Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 270-115-0 | CAS number: 68411-30-3
- 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
In vitro and in vivo genotoxicity studies were conducted with the test substance C10-13 LAS. Overall, results from these studies indicate no evidence of genotoxic potential of the tested substance.
Three in vitro genotoxicity studies are available, all providing evidence that LAS Na is negative for in vitro genotoxicity.
The Ames test gave a negative result (Schoeberl, 1993, K1 CSR). This key study was conducted in 1993 and met all test guideline requirements at the time, including use of the five standard test strains,S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538. Williams et al., 2019 reviewed the sensitivity and selectivity of the bacterial strains specified in OECD TG 471, including S. typhimurium TA102,E. coliWP2 uvrA and E. coli WP2 uvrA (pKM101). The authors conclude that “Of the mutagens detected by the full TG471 strain battery, 93% were detected using only strains TA98 and TA100; consideration of results from in vitro genotoxicity assays that detect clastogenicity increased the mutagens detected to 99%.” In this case, possible clastogenicity is examined in an in vitro and in vivo chromosome aberration study and therefore not considered necessary in the Ames test.
Moreover, a reliable in vitro study (Murie and Innes, 1997 K3 CSR) is available in which the potential of LAS Na to cause chromosomal aberrations in mammalian cells was examined. These results indicate that LAS Na is weakly clastogenic in vitro at cytotoxic concentrations but negative at concentrations below cytotoxic concentrations.
Furthermore, the additional in vitro test (Anon., 1995 K2 CSR) that measures the potentialin vitrogenotoxicity of LAS Na to cause mutations in mammalian cells shows that LAS Na was not mutagenic to Chinese Hamster Ovary (CHO) cells both in the presence and absence of S9.
Williams, R.V., DeMarini, D.M., Stankowski Jr., L.F., Escobar, P.A., Zeigler, E., Howe, J., Elespuru, R. and Cross, K.P. 2019. Are all bacterial strains required by OECD mutagenicity test guideline TG471 needed? Mutat. Res. Gen. Tox. En. 848 (2019) 503081, available at: https://doi.org/10.1016/j.mrgentox.2019.503081
Link to relevant study records
- 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)
- Version / remarks:
- 198
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- 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
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- 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 µg/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
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- with and without activation
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- During the pre-incubation test, signs of toxicity were noted at concentrations as low as 125 µg/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- 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 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:
- 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:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
- 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 µg/mL without S9
0, 6, 10, 18, 30, 60 µg/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.
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity preliminary test showed cytotoxicity at >= 50 µg/mL without S9, and >= 100 µg/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.
- 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 µg/mL without S9, and 0, 6, 10, 18, 30, and 60 µg/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 µg/mL or greater with metabolic activation, and 100 µg/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 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:
- guideline study with acceptable restrictions
- Remarks:
- 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
- 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:
Test 1 with S9: 0.32, 0.63, 1.25, 2.5, 5, 10, 20, 39, 78 µg/mL
Test 1 without S9: 1.25, 2.5, 5, 10, 20, 39, 58,78, 156 µg/mL
Test 2 with S9: 2.5, 5, 10, 20, 26, 33, 39 µg/mL
Test 2 without S9: 20, 39, 58, 78, 130, 156 µg/mL
An additional test was done with S9 at the following dose levels:
2.5, 5, 7.5, 10, 15, 20, 25, and 30 µg/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
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- Only at cytotoxic concentrations
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >= 15 µg/mL
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >=58 µg/mL
- 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 µg/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 µg/mL and above. In Test 2, in the absence of S9, cytoxicity was seen at concentrations of 58 µg/mL and above.
In Test 1, in the presence of S9, no positive results were seen at concentrations of up to 20 µg/mL. Metaphases could not be analyzed due to severe cytotoxicity at 39 and 78 µg/mL. In Test 2, in the presence of S9, one of the cultures at 5 µg/mL gave a suspicious result, and both cultures at 10µg/mL gave positive responses. Mild cytotoxity was also seen at 10 µg/mL. At concentrations at and above 20 µg/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 µg/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 µg/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 µg/mL in the presence of S9, with negative results. - 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 to cause chromosomal aberrations in mammalian cells. Chinese hamster ovary cells were exposed to concentrations of 0.32 to 78 µg/mL with S9, and 1.25 to 156 µg/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 the test substance is weakly clastogenic at cytotoxic concentrations but negative at concentrations below cytotoxic concentrations
Referenceopen allclose all
Results of Test 1 - Without S9 Mix
Concentration (µg/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 (µg/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 (µg/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 (µg/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 |
Concentration (µg/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 µg/mL) |
0.14 |
8 |
4 |
- |
Cyclophosphamide (30 µg/mL) |
0.06 |
4 |
4 |
- |
Cyclophosphamide (40 µg/mL) |
0.33 |
20 |
19 |
- |
Test 1 - Without S9 Mix, 24 hr Harvest
Concentration (µg/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 µg/mL) |
0.03 |
3 |
1 |
- |
Cyclophosphamide (20 µg/mL) |
0.16 |
14 |
10 |
- |
T- Toxicity evident from morphological changes
TT- Toxicity evident from reduced cell count (<60% of vehicle)
TTT- Too toxic for metaphase assessment
Test 2 - With S9 Mix, 24 hr Harvest
Concentration (µg/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 µg/mL) |
0.38 |
20 |
17 |
- |
Cyclophosphamide (50 µg/mL) |
0.31 |
18 |
11 |
- |
Test 2 - With S9 Mix, 48 hr Harvest
Concentration (µg/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 µg/mL) |
0.03 |
3 |
2 |
- |
Cyclophosphamide (50 µg/mL) |
0.10 |
8 |
7 |
- |
Test 2 - Without S9 Mix, 24 hr Harvest
Concentration (µg/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 µg/mL) |
0.30 |
21 |
14 |
- |
Methyl methane-sulphonate (20 µg/mL) |
0.71 |
33 |
28 |
- |
Test 2 - Without S9 Mix, 48 hr Harvest
Concentration (µg/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 µg/mL) |
0.21 |
11 |
8 |
- |
Methyl methane- sulphonate (40 µg/mL) |
3.20 |
60 |
60 |
- |
Test 3 - With S9 Mix, 24 hr Harvest
Concentration (µg/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 µg/mL) |
0.24 |
14 |
12 |
- |
Cyclophosphamide (40 µg/mL) |
0.32 |
17 |
11 |
- |
Test 3: With S9 Mix, 24 Hr Harvest
Concentration (µg/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 |
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 µg/mL) |
0.24 |
14 |
12 |
- |
Cyclophosphamide (40 µg/mL) |
0.32 |
17 |
11 |
- |
Test 3: With S9 Mix, 24 Hr Harvest: Additional assessment
Concentration (µg/mL) |
Aberration Frequency (lesions/cell) |
Aberrant Cell Frequency (% Including Gaps) |
Aberrant Cell Frequency (% Excluding Gaps) |
Cytoxicity |
Ham's F-10 medium |
0.02 |
2 |
0 |
Nil |
10 |
0.01 |
1 |
0 |
Nil |
10 |
0.02 |
2 |
0 |
Nil |
Cyclophosphamide (30 µg/mL) |
0.22 |
14 |
10 |
- |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Three key studies to fulfill the information requirement of in vivo genotoxicity are available: a chromosomal aberration assay, in vivo cytogenicity study and dominant lethal test (Masabuchi, 1976 a, b, c; K1, 2, 3) were conducted according to generally accepted procedures at the time the studies were conducted. All studies provide evidence that LAS Na is negative forin vivogenetic toxicity, including chromosomal aberrations.
Furthermore, two supporting studies performed with substances analogous to the test substance are included in the dossier: 1) LAS Acid, the source substance for study (i), in vivo micronucleus assay (Fedtke, 1991; S2 CSR), is identical to the sponsored substance LAS Na as both disassociate in vivo to form the identical substance, the LAS anion, and 2) C10-14 LAS Na, the source substance in study (ii),in vivochromosomal aberration assay (Inoue et al., 1976; S1 CSR) which has very similar composition (slight differences in C10 and C14 content) to the sponsored substance LAS Na. Both of these tests gave negative results, confirming the absence of genotoxic properties in vivo.
Link to relevant study records
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 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.
- GLP compliance:
- no
- Type of assay:
- rodent dominant lethal assay
- Species:
- mouse
- Strain:
- other: JCL-ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CLEA Japan, Inc.
- Age at study initiation: 4 weeks
- Housing: individually, except during breeding
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: feed
- Details on exposure:
- DIET PREPARATION
- Mixing appropriate amounts with: feed powder CE-2 - Duration of treatment / exposure:
- 9 months
- Frequency of treatment:
- daily
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Remarks:
- 0.6% in diet
- No. of animals per sex per dose:
- 7
- Control animals:
- yes
- Statistics:
- Rohrborn's method.
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Negative controls validity:
- valid
- Additional information on results:
- There were no significant differences in fertility, the mortality of ova and embryos, the number of surviving fetuses, or the index of dominant lethal induction between the experimental groups and the control group.
- Conclusions:
- The test substance did not cause genetic disorders in mice.
- Executive summary:
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.
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 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.
- GLP compliance:
- no
- Type of assay:
- mammalian bone marrow chromosome aberration test
- Species:
- rat
- Strain:
- other: Wistar and SD
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CLEA Japan, Inc.
- Age at study initiation: 4 weeks
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: feed
- Details on exposure:
- DIET PREPARATION
- Mixing appropriate amounts with: feed powder CE-2 - Duration of treatment / exposure:
- 9 months
- Frequency of treatment:
- Daily
- Dose / conc.:
- 450 mg/kg bw/day (nominal)
- Remarks:
- 0.9% in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Tissues and cell types examined:
- femur bone marrow cells
- Details of tissue and slide preparation:
- Animals were sacrificed by administration of 1 ml/kg of 1% colchine solution. Femurs were then removed, and bone marrow cells washed into centrifuge tubes. The cells were then treated with 0.075 M KCl solution at 37 °C for 15 min, and then fixed with an acetic acid 1: ethanol 3 solution. Samples were then flame dried and treated with Giemsa.
- Evaluation criteria:
- Presence and absence of chromosomal aberrations. 50 metaphases per individual.
- Statistics:
- Rohrborn's method.
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Negative controls validity:
- valid
- Additional information on results:
- No increase in chromosome aberrations was noted.
- Conclusions:
- The test substance is not clastogenic.
- Executive summary:
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.
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 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.
- GLP compliance:
- no
- Type of assay:
- mammalian bone marrow chromosome aberration test
- Species:
- mouse
- Strain:
- other: JCL-ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CLEA Japan, Inc.
- Age at study initiation: 4 weeks
- Housing: individually, except during breeding
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: feed
- Details on exposure:
- DIET PREPARATION
- Mixing appropriate amounts with: feed powder CE-2 - Duration of treatment / exposure:
- 9 months
- Frequency of treatment:
- Daily
- Dose / conc.:
- 1 170 mg/kg bw/day (nominal)
- Remarks:
- 0.9% in diet
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Tissues and cell types examined:
- femur bone marrow cells
- Details of tissue and slide preparation:
- Animals were sacrificed by administration of 1 ml/kg of 1% colchine solution. Femurs were then removed, and bone marrow cells washed into centrifuge tubes. The cells were then treated with 0.075 M KCl solution at 37 °C for 15 min, and then fixed with an acetic acid 1: ethanol 3 solution. Samples were then flame dried and treated with Giemsa.
- Evaluation criteria:
- Presence and absence of chromosomal aberrations. 50 metaphases per individual.
- Statistics:
- Rohrborn's method.
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Negative controls validity:
- valid
- Additional information on results:
- No increase in chromosome aberrations was noted.
- Conclusions:
- The test substance is not clastogenic.
- Executive summary:
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.
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 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 commericial detergents containing 19% or 17.1% of the test substance. Mitomycin C was used as a positive control.
- GLP compliance:
- no
- Type of assay:
- mammalian bone marrow chromosome aberration test
- Species:
- mouse
- Strain:
- other: ICR/JCL
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CLEA Japan Inc.
- Age at study initiation: 9-11 weeks
- Housing: individually in plastic cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12/12 hrs - Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: distilled water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Samples were diluted to make a 5 mL/kg dose volume
- Duration of treatment / exposure:
- Single treatment, except for one group which was given 5 consecutive daily exposures to the test substance
- Frequency of treatment:
- Once daily
- Dose / conc.:
- 200 mg/kg bw (total dose)
- Remarks:
- Nominal concentration
- Dose / conc.:
- 400 mg/kg bw (total dose)
- Remarks:
- Nominal concentration
- Dose / conc.:
- 800 mg/kg bw (total dose)
- Remarks:
- Nominal concentration
- Dose / conc.:
- 800 mg/kg bw (total dose)
- Remarks:
- Nominal concentration. Commercial detergent containing 19% test substance
- Dose / conc.:
- 1 600 mg/kg bw (total dose)
- Remarks:
- Nominal concentration. Commercial detergent containing 19% test substance
- Dose / conc.:
- 3 200 mg/kg bw (total dose)
- Remarks:
- Nominal concentration. Commercial detergent containing 19% test substance
- Dose / conc.:
- 1 000 mg/kg bw (total dose)
- Remarks:
- Nominal concentration. Commercial detergent containing 17.1% test substance
- Dose / conc.:
- 2 000 mg/kg bw (total dose)
- Remarks:
- Nominal concentration. Commercial detergent containing 17.1% test substance
- Dose / conc.:
- 4 000 mg/kg bw (total dose)
- Remarks:
- Nominal concentration. Commercial detergent containing 17.1% test substance
- No. of animals per sex per dose:
- 9
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Positive control: mitomycin C1
- Route of administration: intraperitoneally
- Doses: 5 mg/kg - Tissues and cell types examined:
- bone marrow cells from femurs
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 3 animals were sacrificed at 6, 24, and 48 hrs after treatment. One group was exposed daily for 5 days prior to sacrifice.
DETAILS OF SLIDE PREPARATION: Cells were placed in Hank's solution, then centrifuged at 1000 rpm for 5 min. Supernatant was discarded, and 5 ml of 0.075 M KCl was added. The mixture then stood for 5 min., then was stirred and centrifuged again. This was repeated several times, before finally placing one or two drops on the slides, and staining with 2% Giemsa solution. - Evaluation criteria:
- Number of cells with chromatid and chromosome gaps, number of cells with aberrations.
50 metaphases per animal (150 total) were imaged at each time point. - Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No significant differences in the incidence of chromosomal aberrations were observed in any test substance treatment group relative to the controls.
- Conclusions:
- The test substance in not clastogenic.
- Executive summary:
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 commerical 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.
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Strain NMRI. Animals were approximately 22-26 g (male) and 20-25 g (female) and acclimated for 1 week to the test conditions (20±3 °C, 30-70% relative humidity, 12 hour light/dark cycle). Food was given daily and water was ad libitum. All animals were healthy at the time of test initiation.
- Route of administration:
- oral: gavage
- Vehicle:
- NaCl
- Duration of treatment / exposure:
- 72 hours
- Frequency of treatment:
- Single dose
- Dose / conc.:
- 1 122 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 40 males and 40 females per dose
- Control animals:
- yes
- Positive control(s):
- Endoxan (cyclophosphamid)
- Tissues and cell types examined:
- Cells were taken from the thigh.
- Details of tissue and slide preparation:
- Cells were mixed with cattle serum and suspended, then centrifuged. The sediment was then resuspended. The suspension was seperated in a cellulose chromatography column. This was centrifuged, and mixed with fetal calf serum and EDTA. This was air-dried for 24 hrs and stained with Giemsa.
- Evaluation criteria:
- number of polychromatid erythrocytes (PCE)
ratio of PCE to normochromatid erythrocytes (NCE)
number of cells with micronucleus - Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- No significant increases in the number of polychromatic erythrocytes with micronuclei were observed.
- Executive summary:
No significant increases in the number of polychromatic erythrocytes with micronuclei were observed.4
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- The in vivo genetic toxicity study of C10-13 LAS is based on read-across with C10-14 LAS. The read-across justification is presented in the assessment reports section. A cross-reference is made to that record.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Remarks:
- read-across justification
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Referenceopen allclose all
Dominant Lethal Assay Results
|
0.6% in Diet |
Control |
Number of mating females |
14 |
18 |
Number pregnant |
11 |
12 |
No. with dead embryos |
6 |
10 |
Dead embryos per pregnant female |
54.6% |
83.3% |
No. of corpora lutea |
156 |
161 |
Corpora lutea per pregnant female |
14.2 |
13.4 |
No. of implants |
148 |
156 |
Implants per pregnant female |
13.5 |
13.0 |
Implants per corpora lutea |
94.9 |
96.9 |
No. of live fetuses |
142 |
143 |
Live fetuses per pregnant female |
12.9 |
11.9 |
Live fetuses per corpora lutea |
91.0 |
88.8 |
Live fetuses per total implants |
96.0 |
91.7 |
No. of early dead fetuses |
4 |
12 |
No. of late dead fetuses |
2 |
1 |
% of dominant lethals |
-4.67 |
- |
% of dominant lethals |
-8.33 |
- |
Chromosome Aberrations
|
0.9% in Diet – Wister Rats |
0.9% in Diet – SD Rats |
Control |
Control |
No. of cells with chromatid breaks |
0 |
0 |
1 |
0 |
No. of cells with isochromatid breaks |
0 |
0 |
0 |
0 |
No. of cells with chromatid gaps |
3 |
4 |
3 |
4 |
No. of cells with isochromatid gaps |
0 |
0 |
0 |
0 |
No. of cells with other aberrations |
0 |
0 |
0 |
0 |
Chromosome Aberrations
|
0.9% in Diet |
Control |
No. of cells with chromatid breaks |
1 |
2 |
No. of cells with isochromatid breaks |
1 |
0 |
No. of cells with chromatid gaps |
4 |
5 |
No. of cells with isochromatid gaps |
0 |
0 |
No. of cells with other aberrations |
0 |
0 |
Chromosome Aberrations
|
Total number of cells having aberrations and occurrence (%) |
|||
|
6 hrs |
24 hrs |
48 hrs |
5 days |
200 mg/kg |
0 (0) |
0 (0) |
0 (0) |
1 (0.7) |
400 mg/kg |
1 (0.7) |
0 (0) |
0 (0) |
0 (0) |
800 mg/kg |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
800 mg/kg of 17.1% detergent |
0 (0) |
0 (0) |
0 (0) |
- |
1600 mg/kg of 17.1% detergent |
0 (0) |
1 (0.7) |
0 (0) |
- |
3200 mg/kg of 17.1% detergent |
2 (1.3) |
2 (1.3) |
0 (0) |
- |
1000 mg/kg of 19% detergent |
- |
0 (0) |
- |
- |
2000 mg/kg of 19% detergent |
- |
0 (0) |
- |
- |
4000 mg/kg of 19% detergent |
- |
0 (0) |
- |
- |
Mitomycin C |
16 (10.7) |
53 (353) |
13 (8.7) |
112 (74.7) |
Distilled water |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
untreated |
0 (0) |
0 (0) |
1 (0.7) |
0 (0) |
No significant increases in the number of polychromatic erythrocytes with micronuclei were observed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Genetic toxicity, in vitro
Study 1 - AMES - (C10-13 LAS):
A bacterial reverse mutation assay was conducted with C10-13 LAS, sodium salt to assess the potential mutagenicity of LAS. The experiment was run using S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, as well as TA1538 at test concentrations of 8, 40, 200, 1000 and 5000 µg/plate. All strains tested negative with and without S9 activation (Schoeberl, 1993).
Study 2 - OECD 476 - (C10-13 LAS):
An in vitro genetic toxicity study was conducted to evaluate the potential of C10 -13 LAS 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 µg/mL without metabolic activation (S9), and 0, 6, 10, 18, 30, and 60 µg/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 (Anon., 1995).
Study 3 - OECD 473 - (C10 -13 LAS):
An in vitro genetic toxicity study was conducted to evaluate the potential of the test substance to cause chromosomal aberrations in mammalian cells. Chinese hamster ovary cells were exposed to concentrations of 0.32 to 78 µg/mL with S9, and 1.25 to 156 µg/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 the test substance is weakly clastogenic at cytotoxic concentrations but negative at concentrations below cytotoxic concentrations (Murie & Innes, 1997).
Genetic toxicity, in vivo
Study 1 (C10-13 LAS):
An in vivo dominant lethal mutation assay was conducted with C10-13 LAS, sodium salt in male mice. 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. Under the study conditions, LAS was not mutagenic in mice (Masabuchi, 1976a).
Study 2 (C10-13 LAS):
An in vivo chromosomal aberration assay was conducted with C10-13 LAS, sodium salt in rats. In this study, groups of five male rats were fed diets containing 0.9% LAS for 9 months (equivalent to 405 mg/kg bw/day). 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 negative controls in either species but no positive controls have been included in this assay. Under the study conditions, LAS was not clastogenic in this assay (Masabuchi, 1976b).
Study 3 (C10 -13 LAS):
An in vivo chromosomal aberration assay was conducted with C10-13 LAS, sodium salt in male mice. In this study, groups of five male mice were fed diets containing 0.9% LAS for 9 months (equivalent to 1,125 mg/kg bw/day). 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 negative controls in either species but no positive controls have been included in this assay. Under the study conditions, LAS was not clastogenic in this assay (Masabuchi, 1976c).
Study 4 (C10-14 LAS):
An in vivo chromosomal aberration assay was conducted with C10-14 LAS, sodium salt in male mice. Groups of male mice were given doses of 200, 400, or 800 mg/kg bw of the test substance. At 6, 24, and 48 h, 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. 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. Under the study conditions, LAS was not clastogenic (Inoue, 1979).
Study 5 (10-13 LAS):
An in vivo micronucleus was conducted with C10-13 LAS acid in male and female mice (NMRI). Groups of 40 mice per sex were given a single dose of 1122 mg/kg bw test substance via oral gavage and evaluated for chromosome aberrations. Only a single dose has been evaluated which was in the range of the acute oral LD50 value for LAS Acid in rats (LD50 = 1470 mg/kg). Furthermore, slight cytotoxicity has been observed after 48 hours. No statistically significant or biologically relevant increases in the number of polychromatic erythrocytes with micronuclei were observed; therefore the test material is considered negative for cytogenicity (Fedtke, 1991)
Justification for classification or non-classification
Based on in vitro and in vivo genotoxicity studies conducted with LAS Na and its dissociation products no classification is warranted for this endpoint according to EU CLP (1272/2008/EC) criteria.
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