Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-999-8 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No key genetic toxicity data with the target substance is available. A read across evaluation was developed with LABS Na as supporting substance. LABS Na was demonstrated to be negative in 3 in vitro mutagenicity and clastogenicity tests: a bacterial mutagenicity study (Ames test), a chromosome aberration test, and mammalian cell gene mutation test.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 16, 1995-June 30, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): MARLON A 350
- Physical state: viscous, yellowish liquid
- Analytical purity: 49.7-49.9 % MARLON A
- Lot/batch No.: 95/14
- Stability under test conditions: < 1 yr
- Storage condition of test material: dry and cool in closed container - 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:
- 0, 0.6, 1, 1.8, 3, 6 ug/ml without S9
0, 6, 10, 18, 30, 60 ug/ml with S9 - Vehicle / solvent:
- None
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- yes
- Remarks:
- H0 medium
- Positive controls:
- yes
- Positive control substance:
- other: ethyl methane sulfonate; 3-(20-)methylcholanthrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 1 week
- Exposure duration: 4 hrs
- Expression time (cells in growth medium): 6 days at 37 degree C for cloning efficiency study, 9 days for mutation assay
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2
- Evaluation criteria:
- A test substance was considered mutagenic if a statistically significant dose-related increase in mutant frequency was found in concentrations with greater than 20% survival rate. The mean mutant frequency must also be significantly above the maximum spontaneous mutant frequency.
- Statistics:
- Statistical significance was determined by the t-test.
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- preliminary test showed cytotoxicity at >= 50 ug/ml without S9, and >= 100 ug/ml with S9.
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: In both the studies with and without S9, the mutant frequencies in the treated groups were statistically significantly higher than in the concurrent negative controls. However, the mutant frequencies in the treated groups were not significantly increased when compared to historical negative controls. There was also no dose-response relationship. The increased mutant frequency in treated groups was therefore not considered to be biologically significant.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- The test substance is not mutagenic in either the presence or absence of metabolic activation.
- Executive summary:
This study examined the potential of the test substance to cause mutations in mammalian cells. Chinese Hamster Ovary (CHO) cells were exposed to concentrations of 0, 0.6, 1, 1.8, 3, and 6 ug/ml without S9, and 0, 6, 10, 18, 30, and 60 ug/ml with S9. The cells were then examined for cytogenicity and mutation frequency. Ethyl methane sulfonate and 3-(20-)methylcholanthrene were used as positive control substances. Preliminary tests show the test substance was cytogenic at concentrations of 50 ug/ml or greater with metabolic activation, and 100 ug/ml or above without metabolic activation. There was no biologically significant increase in mutation frequency in the treated groups. The test substance is considered not mutagenic to CHO cells both in the presence and absence of S9.
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Principles of method if other than guideline:
- Directive 84/449/EEC, B.14 Mutagenicity (Salmonella typhimurium - reverse mutation assay)" 1984; equivalent to OECD 471
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Marlon A 390 (CAS #68411-30-3) Sodium salts of C10-13 alkyl benzenesulphonic acid, average alkyl chain length = C11.6; activity 91.3%
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- also TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor-induced S9 fraction
- Test concentrations with justification for top dose:
- 8, 40, 200, 1000 and 5000 ug/plate
- Vehicle / solvent:
- Water solution at 50 g/L
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- yes
- Positive controls:
- yes
- Remarks:
- aminoanthracene
- Positive control substance:
- other: nitrofluorene, sodium azide and aminoacridine
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- with and without activation
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TA 1538 also tested negative. During the pre-incubation test, signs of toxicity were noted at concentrations as low as 125 ug/plate. No precipitation of the product was observed at any concentration tested.
- Conclusions:
- LAS is not mutagenic in the Ames test.
- Executive summary:
A bacterial mutagenicity study (Ames test) was conducted on LAS and was found to be negative for mutagenicity.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- 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.
- 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
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): MARLON A 350
- Physical state: yellow liquid
- Analytical purity: 50% MARLON A 350, 50% water
- Lot/batch No.: 95/14
- Storage condition of test material: dark at ambient temperature - 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
- 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
- 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'.
- Conclusions:
- 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
Referenceopen allclose all
Results of Test 1 ¿ Without S9 Mix
Concentration (ug/ml) |
Absolute cloning efficiency (%) |
Mutant frequency ( x 106) |
0 |
82 |
3 ± 2 |
0.6 |
86 |
7 ± 1 |
1 |
85 |
3 ± 2 |
1.8 |
78 |
5 ± 2 |
3 |
86 |
1 ± 1 |
6 |
83 |
0 ± 1 |
EMS |
83 |
277 ± 17 |
Results of Test 1 ¿ With S9 Mix
Concentration (ug/ml) |
Absolute cloning efficiency (%) |
Mutant frequency ( x 106) |
0 |
90 |
2 ± 1 |
6 |
88 |
1 ± 1 |
10 |
84 |
9 ± 4 |
18 |
78 |
5 ± 3 |
30 |
89 |
3 ± 2 |
60 |
89 |
7 ± 2 |
MCA |
81 |
91 ± 9 |
Results of Test 2 ¿ Without S9 Mix
Concentration (ug/ml) |
Absolute cloning efficiency (%) |
Mutant frequency ( x 106) |
0 |
96 |
1 ± 1 |
0.6 |
92 |
2 ± 3 |
1 |
95 |
1 ± 1 |
1.8 |
93 |
5 ± 2 |
3 |
90 |
2 ± 1 |
6 |
91 |
6 ± 6 |
EMS |
90 |
309 ± 20 |
Results of Test 2 ¿ With S9 Mix
Concentration (ug/ml) |
Absolute cloning efficiency (%) |
Mutant frequency ( x 106) |
0 |
90 |
2 ± 1 |
6 |
92 |
7 ± 3 |
10 |
88 |
9 ± 2 |
18 |
94 |
2 ± 1 |
30 |
93 |
2 ± 2 |
60 |
90 |
5 ± 1 |
MCA |
95 |
89 ± 6 |
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
No key genetic toxicity data with the target substance is available. A read across evaluation was developed with LABS Na as supporting substance. LABS Na was demonstrated to be negative in 4 in vivo cytogenicity/chromosome aberration tests.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
No key genetic toxicity data with the target substance is available. A read across evaluation was developed with LABS Na as supporting substance.
genetic toxicity - in vitro
- Ames: A bacterial mutagenicity study (Ames test) was conducted on LABS Na and was found to be negative for mutagenicity.
- Chromosome aberration: 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 methanesulphonate and cyclophosphamide were used as positive controls. No biologically relevant changes 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 cytotoxicity 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 LABS Na is weakly clastogenic at cytotoxic concentrations but negative at concentrations below cytotoxic concentrations.
- Mammalian cell gene mutation test: This study examined the potential of the test substance to cause mutations in mammalian cells. Chinese Hamster Ovary (CHO) cells were exposed to concentrations of 0, 0.6, 1, 1.8, 3, and 6 ug/ml without S9, and 0, 6, 10, 18, 30, and 60 ug/ml with S9. The cells were then examined for cytogenicity and mutation frequency. Ethyl methane sulfonate and 3-(20-)methylcholanthrene were used as positive control substances. Preliminary tests show the test substance was cytogenic at concentrations of 50 ug/ml or greater with metabolic activation, and 100 ug/ml or above without metabolic activation. There was no biologically significant increase in mutation frequency in the treated groups. The test substance is considered not mutagenic to CHO cells both in the presence and absence of S9.
genetic toxicity - in vivo
1/ A group of 7 male mice was fed a diet containing 0.6% test substance for 9 months. At the end of this period, the animals were each mated with two untreated females. On day 13 of pregnancy, the females were sacrificed, and the ovaries and uteri were examined. No increase in dominant lethal induction was seen as compared to controls. The test substance does not cause genetic disorders.
2/ Groups of male mice were given doses of 200, 400, or 800 mg/kg of Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts. At 6, 24, and 48 hrs, 3 of the mice from each dosage group were sacrificed. The bone marrow cells from the femurs were collected and examined for chromosome aberrations. In addition, one group of mice was exposed daily for 5 consecutive days. Additional groups of mice were exposed to commercial detergents containing 19% or 17.1% of the test substance. Mitomycin C was used as a positive control. None of the treatment groups showed any significant increase in chromosome aberrations as compared to negative controls. The test substance in not clastogenic.
3/ Groups of 5 male rats were fed a diet containing 0.9% test substance for 9 months. At the end of this period, the animals were sacrificed, and the bone marrow cells examined for chromosome aberrations. No increase in chromosome aberrations was seen as compared to controls. The test substance is not clastogenic.
4/ A group of 5 male mice was fed a diet containing 0.9% test substance for 9 months. At the end of this period, the animals were sacrificed, and the bone marrow cells examined for chromosome aberrations. No increase in chromosome aberrations was seen as compared to controls. The test substance is not clastogenic.
Justification for classification or non-classification
Based on the results described, the substance is not to be classified as mutagenic according to CLP Regulation.
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.