Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl laurate

Endpoint summary

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

Reference

Reference 1

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

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.

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.

Reference 2

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

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.

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.

Reference 3

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”.

Table 1: Cytotoxicity, without metabolic activation

Group		Concen-tration [µg/mL]	Number of cells at the		Number of colonies per flask^a			CE^b[%]	Adjusted CE^c [%]	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 flask^a			CE^b[%]	Number of colonies per flask^c							CE^b[%]	Mutant Frequency per 10^6cells^d
		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 flask^a			CE^b[%]	Adjusted CE^c [%]	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 flask^a			CE^b[%]	Number of colonies per flask^c							CE^b [%]	Mutant Frequency per 10^6cells^d
		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

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.

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

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.