Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-09 to 1996-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

26 th May, 1983

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

EC Number:

946-420-6

Molecular formula:

not applicable

IUPAC Name:

Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

Test material form:

liquid: viscous

Method

Target gene:

Histidine locus

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

The test concentrations were: 0, 8, 40, 200, 1000 and 5000 µg/plate based on the results from the dose range finding test.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility of the test substance and low amount of spontaneous revertants within the control.

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

cumene hydroperoxide

other: 2-Aminoanthracene (with S9)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable):1E09 cells/plate

DURATION
- Exposure duration: 65 h

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: background bacterial lawn

Evaluation criteria:

A positive result is indicated by a dose response with statistically significant increases in revertant numbers

Statistics:

Mean standard deviations and Dunnett´s t-statistic

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

cytotoxic at 5000 µg/plate without S9, not cytotoxic with S9 up to limit concentration

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Any other information on results incl. tables

Table 1:Number of revertants per plate (mean of 3 plates)

	[strain 1535]		[strain 1537]		[strain 102]		[strain 98]		[strain 100]
Conc. [µg/plate]	— MA	+ MA	— MA	+ MA	— MA	+ MA	— MA	+ MA	— MA	+ MA
0*	8.3	11.7	8.0	6.0	228.7	209.0	19.3	44.0	81.3	90.0
8	15.3	11.7	9.3	7.5	229.7	259.0	22.0	40.0	91.0	91.3
40	12.7	8.7	10.0	8.0	215.7	253.7	21.0	34.7	100.7	84.0
200	18.7	9.7	7.0	11.5	192.7	214.3	27.3	31.3	93.7	91.7
1000	10.3	14.5	7.0	12.3	163.7	161.0	19.3	31.5	89.0	90.0
5000	b	5.0	b	3.0	a	89.3	b	20.3	a	64.7
Positive control	325.0	70.3	173.3	27.0	307.3	418.0	138.0	221.0	415.7	362.7

*solvent control with DMSO

b = Complete loss of lawn

a = Reduced lawn.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this Ames test, polyglycerin caprinate was negative for mutagenic potential.

Executive summary:

In a reverse gene mutation assay in bacteria according to OECD guideline 471 (adopted 21 July 1997), Salmonella typhimurium strains TA 1535, TA 1537, TA 102, TA 98 and TA 100 were exposed to polyglycerin caprinate in DMSO in concentrations of 0 (control), 8, 40, 200, 1000 and 5000 µg/plate in all strains in the presence and absence of mammalian metabolic activation (rat liver S9 mix). The assay was performed using the plate incorporation method.

The test substance was tested up to limit concentrations. Cytotoxic effects (reduced background lawn) were noted at 5000 µg/plate without S9; no cytotoxicity was observed with S9 up to the limit concentration. The positive controls induced the appropriate responses in the corresponding strains.

There was no evidence of a statistically significant increase in the number of revertant colonies in any of the five tester strains. Therefore, test substance was considered to be non-genotoxic (non-mutagenic) in Salmonella tester strains TA 1535, TA 1537, TA 102, TA 98 and TA 100 under the conditions employed (plate incorporation assay).

There was no evidence of induced mutant colonies over background. Under the conditions of the study, the test substance was negative for mutagenic potential.