Sorbitan monostearate, ethoxylated

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Gene mutation toxicity study of the test chemical

Author:

Inoue et al

Year:

1980

Bibliographic source:

Food and chemical toxicology

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan monostearate, ethoxylated

Cas Number:

9005-67-8

Molecular formula:

C64H126O26

IUPAC Name:

Sorbitan monostearate, ethoxylated

Details on test material:

- Name of test material: Polyoxyethylene sorbitan
monostearate (Tween 60)
- IUPAC name: Sorbitan monostearate, ethoxylated
- Molecular formula: C64H126O26
- Molecular weight: 606.8318 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98 and TA100

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

S9 metabolic activation system

Test concentrations with justification for top dose:

0, 10, 100, 200, 1000 or 2000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

benzo(a)pyrene

other: N-Methyl-N’-nitro-N-nitrosoguanidine, 2-Acetylaminofluorene, N-Nitrosodimethylamine

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: No data

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: No data

Rationale for test conditions:

No data

Evaluation criteria:

The plates were observed or a dose dependent increase in the number of revertants/plate

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98 and TA100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

No data

Remarks on result:

other: No mutagenic potential

Any other information on results incl. tables

Table 1. Mutagenicity of the test compound and the respective control chemicals

Compound	Dose (µg/plate)	No. of His+ revertants/plate
		TA100		TA98
		-S9	+S9	-S9	+S9
Distilled water	-	145	137	19	32
DMSO	-	151	141	23	28
4-Nitroquinoline 1-oxide	0.5	1588	148	167	36
Benzo[a]pyrene	2	4152	128	27	30
2-Acetylaminofluorene	5	178	928	35	614
N-Nitrosodimethylamine	50	128	1080	18	2292
Test chemical	10	121	111	18	31
	100	134	127	23	29
	200	157	13	33	34
	1000	148	141	22	33
	2000	115	136	24	33

 

Applicant's summary and conclusion

Conclusions:

The test chemical did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Executive summary:

Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical. The study was performed using Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system. The test chemical was dissolved in distilled water or DMSO as the solvent and used at dose level of 0, 10, 100, 200, 1000 or 2000 µg/plate. The exposure duration was 48 hrs at 37˚C. Concurrent solvent and negative control chemicals were also included in the study. The test chemical did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.