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EC number: 266-533-8 | CAS number: 66988-04-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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 isostearoyl lactylate was assessed with three in vitro genetic toxicity studies: One gene mutation study in mammalian cells (HPRT; performed in accordance with OECD 476 using the test item) and two genetic toxicity studies (an Ames assay in bacteria and a chromosomal aberration test in mammalian cells) using calcium stearoyl lactylate, a suitable read-across substance for the test item. 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 isostearoyl lactylate.
For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration 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:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not valid
- Conclusions:
- Interpretation of results: Negative
The test substance showed no genetic toxicity when tested on Chinese hamster lung fibroblast mammalian cell line. - Executive summary:
In a mammalian cell cytogenetics assay (chromosome aberration test), primary lung fibroblast cultures were exposed to calcium stearoyl-2-lactylate in ethanol at a concentration of 0.063 mg/ml without metabolic activation.
Calcium stearoyl-2-lactylate was tested up to cytotoxic concentrations (50 % cell-growth inhibition). Positive controls were not included.
This study is classified as partly acceptable. This study partly satisfies the requirements for test guideline OECD 473 for in vitro cytogenetic mutagenicity data.
In this study, the test item is non-mutagenic.
This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Endpoint:
- in vitro gene mutation study in bacteria
- 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 report attached in section 13 of IUCLID.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium, other: TA92, TA1535, TA100, TA1537, TA94 and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not valid
- Conclusions:
- Interpretation of results: Negative
The test substance showed no genetic toxicity when tested in S. typhimurium TA92, TA1535, TA100, TA1537, TA94 and TA98. - Executive summary:
In a reverse gene mutation assay in bacteria, strains TA92, TA1535, TA100, TA1537, TA94 and TA98of S. typhimurium were exposed to calcium stearyl-2-lactylatein benzene as solventat a concentration of 0.3 mg/plate in the presence and absence of mammalian metabolic activation.
Calcium stearyl-2-lactylate was tested up to insoluble concentrations using a co-solvent. Positive control results were not reported.
This study is classified asacceptable. This study satisfies the requirement for OECD test guideline 471 for in vitro mutagenicity (bacterial reverse gene mutation) data. The absence of strains sensitive to certain oxidising mutagens, cross-linking agents and hydrazines is not considered a major deficiency since the test substance obviously does not belong to these substance classes. The lack of positive controls is considered a minor deficiency not invalidating this study.
This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-02-12 to 2018-10-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- Adopted July 29, 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch no. of test material: Pationic ISL (Lot: 1731200025)
- Expiration date of the lot/batch: 12 months after opening
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Solubility and stability of the test substance in the solvent/vehicle: All test item solutions were freshly prepared immediately prior to use.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: A solubility test was performed with different solvents and vehicles. Based on the results of the solubility test, treatment medium (MEM + 0% FBS) was used as solvent. The solvent was compatible with the survival of the cells and the S9 activity. The pH-value detected with the test item was within the physiological range (pH 7.0 ± 0.4). Osmolality of the highest test item concentration was 324 mOsmol/kg. - Target gene:
- Hprt
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: ATCC (CCL-93)
- Suitability of cells: These cells are characterised by their high proliferation rate and their high cloning efficiency of untreated cells (usually more than 50%). These features of the cells are necessary for the appropriate performance of the study.
- Cell cycle length, doubling time or proliferation index: 12 - 14 h doubling time
- Methods for maintenance in cell culture: Freshly thawed cells from stock cultures were maintained in plastic culture flasks in minimal essential medium (MEM) and cultured at a humidified atmosphere of 5% CO2 and at 37 °C.
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: MEM supplemented with 10% (v/v) fetal bovine serum (FBS), 100 U/100 µg/mL penicillin/streptomycin, 2 mM L-glutamine, 25 mM HEPES and 2.5 µg/mL amphotericin B; cultured at a humidified atmosphere of 5% CO2 and at 37 °C
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically 'cleansed' against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver
- Test concentrations with justification for top dose:
- Cytotoxicity of the test item was determined in a pre-experiment. In the pre-experiment it was observed that cytotoxic effects occurred without metabolic activation at concentrations of 10 µg/mL or higher and with metabolic activation at concentrations of 100 µg/mL or higher. Based on these data the concentrations for the main experiment were selected.
The test item was tested for cytotoxicity at the following concentrations:
* without metabolic activation: 2, 4, 6, 8, 10, 14, 16 and 20 µg/mL
* with metabolic activation: 25, 50, 55, 60, 65, 70, 75, 80, 85 and 90 µg/mL
According to OECD test guideline 476, more than 4 concentrations may be particularly important for evaluating mutagenicity when using single cultures. Therefore, the following 5 concentrations were selected on the basis of cytotoxicity for evaluating mutagenicity.
* without metabolic activation: 4, 6, 8, 10 and 14 µg/mL
* with metabolic activation: 25, 55, 65, 75 and 85 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: treatment medium (MEM + 0 % FBS)
- Justification for choice of solvent/vehicle: A solubility test was performed with different solvents and vehicles. Based on the results of the solubility test, the treatment medium was used as solvent. The solvent was compatible with the survival of the cells and the S9 activity. - Untreated negative controls:
- yes
- Remarks:
- Treatment medium
- Negative solvent / vehicle controls:
- no
- Remarks:
- Not required as treatment medium was used as vehicle for test item.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
- Cell density at seeding: Approximately 10–20E+06 cells per each concentration, negative and positive controls, were seeded in complete cell culture medium (MEM supplemented with 10 % FBS) in a 175 cm³ culture flask.
DURATION
- Preincubation period: 24 h after seeding
- Exposure duration: 4 h
- Expression time (cells in growth medium): 7–9 days after treatment
- Selection time (if incubation with a selection agent): 9–11 days for mutant frequency and 6–8 days for cloning efficiency
SELECTION AGENT (mutation assays): 11 µg/mL 6-thioguanine (TG)
NUMBER OF REPLICATIONS: 2 for cytotoxicity; 2–5 for mutagenicity
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: Colonies were fixed with methanol, stained with Giemsa and counted.
NUMBER OF CELLS EVALUATED: 200 cells for cloning efficiency and 400000 cells for mutagenicity
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency
- Any supplementary information relevant to cytotoxicity: The relative survival (indicator of cytotoxicity) was calculated based on the cloning efficiency of the cells plated immediately after treatment adjusted by any loss of cells during treatment. - Evaluation criteria:
- A test chemical is considered to be clearly negative if, in all experimental conditions examined,
- none of the test concentrations exhibits a statistically significant increase compared with the concurrent negative control,
- there is no concentration-related increase when evaluated with an appropriate trend-test, and
- all results are inside the distribution of the historical negative control data.
A test chemical is considered to be clearly positive if, in any of the experimental conditions examined,
- at least one of the test concentrations exhibits a statistically significant increase compared with the concurrent negative control,
- the increase is concentration-related when evaluated with an appropriate trend test, and
- any of the results are outside the distribution of the historical negative control data.
- if there is by chance a low spontaneous mutation rate in the corresponding negative control a concentration-related increase of the mutations within their range has to be discussed.
According to the OECD guideline, the biological relevance is considered first for the interpretation of results. - Statistics:
- The non-parametric Mann-Whitney test was applied to the mutation data to determine any significant difference in mutant frequency for the concentration groups when compared to the negative control. Mutant frequencies of the negative control were used as reference. Additionally, the chi-squared test for trend was conducted to determine a statistically significant concentration-response relationship.
- 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.
Referenceopen allclose all
Cytotoxicity: A biologically relevant growth inhibition (i.e. reduction of relative survival below 70%) was observed after the treatment with the test item 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 in the mutagenicity experiment with metabolic activation was 75 µg/mL with a relative survival of 15%. At concentration of 60 µg/mL the relative survival value was decreased (RS = 7%) but was considered to be an outlier in comparison to the next lower (55 µg/mL, RS = 77%) and the next higher (65 µg/mL; RS = 76%) tested concentrations. As the next lower and higher concentrations showed no cytotoxicity, this decrease was regarded as not biologically relevant and potentially caused by technical reasons.
Mutagenicity: In the experiments no biologically relevant increase of mutants (i.e. above the upper limit of the historical control data and no statistically relevant increase) was found after treatment with the test item (without and with metabolic activation). In the experiment without metabolic activation one mutant value (at concentration 14 µg/mL with 41.5 mutants/106cells) was found to be slightly above the upper limit of the historical control data (40.2 mutants/106cells). However, at this concentration, the relative survival is 10% and this positive result, according to the OECD guideline 476, should be interpreted with caution. Since this was only a slight increase and no statistically significant increase was determined, this effect was considered as not biologically relevant. All the other mutant values were within the historical control data range of the test facility.
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 |
|
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 genotoxicity 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
The genetic toxicity potential of test item sodium isostearoyl lactylate was assessed in three different genetic toxicity tests, one performed with the test item in accordance with OECD 476 and two performed with calcium stearoyl lactylate (suitable read-across substance of the test item). 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 isostearoyl lactylate taking a weight-of-evidence approach. Therefore, classification for mutagenicity is not warranted under CLP.
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