously
- Test concentrations with justification for top dose:
- 10.0; 100.0; 333.3; 1000 and 5000 µg/plate (With and without S9 mix)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: the solvent was chosen to its solubility properties and its relative non-toxicity for the bacteria.
Controls
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: See below Table 7.6.1/2
- Remarks:
- 6 plate for negative control (untreated strains), 6 plate for solvent, 3 plates for positive controls.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
After range-finding test, two independent experiments were conducted in the main test by agar plate incorporation with and without S9 mix. The different controls (negative, solvent and positive controls) were tested in the same conditions.
DURATION
- Preincubation period: the bacterial culture was incubated in a shaking water bath for 6 hours at 37°C.
- Exposure duration: 3 days at 37°C in the dark
SELECTION AGENT (mutation assays):histidine
NUMBER OF REPLICATION: three scoring (3 measurements/plate), the mean number and standard deviation of revertants are calculated for all groups. the means for all treatment groups are compared with those obtained for the solvent control groups.
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; relative total growth
Other: the colonies were counted using the BIOTRAN III counter. If precipitation of the test article precluded automatic counting the revertant colonies were counted by hand. - Evaluation criteria:
- - A positive response was indicated by a reproducible, dose-related increase, whether it be two-fold over background or not.
- Mutation Factors (MF) (induced/spontaneous revertants) were calculated for all strains at the dose level tested. - Statistics:
- A compound is deemed to provide evidence of mutagenic potential if:
- a statistically significant dose-related increase in the number of revertant colonies is obtained in two separate experiments, and
- the increase in the number of revertant colonies is at least twice the concurrent solvent control value.
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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Additional information on results:
- See tables 7.6.1/3, 7.6.1/4, 7.6.1/5 and 7.6.1/6
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: no data
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES:
A preliminary toxicity assay was conducted with strains TA98 and TA100 at concentrations between 1 and 5000 µg/plate. The plates with the test article showed normal background growth up to 5000.0 µg/plate in strain TA98 and TA100.
COMPARISON WITH HISTORICAL CONTROL DATA: no
ADDITIONAL INFORMATION ON CYTOTOXICITY: no - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 7.6.1/3: Number of revertants per plate (mean of triplicates) in the absence of metabolic activation (First test)
Test substance concentration |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
||||||||
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Standard deviation |
Factor + |
||
Negative* control |
12 |
1.2 |
- |
8 |
0.6 |
- |
16 |
1.0 |
- |
77 |
10.0 |
- |
Solvent control** |
10 |
0.6 |
1.0 |
7 |
0.6 |
1.0 |
19 |
5.1 |
1.0 |
83 |
7.4 |
1.0 |
10 |
10 |
2.6 |
1.0 |
8 |
1.7 |
1.0 |
14 |
6.4 |
0.7 |
78 |
8.5 |
0.9 |
100 |
11 |
3.8 |
1.1 |
8 |
1.7 |
1.1 |
16 |
2.1 |
0.8 |
73 |
12.1 |
0.9 |
333.3 |
10 |
4.4 |
1.0 |
7 |
1.5 |
1.0 |
19 |
4.2 |
1.0 |
78 |
12.4 |
0.9 |
1000.0 |
11 |
3.6 |
1.1 |
7 |
1.0 |
17 |
1.2 |
0.9 |
79 |
4.7 |
0.9 |
|
5000.0 |
13 |
4.6 |
1.3 |
5 |
0 |
0.7 |
22 |
2.9 |
1.1 |
73 |
7.4 |
0.9 |
Positive control*** |
839 |
20.2 |
86.8 |
228 |
9.8 |
31.1 |
1694 |
244.4 |
87.6 |
1065 |
48.5 |
12.8 |
Negative control*: concurrent untreated control
Solvent control**: ethanol
Positive control***: see table 7.6.1/2
Table 7.6.1/4: Number of revertants per plate (mean of triplicates) in the presence of metabolic activation (First test)
Test substance concentration |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
||||||||
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
|
Negative control* |
10 |
3.1 |
- |
9 |
1.5 |
- |
32 |
2.0 |
- |
91 |
10.4 |
- |
Solvent control** |
11 |
2.6 |
1.0 |
7 |
3.0 |
1.0 |
38 |
6.1 |
1.0 |
85 |
8.5 |
1.0 |
10 |
12 |
4.7 |
1.1 |
11 |
4.4 |
1.6 |
26 |
5.3 |
0.7 |
77 |
5.5 |
0.9 |
100 |
12 |
2.0 |
1.1 |
8 |
3.5 |
1.2 |
20 |
4.0 |
0.5 |
72 |
5.0 |
0.8 |
333.3 |
12 |
3.8 |
1.1 |
8 |
2.0 |
1.1 |
26 |
0.6 |
0.7 |
73 |
13.6 |
0.9 |
1000.0 |
10 |
3.0 |
0.9 |
12 |
4.0 |
1.7 |
28 |
5.0 |
0.7 |
81 |
7.6 |
1.0 |
5000.0 |
12 |
3.2 |
1.1 |
11 |
1.7 |
1.6 |
36 |
6.7 |
0.9 |
80 |
5.5 |
0.9 |
Positive control*** |
284 |
11.1 |
25.8 |
252 |
28.0 |
36.0 |
1916 |
60.5 |
50.4 |
1681 |
150.2 |
19.7 |
Negative control*:concurrent untreated control
Solvent control** ethanol
Positive control***: see Table 7.6.1/2
Table 7.6.1/5: Number of revertants per plate (mean of triplicates) in the absence of metabolic activation (second test)
Test substance concentration |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
||||||||
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
|
Negative control* |
6 |
1.2 |
- |
5 |
1.0 |
- |
15 |
0.6 |
- |
80 |
11.0 |
- |
Solvent control** |
9 |
2.6 |
1.0 |
5 |
0.6 |
1.0 |
16 |
2.1 |
1.0 |
86 |
9.6 |
1.0 |
10 |
9 |
2.5 |
1.1 |
4 |
1.5 |
0.9 |
11 |
1.2 |
0.7 |
73 |
8.9 |
0.8 |
100 |
7 |
2.9 |
1.1 |
4 |
1.2 |
0.9 |
12 |
4.5 |
0.5 |
74 |
4.0 |
0.9 |
333.3 |
8 |
2.6 |
1.1 |
5 |
2.1 |
1.0 |
14 |
2.6 |
0.7 |
74 |
11.1 |
0.9 |
1000.0 |
7 |
1.0 |
0.9 |
4 |
0.6 |
0.9 |
14 |
2.6 |
0.7 |
82 |
4.7 |
1.0 |
5000.0 |
7 |
1.2 |
1.1 |
4 |
1.5 |
0.8 |
18 |
2.6 |
0.9 |
72 |
6.0 |
0.8 |
Positive control*** |
675 |
33.6 |
75.0 |
162 |
27.2 |
34.6 |
1068 |
370.0 |
65.4 |
967 |
150.2 |
11.2 |
Negative control*: concurrent untreated control
Solvent control**: ethanol
Positive control***: see table 7.6.1/2
Table 7.6.1/6: Number of revertants per plate (mean of triplicates) in the presence of metabolic activation (second test)
Test substance concentration |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
||||||||
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
Mean |
Standard deviation |
Factor + |
|
Negative control* |
7 |
3.5 |
- |
5 |
1.0 |
- |
27 |
1.2 |
- |
82 |
9.6 |
- |
Solvent control** |
6 |
1.5 |
1.0 |
10 |
1.2 |
1.0 |
34 |
6.9 |
1.0 |
86 |
4.5 |
1.0 |
10 |
9 |
2.6 |
1.4 |
7 |
1.0 |
0.7 |
29 |
1.7 |
0.9 |
70 |
3.2 |
0.8 |
100 |
6 |
3.1 |
0.9 |
6 |
1.5 |
0.7 |
35 |
3.0 |
1.0 |
79 |
8.5 |
0.9 |
333.3 |
6 |
1.2 |
1.0 |
4 |
1.2 |
0.4 |
32 |
7.2 |
0.9 |
83 |
10.1 |
1.0 |
1000.0 |
7 |
3.5 |
1.2 |
6 |
2.1 |
0.6 |
31 |
6.0 |
0.9 |
81 |
9.2 |
0.9 |
5000.0 |
6 |
1.0 |
0.9 |
6 |
1.5 |
0.7 |
31 |
6.8 |
0.9 |
76 |
6.7 |
0.9 |
Positive control*** |
199 |
9.8 |
31.4 |
211 |
42.7 |
21.8 |
1250 |
102.1 |
36.8 |
1515 |
116.3 |
17.7 |
Negative control*: concurrent untreated control
Solvent control**: ethanol
Positive control***: see table 7.6.1/2
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative TA1535; TA1537; TA98 and TA 100
Under the conditions of the assay, Isohexadecan did not demonstrate in vitro mutagenic activity in the Salmonella test system with and without S9 mix activation system. - Executive summary:
In a reverse gene mutation assay in bacteria (Poth, 1990) and in compliance with Good Laboratory Practice, strains TA98, TA100, TA1535 and TA1537 of S. typhimurium were exposed to Isohexadecan at concentrations of 10.0, 100.0, 333.3, 1000.0 and 5000.0 µg/plate in the presence and absence of mammalian metabolic activation. No cytotoxicity was observed with all the dose tested. Up to the highest investigated dose, no significant and reproducible dose-dependent increase in revertant colony numbers was obtained in any of the Salmonella typhimurium strains used (+/- S9). The positive controls induced the appropriate responses in the corresponding strains. Under the test conditions, Isohexadecan did not induce in vitro mutagenic activity in the bacterial test system in the presence and the absence of S9 activation system.
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