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EC number: 932-051-8 | CAS number: -
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- May 25, 1995-November 23, 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study done according to OECD guidelines. However, this study does not adequately address the results obtained at mildly cytotoxic concentrations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Benzenesulfonic acid, C10-13 alkyl derivatives, sodium salt
- IUPAC Name:
- Benzenesulfonic acid, C10-13 alkyl derivatives, sodium salt
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from Aroclor 1254 induced rat liver
- Test concentrations with justification for top dose:
- All concentrations in micrograms/ml
Test 1 with S9: 0.32, 0.63, 1.25, 2.5, 5, 10, 20, 39, 78
Test 1 without S9: 1.25, 2.5, 5, 10, 20, 39, 58,78, 156
Test 2 with S9: 2.5, 5, 10, 20, 26, 33, 39
Test 2 without S9: 20, 39, 58, 78, 130, 156
An additional test was done with S9 at the following dose levels:
2.5, 5, 7.5, 10, 15, 20, 25, and 30 ug/ml - Vehicle / solvent:
- None
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: methyl methanesulphonate, cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 6 hrs with S9, 22 hrs without S9
- Expression time (cells in growth medium): 16-40 hrs with S9, 40 hrs without S9
- Selection time (if incubation with a selection agent): 2 hrs
- Fixation time (start of exposure up to fixation or harvest of cells): 24-48 hrs
SELECTION AGENT (mutation assays): Colcemid
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: 100 metaphases
DETERMINATION OF CYTOTOXICITY
- Method: number of cells per culture
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes - Evaluation criteria:
- A dosage was considered toxic if cell count was less then 60% of cell cultures. A test substance was considered clastogenic if a single dose caused the percentage of aberrant cells to be consistently greater than the 99% confidence limits of negative controls and there was also an increase at another dose level.
- Statistics:
- 95% and 99% confidence limits
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >= 15 microgram/ml with S9, >=58 microgram/ml without S9
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the absence of S9, only one culture (Test 2, 24 hr harvest, 20 ug/ml) showed a suspicious result. This single result was considered sporadic, as other cultures at this concentration, or at higher concentrations did not show a positive response. In Test 1, in the absence of S9, cytoxicity was seen at 78 micrograms/ml and above. In Test 2, in the absence of S9, cytoxicity was seen at concentrations of 58 micrograms/ml and above.
In Test 1, in the presence of S9, no positive results were seen at concentrations of up to 20 micrograms/ml. Metaphases could not be analyzed due to severe cytotoxicity at the 39 and 78 microgram/ml concentrations. In Test 2, in the presence of S9, one of the cultures at the 5 microgram/ml concentration gave a suspicious result, and both cultures at the 10 microgram/ml concentrations gave positive responses. Mild cytotoxity was also seen at the 10 microgram/ml concentration. At concentrations at and above 20 micrograms/ml, metaphases could not be analyzed due to severe cytotoxicity. No positive results were seen in the Test 2, 48 hr harvest cultures grown in the presence of S9, though moderate cytotoxicity was seen in one of the 20 microgram/ml cultures, and severe cytotoxicity was seen in all cultures above this concentration.
A third test was done in the presence of S9, which showed positive results at the 15 micrograms/ml concentration. However, this concentration was also moderately cytotoxic with only 26% of cells survival. However, due to the low survival of cells, these results are not definitive for determining clastogenicity. Higher concentrations were completely cytotoxic. An additional assessment was then performed at 10 micrograms/ml in the presence of S9, with negative results. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Abbreviations used in tables:
T ¿ Toxicity evident from morphological changes
TT- Toxicity evident from reduced cell count (<60% of vehicle)
TTT- Too toxic for metaphase assessment
Concentration (micrograms/ml) |
Aberration Frequency (lesions/cell) |
Aberrant Cell Frequency (% Including Gaps) |
Aberrant Cell Frequency (% Excluding Gaps) |
Cytotoxicity |
Ham¿s F10 medium |
0.01 |
1 |
0 |
Nil |
Ham¿s F10 medium |
0.02 |
1 |
1 |
Nil |
0.32 |
- |
- |
- |
Nil |
0.32 |
- |
- |
- |
Nil |
0.63 |
- |
- |
- |
Nil |
0.63 |
- |
- |
- |
Nil |
1.25 |
- |
- |
- |
Nil |
1.25 |
- |
- |
- |
Nil |
2.5 |
0.01 |
1 |
0 |
Nil |
2.5 |
0.00 |
0 |
0 |
Nil |
5 |
0.00 |
0 |
0 |
Nil |
5 |
0.05 |
5 |
0 |
Nil |
10 |
0.01 |
1 |
0 |
Nil |
10 |
0.01 |
1 |
0 |
Nil |
20 |
0.00 |
0 |
0 |
Nil |
20 |
0.00 |
0 |
0 |
Nil |
39 |
- |
- |
- |
TTT |
39 |
- |
- |
- |
TTT |
78 |
- |
- |
- |
TTT |
78 |
- |
- |
- |
TTT |
Cyclophosphamide (20 micrograms/ml) |
0.14 |
8 |
4 |
- |
Cyclophosphamide (30 micrograms/ml) |
0.06 |
4 |
4 |
- |
Cyclophosphamide (40 micrograms/ml) |
0.33 |
20 |
19 |
- |
Test 1 ¿ Without S9 Mix, 24 hr Harvest
Concentration (micrograms/ml) |
Aberration Frequency (lesions/cell) |
Aberrant Cell Frequency (% Including Gaps) |
Aberrant Cell Frequency (% Excluding Gaps) |
Cytotoxicity |
Ham¿s F10 medium |
0.00 |
0 |
0 |
Nil |
Ham¿s F10 medium |
0.00 |
0 |
0 |
Nil |
1.25 |
- |
- |
- |
Nil |
1.25 |
- |
- |
- |
Nil |
2.5 |
- |
- |
- |
Nil |
2.5 |
- |
- |
- |
Nil |
5 |
- |
- |
- |
Nil |
5 |
- |
- |
- |
Nil |
10 |
- |
- |
- |
Nil |
10 |
- |
- |
- |
Nil |
20 |
- |
- |
- |
Nil |
20 |
- |
- |
- |
Nil |
39 |
0.01 |
1 |
0 |
Nil |
39 |
0.00 |
0 |
0 |
Nil |
58 |
0.01 |
1 |
0 |
Nil |
58 |
0.00 |
0 |
0 |
Nil |
78 |
0.00 |
0 |
0 |
T |
78 |
0.00 |
0 |
0 |
T |
156 |
- |
- |
- |
TTT |
156 |
- |
- |
- |
TTT |
Methyl methane-sulphonate (10 micrograms/ml) |
0.03 |
3 |
1 |
- |
Cyclophosphamide (20 micrograms/ml) |
0.16 |
14 |
10 |
- |
Test 2 ¿ With S9 Mix, 24 hr Harvest
Concentration (micrograms/ml) |
Aberration Frequency (lesions/cell) |
Aberrant Cell Frequency (% Including Gaps) |
Aberrant Cell Frequency (% Excluding Gaps) |
Cytotoxicity |
Ham¿s F-10 medium |
0.01 |
1 |
0 |
Nil |
Ham¿s F-10 medium |
0.02 |
2 |
1 |
Nil |
2.5 |
0.07 |
2 |
1 |
Nil |
2.5 |
0.04 |
3 |
1 |
Nil |
5 |
0.04 |
3 |
2 |
Nil |
5 |
0.06 |
6 |
4 |
Nil |
10 |
0.12 |
8 |
6 |
T |
10 |
0.19 |
13 |
5 |
T |
20 |
- |
- |
- |
TTT |
20 |
- |
- |
- |
TTT |
26 |
- |
- |
- |
TTT |
26 |
- |
- |
- |
TTT |
33 |
- |
- |
- |
TTT |
33 |
- |
- |
- |
TTT |
39 |
- |
- |
- |
TTT |
39 |
- |
- |
- |
TTT |
Cyclophosphamide (40 micrograms/ml) |
0.38 |
20 |
17 |
- |
Cyclophosphamide (50 micrograms/ml) |
0.31 |
18 |
11 |
- |
Test 2 ¿ With S9 Mix, 48 hr Harvest
Concentration (micrograms/ml) |
Aberration Frequency (lesions/cell) |
Aberrant Cell Frequency (% Including Gaps) |
Aberrant Cell Frequency (% Excluding Gaps) |
Cytotoxicity |
Ham¿s F-10 medium |
0.00 |
0 |
0 |
Nil |
Ham¿s F-10 medium |
0.00 |
0 |
0 |
Nil |
2.5 |
0.01 |
1 |
0 |
Nil |
2.5 |
0.01 |
1 |
1 |
Nil |
5 |
0.00 |
0 |
0 |
Nil |
5 |
0.02 |
2 |
2 |
Nil |
10 |
0.03 |
2 |
1 |
Nil |
10 |
0.02 |
2 |
1 |
TT |
20 |
- |
- |
- |
TTT |
20 |
- |
- |
- |
TTT |
26 |
- |
- |
- |
TTT |
26 |
- |
- |
- |
TTT |
33 |
- |
- |
- |
TTT |
33 |
- |
- |
- |
TTT |
39 |
- |
- |
- |
TTT |
39 |
- |
- |
- |
TTT |
Cyclophosphamide (40 micrograms/ml) |
0.03 |
3 |
2 |
- |
Cyclophosphamide (50 micrograms/ml) |
0.10 |
8 |
7 |
- |
Test 2 ¿ Without S9 Mix, 24 hr Harvest
Concentration (micrograms/ml) |
Aberration Frequency (lesions/cell) |
Aberrant Cell Frequency (% Including Gaps) |
Aberrant Cell Frequency (% Excluding Gaps) |
Cytotoxicity |
Ham¿s F-10 medium |
0.02 |
2 |
2 |
Nil |
Ham¿s F-10 medium |
0.03 |
3 |
0 |
Nil |
20 |
0.02 |
2 |
0 |
Nil |
20 |
0.05 |
5 |
3 |
Nil |
39 |
0.02 |
2 |
1 |
Nil |
39 |
0.04 |
4 |
0 |
Nil |
58 |
0.01 |
1 |
1 |
Nil |
58 |
0.06 |
6 |
1 |
Nil |
78 |
- |
- |
- |
TTT |
78 |
- |
- |
- |
TTT |
104 |
- |
- |
- |
TTT |
104 |
- |
- |
- |
TTT |
130 |
- |
- |
- |
TTT |
130 |
- |
- |
- |
TTT |
156 |
- |
- |
- |
TTT |
156 |
- |
- |
- |
TTT |
Methyl methane-sulphonate (10 micrograms/ml) |
0.30 |
21 |
14 |
- |
Methyl methane-sulphonate (20 micrograms/ml) |
0.71 |
33 |
28 |
- |
Test 2 ¿ Without S9 Mix, 48 hr Harvest
Concentration (micrograms/ml) |
Aberration Frequency (lesions/cell) |
Aberrant Cell Frequency (% Including Gaps) |
Aberrant Cell Frequency (% Excluding Gaps) |
Cytotoxicity |
Ham¿s F-10 medium |
0.01 |
1 |
1 |
Nil |
Ham¿s F-10 medium |
0.00 |
0 |
0 |
Nil |
20 |
0.00 |
0 |
0 |
Nil |
20 |
0.00 |
0 |
0 |
Nil |
39 |
0.01 |
1 |
1 |
Nil |
39 |
0.00 |
0 |
0 |
Nil |
58 |
0.00 |
0 |
0 |
T |
58 |
0.01 |
1 |
0 |
T |
78 |
- |
- |
- |
TTT |
78 |
- |
- |
- |
TTT |
104 |
- |
- |
- |
TTT |
104 |
- |
- |
- |
TTT |
130 |
- |
- |
- |
TTT |
130 |
- |
- |
- |
TTT |
156 |
- |
- |
- |
TTT |
156 |
- |
- |
- |
TTT |
Methyl methane-sulphonate (20 micrograms/ml) |
0.21 |
11 |
8 |
- |
Methyl methane- sulphonate (40 micrograms/ml) |
3.20 |
60 |
60 |
- |
Test 3 ¿ With S9 Mix, 24 hr Harvest
Concentration (micrograms/ml) |
Aberration Frequency (lesions/cell) |
Aberrant Cell Frequency (% Including Gaps) |
Aberrant Cell Frequency (% Excluding Gaps) |
Cytoxicity |
Ham¿s F-10 medium |
0.04 |
4 |
0 |
Nil |
Ham¿s F-10 medium |
0.04 |
4 |
0 |
Nil |
2.5 |
- |
- |
- |
Nil |
2.5 |
- |
- |
- |
Nil |
5 |
- |
- |
- |
Nil |
5 |
- |
- |
- |
Nil |
7.5 |
- |
- |
- |
Nil |
7.5 |
- |
- |
- |
Nil |
10 |
- |
- |
- |
Nil |
10 |
- |
- |
- |
Nil |
15 |
0.20 |
12 |
8 |
TT |
15 |
0.18 |
12 |
6 |
TT |
20 |
- |
- |
- |
TTT |
20 |
- |
- |
- |
TTT |
25 |
- |
- |
- |
TTT |
25 |
- |
- |
- |
TTT |
30 |
- |
- |
- |
TTT |
30 |
- |
- |
- |
TTT |
Cyclophosphamide (30 micrograms/ml) |
0.24 |
14 |
12 |
- |
Cyclophosphamide (40 micrograms/ml) |
0.32 |
17 |
11 |
- |
Test 3 - see tables below
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
positive with metabolic activation at cytotoxic concentrations or above
The test substance is not clastogenic in the absence of metabolic activation. The test substance is also not clastogenic in the presence of metabolic activation at non-cytotoxic concentrations. At cytotoxic concentrations, the test substance is weakly clastogenic. - Executive summary:
This study examined the potential of the test substance Marlon A 350 to cause chromosomal aberrations in mammalian cells. Chinese hamster ovary cells were exposed to concentrations of 0.32 to 78 ug/ml with S9, and 1.25 to 156 ug/ml without S9. Methyl methanesuflphonate and cyclophosphamide were used as positive controls. No biologically significant results were seen in treated cultures in the absence of metabolic activation. Positive responses were seen at cytotoxic concentrations in the presence of S9. Concentrations below the level of cytotoxicty with S9 did not show positive results. The test substance is not clastogenic in the absence of metabolic activation, or with metabolic activation below cytotoxic concentrations. These results indicate that LAS is weakly clastogenic at cytotoxic concentrations but negative at concentrations below cytotoxic concentrations
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