N-lauroylsarcosine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

03 May 1996 - 06 May 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. Lack on test material details and no TA102 or E. coli strain was included in the test.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

lack on test material details, no TA102 or E. coli strain was included.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium N-lauroylsarcosinate

EC Number:

205-281-5

EC Name:

Sodium N-lauroylsarcosinate

Cas Number:

137-16-6

IUPAC Name:

sodium [dodecanoyl(methyl)amino]acetate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Lot/batch No.: R00853.96
- Date received: 1996-0308

Method

Target gene:

his operon

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA1538, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.

Test concentrations with justification for top dose:

10, 100, 1000 and 10000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water
The material under examination was used following dilution in distilled water in an amount of 100 mg/mL.

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: sodium azide (5 µg/plate, -S9, TA1535 and TA100); 9-aminoacridine (40 µg/plate, -S9, TA1537); 2-nitrofluorene (10 µg/plate, -S9, TA 1538 and TA98); 2-acetylaminoflurorene (1 µg/plate, +S9, all strains)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: 24 h
- Exposure duration: 48-72 h
- Fixation time (start of exposure up to fixation or harvest of cells): 48-72 h

NUMBER OF REPLICATIONS: Three repetitions were carried out for the assay sample and two for the positive controls.

DETERMINATION OF CYTOTOXICITY
- Method: The toxicity of the assay sample for the mutant strains of Salmonella typhimurium was evaluated by planting the bacteria in the minimum medium and determining any reduction in the background lawn and in the number of spontaneous revertants caused by the assay sample at the maximum concentration tested.

Evaluation criteria:

CRITERIA FOR THE VALIDITY OF THE ASSAY
The S9 Mix must not be contaminated by more than two colonies per 0.5 mL in the sterility assay carried out following conclusion of the experiment on plates containing the full medium.
In the sterility assay carried out following conclusion of the experiment with the greatest concentration used, the assay sample must not be contaminated by more than two colonies per plate.
On average, the positive control must induce the development of revertant colonies in an amount at least three times greater than the negative control.
The number of spontaneous revertant colonies in the negative controls must lie within the following thresholds:

Strain: TA-1535
Threshold: 20 ± 15

Strain: TA-1538
Threshold: 20 ± 15

Strain: TA-1537
Threshold: 15 ± 10

Strain: TA-98
Threshold: 40 ± 25

Strain: TA-100
Threshold: 150 ± 90

Statistics:

Mean and standard deviation were calculated.

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

at 10000 µg/plate with and without metabolic activation

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

10000 µg/plate (with and without metabolic activation)

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1. Plate test without metabolic activation.

Strain	Plate	No. of revertant colonies/plate					Positive controls µg/plate
		ASSAY SAMPLE µg/plate
TA 1535		C	10	10^2	10^3	10^4	Na azide 5
	1	24	24	22	22	0	NC
	2	20	22	12	12	0	NC
	3	21	25	19	19	0	/
	average	21.7	23.7	17.7	17.7	/	/
	s.d.	2.08	1.53	5.13	5.13	/	/
TA 1537							9-AA 40
	1	5	13	10	9	0	222
	2	10	16	11	4	0	192
	3	12	13	15	10	0	/
	average	9	14	12	7.7	/	207
	s.d.	3.60	1.73	2.64	3.21	/	21.2
TA 1538							2-NF 10
	1	22	24	23	26	0	73
	2	21	40	34	24	0	97
	3	19	22	31	20	0	/
	average	20.7	21.7	29.3	23.3	/	85
	s.d.	1.53	9.86	5.67	3.05	/	16.97
TA 98							2-NF 10
	1	16	16	24	20	0	106
	2	23	22	23	10	0	107
	3	15	17	19	17	0	/
	average	18	18.3	22	15.7	/	106.5
	s.d.	4.36	3.21	2.64	5.13	/	0.71
TA 100							Na azide 5
	1	129	112	141	118	0	NC
	2	137	136	123	125	0	NC
	3	130	130	129	122	0	/
	average	132	126	131	122	/	/
	s.d.	4.36	12.48	9.16	3.51	/	/

Table 2. Plate test with metabolic activation. 

Strain	Plate	No. of revertant colonies/plate					Positive controls µg/plate
		ASSAY SAMPLE µg/plate
TA 1535		C-	10	10^2	10^3	10^4	2-AA 1
	1	10	10	28	15	3	160
	2	16	19	25	14	6	180
	3	18	20	19	9	7
	average	14.7	16.3	24	12.7	5.3
	s.d.	4.17	5.51	4.58	3.21	2.08
TA 1537							2-AA 1
	1	16	13	8	17	0	90
	2	18	18	15	10	0	110
	3	23	17	10	17	0	/
	average	19	16	11	14.7	/	100
	s.d.	3.60	2.64	3.60	4.04	/	14.14
TA 1538							2-AA 1
	1	17	29	8	9	0	NC
	2	13	15	14	12	0	NC
	3	14	17	17	20	0	/
	average	14.7	18.3	13	13.7	/	/
	s.d.	2.08	4.16	4.58	5.67	/	/
TA 98							2-AA 1
	1	15	12	5	10	2	154
	2	20	10	10	12	3	150
	3	19	15	16	15	4	/
	average	18	12.3	10.3	12.3	/	152
	s.d.	2.64	2.52	5.51	2.52	30	2.83
TA 100							2-AA 1
	1	240	125	175	137	1	NC
	2	200	156	174	360	0	NC
	3	176	168	174	180	0	/
	average	205.3	149.7	174.3	225.7	0.33	/
	s.d.	32.33	22.19	0.58	118.3	0.58	/

N.C.: no explanation given in the study report. However, all positive controls resulted in a significant increase in the number of revertants.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative