Sunflower oil, ester with sorbitol

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:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sunflower oil, ester with sorbitol

EC Number:

306-248-9

EC Name:

Sunflower oil, ester with sorbitol

Cas Number:

96690-53-8

IUPAC Name:

sunflower seed oil sorbitol esters

Test material form:

liquid

Details on test material:

Batch Number: P08/002
Expiry Date: 2010-03-01
Stability of Polyethyleneglycol: stable for hours

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

Phenobarbital/ß-Naphtholflavone induced rat liver S9

Test concentrations with justification for top dose:

In preliminary cytoxicity test, no significant cytotoxicity was found. Therefore the main studies (Exp I and Exp II) were performed up to the dose of 5000 µg/plate.

Vehicle / solvent:

DMSO was used

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: see the additional information

Results and discussion

Test results

Test results 1

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

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

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

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

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

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

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

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Table: Summary of Results_Experiment I
Metabolic Activation	Test Group	Dose Level (µg/plate)	Revertant Colony Counts (Mean ±SD)
			TA 1535	TA 1537	TA 98	TA 100	WP2 uvrA
Without metabolic Activation	DMSO		22 ± 2B M	14 ± 2	27 ± 4	114 ± 15	45 ± 6
	Untreated		23 ± 5B M	10 ± 3	36 ± 3	115 ± 13	47 ± 1
	Hostacerin SFO	3µg	24 ± 1B M S	14 ± 5	32 ± 9	114 ± 14	44 ± 5
		10µg	21 ± 4B M	11 ± 2	31 ± 3	112 ± 7	47 ± 9
		33µg	20 ± 4B M	12 ± 4	34 ± 6	112 ± 7	43 ± 7
		100µg	20 ± 5B M	8 ± 2	33 ± 7	113 ± 7	45 ± 7
		333µg	22 ± 4B M	11 ± 2	35 ± 7	110 ± 8	41 ± 4
		1000µg	18 ± 3P B M	9 ± 2P	32 ± 3P	108 ± 7P	38 ± 3P
		2500µg	17 ± 5P B M	11 ± 3P	30 ± 0P	109 ± 10P	50 ± 2P
		5000µg	14 ± 2P B M	12 ± 3P	25 ± 1P M	113 ± 7P	38 ± 6P M
	NaN3	10 µg	3126 ± 67			2708 ± 167
	4-NOPD	10 µg			516 ± 22
	4-NOPD	50 µg		99 ± 6
	MMS	3.0 µg					917 ± 65
With metabolic activation	DMSO		26 ± 3B M	25 ± 5	47 ± 3	104 ± 7	66 ± 12
	Untreated		28 ± 3B M	27 ± 1	43 ± 4	118 ± 10	50 ± 9
	Hostacerin SFO	3µg	23 ± 4B M	21 ± 4	44 ± 7	111 ± 5	61 ± 10
		10µg	23 ± 4B M	26 ± 1	41 ± 6	114 ± 4	61 ± 8
		33µg	24 ± 3B M	22 ± 5	41 ± 4	110 ± 5	60 ± 5
		100µg	21 ± 3B M	19 ± 2	46 ± 5	110 ± 15	50 ± 14
		333µg	23 ± 4B M	20 ± 0	44 ± 1	112 ± 4	53 ± 2
		1000µg	17 ± 1P B M	21 ± 8P	45 ± 6P	99 ± 1P	52 ± 4P
		2500µg	19 ± 1P B M	21 ± 7P	43 ± 13P	101 ± 1P	56 ± 2P
		5000µg	19 ± 3P B M	18 ± 3P	30 ± 4P M	94 ± 5P M	45 ± 1P M
	2-AA	2.5 µg	224 ± 14	150 ± 14	1633 ± 69	1096 ± 96
	2-AA	10.0 µg					359 ± 15

NaN3: sodium azide

2-AA: 2-aminoanthracene

4-NOPD: 4-nitro-o-phenylene-diamine

MMS: methyl methane sulfonate

P: Precipitate

MB: Manual count

B: Extensive bacterial growth

Table: Summary of Results_Experiment II
Metabolic Activation	Test Group	Dose Level (µg/plate)	Revertant Colony Counts (Mean ±SD)
			TA 1535	TA 1537	TA 98	TA 100	WP2 uvrA
Without metabolic Activation	DMSO		39 ± 2	13 ± 4	28 ± 6	130 ± 15	47 ± 16
	Untreated		39 ± 1	20 ± 2	25 ± 2	153 ± 12	47 ± 4
	Hostacerin SFO	33µg	38 ± 5	10 ± 1	29 ± 8	123 ± 10	48 ± 4
		100µg	32 ± 2	12 ± 1	24 ± 4	122 ± 14	48 ± 9
		333µg	38 ± 2	11 ± 3	26 ± 8	129 ± 10	56 ± 5
		1000µg	31 ± 4P	12 ± 6P	23 ± 1P	108 ± 10P R	52 ± 6P
		2500µg	25 ± 7P	7 ± 1P R	25 ± 7P	91 ± 14P R	43 ± 3P
		5000µg	15 ± 2M R P	7 ± 2P M R	7 ± 1P M R	76 ± 6P M R	31 ± 7P M R
	NaN3	10 µg	2642 ± 177			2794 ± 49
	4-NOPD	10 µg			615 ± 42
	4-NOPD	50 µg		140 ± 6
	MMS	3.0 µg					355 ± 143
With metabolic activation	DMSO		33 ± 6	18 ± 6	43 ± 5	134 ± 15	56 ± 8
	Untreated		33 ± 7	20 ± 5	43 ± 8	157 ± 10	47 ± 9
	Hostacerin SFO	33µg	35 ± 11	17 ± 4	40 ± 8	139 ± 15	59 ± 5
		100µg	34 ± 11	18 ± 9	44 ± 8	136 ± 3	62 ± 6
		333µg	30 ± 7	20 ± 8	40 ± 8	133 ± 10	51 ± 10
		1000µg	35 ± 1P	18 ± 4P	43 ± 8P	130 ± 21P	64 ± 6P
		2500µg	20 ± 4P R	11 ± 2P M R	38 ± 8P	95 ± 2P R	48 ± 6P M
		5000µg	19 ± 3P M R	5 ± 3P M R	14 ± 3P M R	40 ± 2P M R	40 ± 8P M R
	2-AA	2.5 µg	276 ± 8	209 ± 5	1872 ± 143	2337 ± 376
	2-AA	10.0 µg					243 ± 1

NaN3: sodium azide

2-AA: 2-aminoanthracene

4-NOPD: 4-nitro-o-phenylene-diamine

MMS: methyl methane sulfonate

P: Precipitate

R: Reduced background count

MB: Manual count

Applicant's summary and conclusion

Conclusions:

The genotoxicity of the registration substance was investigated in bacterial reverse muation test (Ames test) according to the Guideline OECD 471. No mutagenicity was found.

Executive summary:

The genotoxicity of the registration substance was investigated in bacterial reverse muation test (Ames test) according to the Guideline OECD 471. using TA 1535, TA 1537, TA 98, TA 100 and WP2 uvrA as test systems. At concentrations 1000 µg/plate and above precipitation occured. Up to the highest concentration of 5000 µg/plate no cytoxicity and no mutagenicity was found.