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EC number: 236-942-6 | CAS number: 13557-75-0
- 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
The genetic toxicity potential of the test item sodium lauroyl lactylate was assessed with three in vitro genetic toxicity studies: a bacterial reverse mutation assay (performed in accordance with OECD test guideline 471), a mammalian chromosome aberration test (OECD test guideline 473) and a gene mutation study in mammalian cells (OECD test guideline 476 using a suitable read-across substance sodium isostearoyl lactylate). In all three studies, there are no indications of genetic toxicity potential of the test item as well as its read-across substance. Taking the results in a weight-of-evidence approach, there is no genetic toxicity potential of sodium lauroyl lactylate.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1992-12-02 to 1993-03-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: For six months from November 1992
- Purity test date: Not available
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 °C in the dark, desiccated
- Stability under test conditions: Beige paste - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Test concentrations with justification for top dose:
- 0, 5, 15, 50, 150, 500, 1500, 5000 μg/plate
In the preliminary dose range finding study with dose levels of up to 5000 μg/plate toxicity was observed. 5000 μg/plate was chosen for the subsequent mutation study as the top dose. - Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- yes
- Remarks:
- water
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation)
DURATION
- Pre-incubation period: 24 hours
- Exposure duration: 3 days
DETERMINATION OF CYTOTOXICITY
- Method: Observation of reduction in background bacterial lawn
Individual revertant colony plate counts were gathered. - Statistics:
- No statistical analysis performed.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Without S-9 mix between 5000-500 μg/plate, with S-9 at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In the presence and absence of S-9 mix between 5000-500 μg/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In the presence and absence of S-9 mix between 5000-150 μg/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Pationic 138C shows no evidence of mutagenic activity in the bacterial reverse mutation assay.
- Executive summary:
Pationic 138C shows no evidence of mutagenic activity in the bacterial reverse mutation assay. The test was performed with and without liver preparations from Aroclor 1254 -induced rats. The test was performed according to OECD guideline 471.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-11-20 until 1993-07-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch no. of test material: Unilever sample number S1986201
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Desiccated and refrigerated in the dark
- Stability under test conditions: Not specified
- Solubility and stability of the test substance in the solvent/vehicle: 0.24 mg/mL in culture medium
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test chemical stock solution was prepraed by dissolving Pationic 138C in culture medium (with warming at 37 °C) to give 266.7 µg/mL. Then solution was membrane filter-sterilized and dilutions made in glass containers using culture medium. The test chemical solutions were protected from light and used within 1.5 hours of initial dissolution.
- Final dilution of a dissolved solid, stock liquid or gel: 266.7 µg/mL
FORM AS APPLIED IN THE TEST (if different from that of starting material) : in solution form for test; arrived as a beige paste. - Species / strain / cell type:
- lymphocytes:
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Healthy, nonsmoking volunteer
- Suitability of cells: not specified
- Cell cycle length, doubling time or proliferation index:
- Sex, age and number of blood donors if applicable: female
- Whether whole blood or separated lymphocytes were used if applicable: whole blood
- Methods for maintenance in cell culture if applicable: blood was refrigerated during storage. Whole blood cultures were established in sterile disposable centrifuge tubes by placing 0.4 mL heparinised blood into culture media, rocked continuously during incubation
- Modal number of chromosomes:
- Normal (negative control) cell cycle time:
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: Hepes-buffered RPMI medium containing 20% (v/v) fetal calf serum and 50 ug/mL genatmycin. Phytohaemagglutinin (PHA, reagent grade) was included at a concentration of 37.5 uL per mL of culture to stimulate lymphocyte division.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: not specified
- Periodically checked for karyotype stability: not specified
- Periodically 'cleansed' against high spontaneous background: not specified - Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9
- Test concentrations with justification for top dose:
- 10.76, 15.37, 21.96, 31.37, 44.82, 64.03, 91.47, 130.7, 186.7, 266.7 µg/mL
TOP DOSE: At which a 50-80 % reduction in mitotic index occurred, a concentration close to the solubility limit in the treatment medium or 10 mM (or 5000 µg/mL), whichever was the lower. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: none
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- culture medium
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In medium
DURATION
- Preincubation period: 48 hours
- Exposure duration: 20 hours
- Expression time (cells in growth medium): 3 hours with S9
- Fixation time (start of exposure up to fixation or harvest of cells): 37 hours
SPINDLE INHIBITOR (cytogenetic assays): Colchicine
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2 per dose, with and without S9
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: Lymphocytes were kept in fixative in the refrigerator at approx. 4 °C before slides were prepared. Cells were pelleted and resuspended in a minimal amoung of fresh fixative (milky suspension was the goal). Several drops of 45 % (v/v) aqueous acetic acid were added to each suspension to enhance chromosome spreading, and several drops of suspension were dropped on to clean microscope slides which had been dipped in water. After the slides had dried, the cells were stained for 5 minutes in 4 % (v/v) filtered Giemsa stain in pH 6.8 buffer. Slides were rinsed, dried, and mounted with coverslips.
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): 100 metaphases per culture. Only cells with 44-46 chromosomes were considered acceptable for analysis of structural aberrations.
OTHER EXAMINATIONS:
- Determination of polyploidy: Any cell with more than 46 chromosomes were noted and recorded separately
- Determination of endoreplication: Any cell with more than 46 chromosomes were noted and recorded separately - Rationale for test conditions:
- The human lymphocyte assay was valid if the following criteria were met:
1) The bionomial dispersion test demonstrated acceptable heterogeneity between replicate cultures
2) The proportion of cells with structural aberrations (excluding gaps) in negative control cultures fell within the normal range
3) At least 160 cells out of an intended 200 were analysable at each treatment level
4) The positive control chemicals induced statistically significant increases in the number of cells with structural aberrations - Evaluation criteria:
- The test chemical was to be considered as clearly positive in this assay if:
1) Statistically significant increases in the proportion of cells with structural aberrations (excluding gaps) occurred at one or more concentrations
2) The proportion of aberrant cells at such data points exceeded the normal range.
Increases in numbers of cells with gaps or increases in the proportions of cells with structural aberrations within the normal range or occurring only at very high or very toxic concentrations were likely to be concluded as equivocal. Cells with exchange aberrations or cells with greater than one aberration were to be considered of particular biological significance. - Statistics:
- The proportion of cells in category 2 for each test treatment condition were compared with the proportion in negative controls using Fisher's exact test. Probability values of p ≤ 0.05 were accepted as significant.
- Key result
- Species / strain:
- lymphocytes: Human
- Remarks:
- Single female healthy non-smoking volunteer
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Remarks:
- same as vehicle control
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: 0.24 mg/mL in test medium
- Definition of acceptable cells for analysis: 44-46 chromosomes
HISTORICAL CONTROL DATA
- Positive historical control data: not given
- Negative (solvent/vehicle) historical control data - mean (range):
- structural aberrations including gaps: 2.2 (0-8) without S9; 2.5 (0-8) with S9
- structural aberrations excluding gaps: 0.5 (0-3) without S9; 0.9 (0-4) with S9
- numerical aberrations: 0.6 (0-3) without S9; 0.7 (0-3) with S9 - Conclusions:
- Sodium lauroyl lactylate (Pationic 138C) did not induce chromosome aberrations in cultured human peripheral blood lymphocytes when tested to its limit of solubility in both the absence and presence of S-9.
- Executive summary:
In a test following OECD guideline 473 (in vitro mammalian chromosome aberration test), human lymphocyte cultures treated with sodium lauroyl lactylate (Pationic 138C) in both the absence and presence of S9 had frequencies of cells with aberrations which were similar to and not significantly different from those in concurrent solvent controls. Numbers of aberrant cells fell within historical negative control ranges under all treatment conditions. Therefore, in this test system sodium lauroyl lactylate is not identified as genotoxic.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At the highest tested concentration for mutagenicity (75 µg/mL)
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At the highest tested concentration for mutagenicity (14 µg/mL)
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: In the first pre-experiment eight concentrations [250, 500, 600, 700, 800, 1000, 1500 and 2000 µg/mL] were tested. Due to very high toxicity, the pre-experiment had to be repeated with lower concentrations (1–250 µg/mL), which then allowed selection of the concentrations to be tested in the main experiments.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95 %): See Table 5 in “any other information on materials and methods”. - Conclusions:
- In an in vitro cell gene mutagenicity test, the test item sodium isostearoyl lactylate is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese hamster.
- Executive summary:
The test item sodium isostearoyl lactylate was assessed for its potential to induce mutations at the HPRT locus using V79 cells of the Chinese hamster. The selection of the concentrations was based on data from the pre-experiments. The main experiments with and without metabolic activation were performed as a 4 h short-term exposure assay. Cytotoxicity was tested in the main experiment at the ranges of 2–20 µg/mL without metabolic activation and 25–90 µg/mL with metabolic activation. The mutagenicity of the test item was investigated at the following concentrations: without metabolic activation: 4, 6, 8, 10 and 14 µg/mL and with metabolic activation: 25, 55, 65 and 75 µg/mL No precipitation of the test item was noted in the experiments.
Biologically relevant growth inhibition (i.e. relative survival < 70 %) was observed in the experiment with and without metabolic activation. In the experiment without metabolic activation the relative survival was 10 % for the highest concentration (14 µg/mL) evaluated for mutagenicity. The highest biologically relevant concentration evaluated for mutagenicity with metabolic activation was 75 µg/mL with a relative survival of 15 %.
In the experiments no biologically relevant increase of mutants (i.e. above the upper limit of the historical control data) was found after treatment with the test item (without and with metabolic activation) and no concentration-response relationship was observed. DMBA and EMS were used as positive controls and showed distinct and biologically relevant effects in mutation frequency.
Thus, in this in vitro cell gene mutagenicity test, the test item sodium isostearoyl lactylate is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese hamster.
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
Referenceopen allclose all
Following treatment with Pationic 138C toxicity was observed in the absence of S-9 mix towards TA 1537 and TA 98 between 5000 and 500 μg/plate, and towards TA 100 between 5000 and 150 μg/plate. Toxicity was also observed in the presence of S-9 mix towards TA 1537 at 5000 μg/plate (10 % S-9 fraction), towards TA 98 between 5000 and 500 μg/plate (10% S-9 fraction) and between 5000 and 1500 μg/plate (30@ S-9 fraction), and towards TA 100 between 5000 and 150 μg/plate (10%-30% S-9 fractions).
Following treatment with Pationic 138C toxicity was observed towards TA 1537 in the absence of S-9 mix between 5000 and 1500 μg/plate and in the presence of S-9 mix at 5000 μg/plate, towards TA 98 between 5000 and 500 μg/plate in the presence and absence of S-9 mix, and towards TA 100 and 5000 and 150 μg/plate in the presence and absence of S-9 mix. No substantial increases in revertant colony numbers of any of the tester strains were observed following treatment with Patrionic 138C at any dose level, either in the presence of absence of S-9 mix.
The concurrent positive control compounds demonstrated the sensitivity of the assay and the metabolizing activity of the liver preparations.
VALIDITY OF STUDY
The data confirm that:
1) No evidence of significant heterogeneity between replicate cultures was obtained in the binomial dispersion test
2) The proportion of cells with structural aberrations (excluding gaps) in negative control cultures fell within the normal range
3) At least 160 cells out of an intended 200 were analysed at each treatment level
4) The positive control chemicals NQO and CPA induced statistically significant increases in the number of cells with structural aberrations.
A small increase in cells with numerical aberrations was observed in one treated culture but only in one of the pair of replicates and was considered spurious.
Table 1: Cytotoxicity, without metabolic activation
Group |
Concen-tration [µg/mL] |
Number of cells at the |
Number of colonies per flaska |
CEb [%] |
Adjusted CEc [%] |
Relative Survival (RS)d [%] |
|||||
beginning of treatment |
end of treatment |
I |
II |
mean | |||||||
NC1 |
0 |
10000000 |
9996000 |
161 |
156 |
159 |
79 |
79 |
100 |
||
NC2 |
10000000 |
10693000 |
137 |
167 |
152 |
76 |
81 |
||||
1 |
2 |
10000000 |
10540000 |
192 |
189 |
191 |
95 |
100 |
125 |
||
2 |
4 |
10000000 |
10812000 |
162 |
175 |
169 |
84 |
91 |
114 |
||
3 |
6 |
10000000 |
10523000 |
169 |
143 |
156 |
78 |
82 |
102 |
||
4 |
8 |
10000000 |
8823000 |
127 |
125 |
126 |
63 |
56 |
69 |
||
5 |
10 |
10000000 |
6817000 |
63 |
53 |
58 |
29 |
20 |
25 |
||
6 |
14 |
20000000 |
6358000 |
46 |
51 |
49 |
24 |
8 |
10 |
||
7 |
16 |
20000000 |
4148000 |
70 |
59 |
65 |
32 |
7 |
8 |
||
8 |
20 |
20000000 |
2754000 |
77 |
81 |
79 |
40 |
5 |
7 |
||
EMS |
300 |
10000000 |
11577000 |
163 |
170 |
167 |
83 |
96 |
120 |
NC: negative control
CE: cloning efficiency
EMS: ethyl methanesulfonate
a: number of cells plated: 200 cells/flask
b: cloning efficiency: CE [%] = [(number of colonies / number of cells plated) x 100]
c: adjusted CE [%] = [CE x (number of cells at the end of treatment / number of cells at the beginning of treatment)]
d: relative survival: RS [%] = [(adjusted CE in treated culture / adjusted CE in the negative control) x 100]
Table 2: Mutagenicity, without metabolic activation
|
CE in non-selective medium |
CE in selective medium |
|
|||||||||||
Group |
Concen-tration [µg/mL] |
Number of colonies per flaska |
CEb [%] |
Number of colonies per flaskc |
CEb[%] |
Mutant Frequency per 106cellsd |
||||||||
I |
II |
mean |
I |
II |
III |
IV |
V |
mean |
SD |
|||||
NC1 |
0 |
168 |
163 |
166 |
83 |
13 |
8 |
11 |
12 |
8 |
10.4 |
2.1 |
0.0026 |
31.4 |
NC2 |
150 |
160 |
155 |
78 |
8 |
13 |
13 |
11 |
14 |
11.8 |
2.1 |
0.0030 |
38.1 |
|
S1 |
0 |
168 |
163 |
166 |
83 |
13 |
8 |
11 |
12 |
8 |
10.4 |
2.1 |
0.0026 |
31.4 |
S2 |
150 |
160 |
155 |
78 |
8 |
13 |
13 |
11 |
14 |
11.8 |
2.1 |
0.0030 |
38.1 |
|
2 |
4 |
150 |
165 |
158 |
79 |
9 |
7 |
11 |
8 |
8 |
8.6 |
1.4 |
0.0022 |
27.3 |
3 |
6 |
143 |
161 |
152 |
76 |
11 |
14 |
6 |
16 |
8 |
11.0 |
3.7 |
0.0028 |
36.2 |
4 |
8 |
171 |
150 |
161 |
80 |
7 |
13 |
10 |
9 |
6 |
9.0 |
2.4 |
0.0023 |
28.0 |
5 |
10 |
161 |
175 |
168 |
84 |
9 |
7 |
8 |
4 |
6 |
6.8 |
1.7 |
0.0017 |
20.2 |
6 |
14 |
138 |
146 |
142 |
71 |
11 |
10 |
11 |
13 |
14 |
11.8 |
1.5 |
0.0030 |
41.5 |
EMS |
300 |
155 |
165 |
160 |
80 |
60 |
75 |
76 |
76 |
77 |
72.8 |
6.4 |
0.0182 |
227.5 |
NC: negative control
CE: cloning efficiency
EMS: ethyl methanesulfonate
a: number of cells plated: 200 cells/flask
b: cloning efficiency:CE [%] = [(number of colonies / number of cells plated) x 100]
c: number of cells plated: 400000 cells/petri dish
d: mutant frequency (per 106cells): MF = [CE of mutant colonies in selective medium / CE in non-selective medium) x 106]
Table 3: Cytotoxicity, with metabolic activation
Group |
Concen-tration [µg/mL] |
Number of cells at the |
Number of colonies per flaska |
CEb [%] |
Adjusted CEc [%] |
Relative Survival (RS)d [%] |
|||||
beginning of treatment |
end of treatment |
I |
II |
mean |
|||||||
NC1 |
0 |
10000000 |
13991000 |
113 |
132 |
123 |
61 |
86 |
100 |
||
NC2 |
10000000 |
13566000 |
148 |
148 |
148 |
74 |
100 |
||||
1 |
25 |
10000000 |
12563000 |
153 |
141 |
147 |
74 |
92 |
99 |
||
2 |
50 |
10000000 |
13549000 |
108 |
114 |
111 |
56 |
75 |
81 |
||
3 |
55 |
10000000 |
13566000 |
109 |
103 |
106 |
53 |
72 |
77 |
||
4 |
60 |
10000000 |
4471000 |
28 |
29 |
29 |
14 |
6 |
7 |
||
5 |
65 |
10000000 |
13634000 |
114 |
93 |
104 |
52 |
71 |
76 |
||
6 |
70 |
10000000 |
8755000 |
35 |
38 |
37 |
18 |
16 |
17 |
||
7 |
75 |
20000000 |
12070000 |
31 |
63 |
47 |
24 |
14 |
15 |
||
8 |
80 |
20000000 |
9520000 |
31 |
41 |
36 |
18 |
9 |
9 |
||
9 |
85 |
20000000 |
7344000 |
37 |
37 |
37 |
19 |
7 |
7 |
||
10 |
90 |
20000000 |
7242000 |
14 |
21 |
18 |
9 |
3 |
3 |
||
DMBA |
1.0 |
10000000 |
14484000 |
142 |
145 |
144 |
72 |
104 |
112 |
||
DMBA |
1.5 |
10000000 |
14484000 |
146 |
142 |
144 |
72 |
104 |
112 |
NC: negative control
CE: cloning efficiency
DMBA: 7,12-dimethylbenz(a)anthracene
a: number of cells plated: 200 cells/flask
b: cloning efficiency: CE [%] = [(number of colonies / number of cells plated) x 100]
c: adjusted CE [%] = [CE x (number of cells at the end of treatment / number of cells at the beginning of treatment)]
d:
relative
survival: RS
[%] = [(adjusted CE in treated culture / adjusted CE in the negative
control) x 100]
Table 4: Mutagenicity, with metabolic activation
|
CE in non-selective medium |
CE in selective medium |
|
|||||||||||
Group |
Concen-tration [µg/mL] |
Number of colonies per flaska |
CEb[%] |
Number of colonies per flaskc |
CEb [%] |
Mutant Frequency per 106cellsd |
||||||||
I |
II |
mean |
I |
II |
III |
IV |
V |
mean |
SD |
|||||
NC1 |
0 |
155 |
137 |
146 |
73 |
9 |
7 |
9 |
13 |
3 |
8.2 |
3.2 |
0.0021 |
28.1 |
NC2 |
146 |
140 |
143 |
72 |
13 |
7 |
10 |
11 |
7 |
9.6 |
2.3 |
0.0024 |
33.6 |
|
1 |
25 |
143 |
128 |
136 |
68 |
11 |
7 |
13 |
14 |
5 |
10.0 |
3.5 |
0.0025 |
36.9 |
3 |
55 |
156 |
178 |
167 |
84 |
13 |
15 |
16 |
10 |
9 |
12.6 |
2.7 |
0.0032 |
37.7 |
5 |
65 |
167 |
181 |
174 |
87 |
16 |
20 |
11 |
12 |
6 |
13.0 |
4.7 |
0.0033 |
37.4 |
7 |
75 |
167 |
163 |
165 |
83 |
15 |
12 |
8 |
14 |
8 |
11.4 |
2.9 |
0.0029 |
34.5 |
DMBA |
1.0 |
167 |
144 |
156 |
78 |
89 |
110 |
96 |
103 |
110 |
101.6 |
8.2 |
0.0254 |
326.7 |
DMBA |
1.5 |
158 |
147 |
153 |
76 |
121 |
100 |
114 |
121 |
116 |
114.4 |
7.7 |
0.0286 |
375.1 |
NC: negative control
CE: cloning efficiency
DMBA: 7,12-dimethylbenz(a)anthracene
a: number of cells plated: 200 cells/flask
b: cloning efficiency: CE [%] = [(number of colonies / number of cells plated) x 100]
c: number of cells plated: 400000 cells/petri dish
d: mutant frequency (per 106cells): MF = [CE of mutant colonies in selective medium / CE in non-selective medium) x 106]
Table 5: Historical Laboratory Control Data (January 2015 – April 2018)
|
Negative Control |
Positive Control |
||
|
-S9 |
+S9 |
EMS |
DMBA |
Mean |
24 |
27 |
290 |
414 |
Min |
5 |
8 |
186 |
117 |
Max |
43 |
49 |
631 |
788 |
SD |
7.92 |
8.60 |
71.86 |
170.31 |
RSD [%] |
32.51 |
32.12 |
24.74 |
41.15 |
n = |
64 |
70 |
63 |
62 |
LCL |
8.5 |
9.6 |
146.7 |
73.2 |
UCL |
40.2 |
44.0 |
434.2 |
754.4 |
NC: negative control
PC: positive controls (-S9 EMS; +S9 DMBA)
S9: metabolic activation
Mean: mean of mutants/106cells
Min.: minimum of mutants/106cells
Max.: maximum of mutants/106cells
SD: standard deviation
RSD: relative standard deviation
n: number of control values
LCL: lower control limit
UCL: upper control limit
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
In vivo genetic toxicity testing was not necessary based on negative in vitro test results.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Genetic toxicity potential of test item sodium lauroyl lactylate was assessed in three different genetic toxicity tests (all performed in accordance with OECD test guideline for genetic toxicity testing) using the test item as well as its read-across substance sodium isostearoyl lactylate. All three studies showed no genetic toxicity potential of the test item as well as the read-across substance. Based on the outcomes of these studies, there is no genetic toxicity concern of sodium lauroyl lactylate taking a weight-of-evidence approach. Therefore, classification for mutagenicity is not warranted under CLP.
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