Fatty acid chlorides, C8-14 (even numbered), reaction products with glycine

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)

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:

Sodium cocoyl glycinate (SCG) [INCI]

IUPAC Name:

Sodium cocoyl glycinate (SCG) [INCI]

Details on test material:

- Physical state: Liquid
- Stability under test conditions: Stable in water for days at room temperature (not quantified)
- Storage condition of test material: At room temperature

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

induced rat liver S9-mix

Test concentrations with justification for top dose:

3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / pre-experiment/experiment I and experiment II

Vehicle / solvent:

Deionised water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

other: sodium azide; 4-nitro-o-phenylene-diamine; methyl methane sulfonate, 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar plate incorporation; preincubation


DURATION
- Preincubation period: 1 hour
- Exposure duration: 72 hours


NUMBER OF REPLICATIONS: 3 plates

Evaluation criteria:

A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed .
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration .
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.

Statistics:

According to the OECD guideline 471, a statistical analysis of the data is not mandatory.

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:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative 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:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative 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:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative 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:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative 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:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS

Any other information on results incl. tables

Summary Tabellen

    Summary of Results Pre-Experiment and Experiment I

Study Name: 1211000	Study Code: Harlan CCR 1211000
Experiment: 1211000 VV Plate	Date Plated: 17/09/2008
Assay Conditions:	Date Counted: 24/09/2008

Metabolic Activation	Test Group	Dose Level (µg/plate)		Revertant Colony Counts (Mean ±SD)
				TA 1535	TA 1537	TA 98	TA 100	WP2 uvrA
Without Activation	Deionised water			20 ± 3	11 ± 3	35 ± 2	137 ± 5	55 ± 4
	Untreated			18 ± 3	13 ± 3	37 ± 10	126 ± 4	47 ± 3
	Hostapon SG	3 µg		20 ± 3	11 ± 4	29 ± 1	134 ± 12	50 ± 4
		10 µg		19 ± 4	14 ± 2	33 ± 5	124 ± 8	52 ± 6
		33 µg		18 ± 3	11 ± 4	35 ± 6	132 ± 10	55 ± 1
		100 µg		19 ± 4	8 ± 0	37 ± 6	139 ± 16	52 ± 4
		333 µg		13 ± 2	10 ± 4	32 ± 8	122 ± 15	63 ± 3
		1000 µg		17 ± 2	7 ± 1	25 ± 5	84 ± 11^R	62 ± 2
		2500 µg		8 ± 2^M R	2 ± 2^M R	19 ± 2^M R	36 ± 5^M R	59 ± 2
		5000 µg		2 ± 2^M R	0 ± 1^M R	5 ± 2^M R	27 ± 3^M R	58 ± 2
	NaN3	10 µg		2009 ± 31			2369 ± 114
	4-NOPD	10 µg				424 ± 9
	4-NOPD	50 µg			83 ± 3
	MMS	3.0 µL						1017 ± 33
With Activation	Deionised water			23 ± 3	20 ± 5	37 ± 4	148 ± 5	68 ± 4
	Untreated			24 ± 6	19 ± 7	42 ± 8	148 ± 14	64 ± 9
	Hostapon SG	3 µg		24 ± 3	19 ± 5	39 ± 5	129 ± 14	64 ± 4
		10 µg		21 ± 5	17 ± 5	44 ± 8	135 ± 3	71 ± 2
		33 µg		25 ± 3	19 ± 3	43 ± 6	132 ± 9	60 ± 11
		100 µg		23 ± 1	15 ± 2	38 ± 4	134 ± 5	60 ± 4
		333 µg		22 ± 5	13 ± 2	47 ± 6	136 ± 13	73 ± 11
		1000 µg		15 ± 4	16 ± 3	35 ± 3	116 ± 13	69 ± 3
		2500 µg		9 ± 3^M R	8 ± 1^M R	28 ± 2^M R	48 ± 7^M R	66 ± 1
		5000 µg		5 ± 1^M R	1 ± 1^M R	13 ± 2^M R	34 ± 5^M R	59 ± 4
	2-AA	2.5 µg		245 ± 16	191 ± 30	1267 ± 70	1506 ± 43
	2-AA	10.0 µg						232 ± 24

Key to Positive Controls		Key to Plate Postfix Codes
NaN3 2-AA 4-NOPD MMS	sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate	R M	Reduced background growth Manual count

     Summary of Results Experiment II

Study Name: 1211000	Study Code: Harlan CCR 1211000
Experiment: 1211000 HV2 Pre	Date Plated: 01/10/2008 / 14/10/2008*
Assay Conditions:	Date Counted: 08/10/2008 / 17/10/2008*

Metabolic Activation	Test Group	Dose Level (µg/plate)		Revertant Colony Counts (Mean ±SD)
				TA 1535	TA 1537	TA 98*	TA 100	WP2 uvrA
Without Activation	Deionised water			19 ± 6	12 ± 4	22 ± 2	131 ± 5	51 ± 8
	Untreated			16 ± 6	10 ± 2	24 ± 4	137 ± 12	46 ± 8
	Hostapon SG	3 µg		17 ± 4	14 ± 5	23 ± 2	131 ± 8	55 ± 1
		10 µg		18 ± 4	15 ± 2	24 ± 2	127 ± 9	52 ± 8
		33 µg		18 ± 3	11 ± 6	24 ± 4	122 ± 1	55 ± 6
		100 µg		22 ± 6	14 ± 3	23 ± 1	101 ± 15^R	56 ± 2
		333 µg		12 ± 5	10 ± 4	15 ± 2	75 ± 7^R	47 ± 4
		1000 µg		5 ± 2^R M	2 ± 3^M R	10 ± 1^M R	39 ± 5^M R	49 ± 5
		2500 µg		2 ± 2^M R	0 ± 0^M R	3 ± 2^M R	31 ± 10^M R	46 ± 5
		5000 µg		1 ± 1^M R	0 ± 0^M R	0 ± 0^M R	5 ± 2^M R	37 ± 7
	NaN3	10 µg		1799 ± 67			1998 ± 31
	4-NOPD	10 µg				1637 ± 116
	4-NOPD	50 µg			105 ± 5
	MMS	3.0 µL						418 ± 20
With Activation	Deionised water			17 ± 4	16 ± 5	26 ± 3	138 ± 9	58 ± 5
	Untreated			18 ± 4	19 ± 7	29 ± 3	142 ± 37	64 ± 7
	Hostapon SG	3 µg		19 ± 4	17 ± 4	27 ± 0	131 ± 11	59 ± 3
		10 µg		22 ± 4	17 ± 4	25 ± 2	132 ± 8	58 ± 3
		33 µg		20 ± 2	19 ± 3	24 ± 2	141 ± 15	59 ± 6
		100 µg		21 ± 1	15 ± 3	22 ± 5	140 ± 7	57 ± 5
		333 µg		18 ± 4	14 ± 4	19 ± 3	110 ± 5^R	53 ± 2
		1000 µg		11 ± 3^M R	12 ± 2^M R	10 ± 2^M R	74 ± 7^R	54 ± 1
		2500 µg		9 ± 3^M R	8 ± 2^M R	4 ± 3^M R	31 ± 2^M R	59 ± 4
		5000 µg		0 ± 0^M R	0 ± 0^M R	0 ± 0^M R	31 ± 4^M R	61 ± 3
	2-AA	2.5 µg		256 ± 8	105 ± 10	1616 ± 151	1346 ± 157
	2-AA	10.0 µg						334 ± 24

Key to Positive Controls		Key to Plate Postfix Codes
NaN3 2-AA 4-NOPD MMS	sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate	R M	Reduced background growth Manual count

* Repeated experiment

Applicant's summary and conclusion

Conclusions:

The registration substance Hostapon SG is not mutagenic in Ames test.

Executive summary:

The registration substance Hostapon SG was investigated for its mutagenicity in bacterial mutation reverse assay according to the Guideline OECD 471. Up to the concentration of 5000 µg/plate no mutagenic property was found without and with metabolic activation in strains TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA in two indepedant experiments. Hostapon SG is not mutagenic in Ames test.