Reaction mass of 2-methyldecan-1-al and undecanal

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 from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From 23 APR 2010 to 13 JUL 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 471)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

according to Chemikaliengesetz (Chemicals act) of the Federar Republio of Germany (ChemG) §19a and §19b and annexes 1 and 2 in the version of 02 July 2008 published in Bundesgesetzblatt No. 28/2008, pp. 1146 - 1184

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Undecanal

EC Number:

203-972-6

EC Name:

Undecanal

Cas Number:

112-44-7

Molecular formula:

C11H22O

IUPAC Name:

undecanal

Details on test material:

- Name of test material (as cited in study report): n-undecanal
- Physical state: liquid, colourless
- Purity: 92.8 %
- Batch no: 50000018013
- Storage condition of test material: dark, at room temperature

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA97a, TA98, TA100, TA102, TA1535

Metabolic activation:

with and without

Metabolic activation system:

microsomal fraction (S9) produced from the livers of male Sprague-Dawley rats treated i.p. with 500 mg Aroclor 1254/kg body weight

Test concentrations with justification for top dose:

1st experiment: 4982, 1495, 498, 150, and 50 µg/plate (plate incorporation)
2nd experiment: 5036,2518, 1259, 630, and 315 µg/plate (pre-incubation method)

Vehicle / solvent:

- Solvent: Ethanol
- Justification for choice of solvent/vehicle: high tolerance for the tester strains, complete dissolution of the test substance

Controls

Untreated negative controls:

yes

Remarks:

(water)

Negative solvent / vehicle controls:

yes

Remarks:

(ethanol and DMSO)

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: see below "Details on test system"

Details on test system and experimental conditions:

METHOD OF APPLICATION:
1st experiment: plate incorporation
2nd experiment: preincubation

DURATION
- Preincubation period: 20 min, 37 °C
- Exposure duration: 48 h, 37 °C

NUMBER OF REPLICATIONS: 4

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth ==> inhibition of growth of the background lawn

POSITIVE CONTROLS
sodium azide (1 µg/plate; TA 100 and TA 1535 without metabolic activation)
4-nitro-o-phenylenediamine (20 µg per plate; TA 97a, TA 98 and TA 102 without metabolic activation)
2-aminoanthracene (1 µg/plate; TA 97a, TA 100, TA 102 and TA 1535 with metabolic activation)
benzo(a)pyrene (20 µg/plate; TA 98 with metabolic activation)

Evaluation criteria:

A test item is considered to have mutagenic potential, if a significant, reproducible increase of in the number of revertant colonies per plate (increase factor (f(I)) >= 2) in at least one strain can be observed. A concentration-related increase can also be taken as a sign of mutagenic activity.

Statistics:

calculation of mean values with standard deviations

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA97a, TA98, TA100, TA102, TA1535

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

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

COMPARISON WITH HISTORICAL CONTROL DATA:
In general, the determined values for the spontaneous reversion rates as well as the positive controls were within the normal range of the laboratory.
In isolated cases of outliers, the differences to the respective maximum or minimum of the history were marginal only.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Mean revertant values of first experiment (plate incorporation assay)

Strain		TA97a		TA98		TA100		TA102		TA1535
Induction		-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
H20	Mean	121	115	10	20	119	101	178	155	10	9
	sd	9.0	1,7	1.9	3.7	7.7	23.5	15.5	13.6	3.4	1.5
DMSO	Mean	125	128	7	12	118	118	154	164	11	10
	sd	10.5	12.7	1.7	5.9	11.4	22.9	35.7	14.3	4.3	4.8
Ethanol	Mean	142	130	8	14	107	115	204	130	9	10
	sd	223	9.0	2.4	3.9	15.0	10.1	60.3	9.7	3.0	1.5
Pos.Contr.	Mean	652	878	1000	849	717	567	687	599	533	573
	sd	• 138	122	231	79	53	112	95	125	64	22
	f(l)	5,22	6.86	142.9	7075	6,03	4.81	4.46	3.65	53.30	57.30
4982 µg/pl.	Mean	116	121	11	9	108	108	169	154	11	9
	sd	6	4	2	1	17	14	10	31	4	1
	f(l)	0.82	0.93	1.38	0.64	1.01	0.94	0.83	1.18	112	0.90 12 2
1495 µg/pl.	Mean	121	122	7	10	120	122	154	169	12
	sd	15	8	3	1	22	17	22	12	2
	f(l)	0.85	0.94	0.88	0.71	1.12	1.06	0.75	1.30	1.33	1.20
498 µg/pl.	Mean	112	109	'11	10	111	102	124	129	9	12
	sd	9	12	1	4	5	16 0.89	9	17 0.99	3	2
	f(l)	0.79	0.84	1.38	0.71	1.04		0.61		1.00	1.20
150 µg/pl.	Mean	120	113	11	8	116	114	148	156	10	11
	sd	12	8	5	3	4	6 0.99	29	22	0	2
	f(l)	0.85 125	0.87	1,38	0.57	1.08		0.73	1.20	1.11	1.10
50 µg/pl.	Mean		113	9	13	116	117	152	147	12	13
	sd	15	6	3	2	11	4	25	39	5	4
	f(l)	0.88	0.87	1.13	0,93	1.08	1.02	0.75	1.13	1.33	1.30

f(I)= increase factor, see ecaluation criteria

Mean revertant values of second experiment (pre-incubation assay)

Strain		TA97a		TA98		TA100		TA102		TA1535
Induction		-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
H2O	Mean	109	121	9	7	135	93	204	212	10	16
	sd	6.3	11.0	1.4	0.5	3.9	19.1	27.0	42.6	1.9	1.3
DMS0	Mean	110	120	10	10	126	88	137	145	12	14
	sd	4.5	1.7	0.6	0.0	6.8	14.8	12.1	21.9	2.9	1.8
Ethanol	Mean	118	108	9	7	84	127	128	225	15	14
	sd	7.3	6.3	1.4	1.5	13.6	4.9	9.7	31.4	5.6	1.3
Pos.Contr.	Mean	504	824	218	185	465	727	401	717	291	584
	sd	81	178	16	49	41	231	33	82	94	148
	f(l)	4.58	6.87	21.80	18.50	3.44	8.26	2.93	4.94	29.10	41.71
5036µg/pl.	Mean	116	97	10	10	114	112	215	212	12	11
	sd f(l)	5	4 0.90	1	0	2	3	14	15	2	1
		0.98		1.11	1.43	1.36	0.88	1.68	0.94	0.80	0.79
2518µg/pl..	Mean	108	105	9	10	120	112	192	115	11	11
	sd	7	5	1	2	6	2	39	5	1	1
	f(l)	0.92	0.97	1.00	1.43 11	1.43 10	0.88	1.50	0.51	0.73	0.79
1259µg/pl.	Mean	114	113	11			11	138	137	13	16
	sd	11	13	2	3	1	3	14	17	2	1
	f(l)	0.97	1.05	1.22	1.57	0.12	0.09	1.08	0.61	0.87	1.14
630µg/pl.	Mean	110	108	8	8	117	127	135	151	10	13
	sd	11	7	2	2	10	5	19	17	1	3
	f(l)	0.93	1.00	0.89	1.14	1.39	1.00	1.05	0.67	0.67	0.93
315µg/pl.	Mean	117	109	10	10	130	104	130	145	13	12
	sd	15	4	1	0	16	3	27	14	2	1
	f(l)	0.99	1.01	1.11	1.43	1.55	0.82	1.02	0.64	0.87	0_86

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

N-undecanal was not mutagenic under the conditions of this study.

Executive summary:

N-undecanal (purity: 92.8%) was examined in the Ames-test according to OECD TG 471 under GLP conditions using the Salmonella typhimurium strains TA97a, TA98, TA100, TA102, and TA1535 both in the absence and presence of metabolic activation (S9 from male Aroclor 254 induced rat liver). The test substance concentrations in the first experiment were 4982, 1495, 498, 150, and 50 µg/plate (plate incorporation). To verify the results a second experiment was performed with the pre-incubation method using concentrations of 5036, 2518, 1259, 630, and 315 µg/plate.

Testing up to the limit dose required no cytotoxicity was observed with n-undecanal.

In both tests, the vehicle controls (DMSO, ethanol), the negative (water) and the positive controls performed as expected, while n-undecanal did not increase the number of revertants in any strain at any dose, with or without metabolic activation. Thus, n-undecanal was not mutagenic.

This study is classified as reliable without restrictions. It was performed in accordance with OECD test guideline 471 and GLP (LAUS, 2010).

The negative result can be transferred to the registered n-/iso-undecanal. Refer to the discussion field of the endpoint summary for detailed justification of read across.