(Z)-3,7-dimethylocta-2,6-dienal

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test protocol comparable to OECD Guideline 471 with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1982

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2003

Reference 3

Reference Type:

publication

Title:

Salmonella Mutagenicity Tests: III . Results From the Testing of 255 Chemicals

Author:

Zeiger E, Anderson B, Haworth S, Lawlor T, Mortelmans K, Speck W

Year:

1987

Bibliographic source:

Environ. Mutagen. 9, Suppl. 9, 1-110

Reference 4

Reference Type:

other: abstract

Title:

TR-505 Toxicology and Carcinogenesis Studies of Citral (Microencapsulated) (CAS No. 5392-40-5) in F344/N Rats and B6C3F1 Mice (Feed Studies) - Draft Abstract

Author:

National Toxicology Program NTP

Year:

2003

Bibliographic source:

http://ntp-server.niehs .nih .gov/htdocs/LT-studies/tr505 .html

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

(four tested strains: TA1535, TA1537, TA98, TA100)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Citral

EC Number:

226-394-6

EC Name:

Citral

Cas Number:

5392-40-5

IUPAC Name:

3,7-dimethylocta-2,6-dienal

Constituent 2

Reference substance name:

(Z)-3,7-dimethylocta-2,6-dienal

EC Number:

203-379-2

EC Name:

(Z)-3,7-dimethylocta-2,6-dienal

Cas Number:

106-26-3

Molecular formula:

C10H16O

IUPAC Name:

(2Z)-3,7-dimethylocta-2,6-dienal

Details on test material:

- Name of test material (as cited in study report): Citral
- Analytical purity: 89% (data from Zeiger et al., 1987)

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

rat and hamster liver S9 (Aroclor induced)

Test concentrations with justification for top dose:

-S9: 1-67 µg/plate
+S9: 3.3-220 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: see remarks

Remarks:

without metabolic activation: TA98, 2-nitrofluorene; TA100 and TA1535, sodium azide; TA1537, 9-aminoacridine; with metabolic activation: all strains, 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 2 days

NUMBER OF REPLICATIONS: 3 per trial, 2 trials

DETERMINATION OF CYTOTOXICITY
- Method: decrease in number of his+ colonies or clearing in the density of background lawn

Evaluation criteria:

mutagenic response:
Individual trial: dose-related increase above solvent control
all trials combined: reproducible, dose-related increase over solvent control in replicate trials

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

without S9-mix: 67 µg/plate, with S9-mix: 160 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Mutagenicity of citral in Salmonella typhimurium

Strain TA 1535

Dose	No Activation (Trial 1)		No Activation (Trial 2)		10% HLI (Trial 1)		10% HLI (Trial 2)		10% RLI (Trial 1)		10% RLI (Trial 2)
µg/plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	29	4.5	25	2.6	17	2.6	9	1.7	14	1.5	7	1.9
1	25	1.9	18	3
3.3	27	3.8	23	1.7	14	2	11	1.2	17	0.6	12	0.9
10	27	3.8	23	4.1	13	2.9	12	3.8	8	0.3	9	2.1
33	26	3.8	23	4.3	16	2.3	12	0.3	13	1.5	13	3.8
50			16S	2
67	19S	2.3
100					18	3	14	2.7	11	1.2	8	0.6
160							11S	3.7			10S	1.3
220					T				T
Trial summary	Negative		Negative		Negative		Negative		Negative		Negative
Positive Control	1277	17.6	1098	39.7	119	5.2	57	2.8	99	6.2	71	5.3

Strain TA 100

Dose	No Activation (Trial 1)		No Activation (Trial 2)		10% HLI (Trial 1)		10% HLI (Trial 2)		10% RLI (Trial 1)		10% RLI (Trial 2)
µg/plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	155	3.2	154	6.1	148	9	146	5.8	122	7.9	150	8.4
1	152	16.8	146	9.4
3.3	136	7.2	141	2.4	157	4.8	149	2.2	111	11.3	128	3.5
10	140	6.9	143	7.1	145	9.7	134	8.4	126	2.8	122	1.7
33	134	3.8	147	14	145	0.9	142	5.2	123	8.1	138	2.1
50			132S	12.9
67	T
100					151	5.9	142	6.3	129	1	150	9.4
160							141S	1.9			126T	5.5
220					T				T
Trial summary	Negative		Negative		Negative		Negative		Negative		Negative
Positive Control	1386	11.9	1349	18.9	900	38.1	439	24.6	774	9.1	434	32.4

Strain TA 98

Dose	No Activation (Trial 1)		No Activation (Trial 2)		10% HLI (Trial 1)		10% HLI (Trial 2)		10% RLI (Trial 1)		10% RLI (Trial 2)
µg/plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	33	2.6	15	1.8	40	1.5	24	2	29	1.5	23	0.9
1	28	1	18	2.3
3.3	25	2.2	13	2.8	32	4.1	25	4.4	34	2.7	20	3.6
10	26	5.4	17	1.8	38	3.4	28	4.6	34	2.5	22	0.9
33	30	2.8	16	0.6	40	5.5	25	3.3	31	6.2	21	1.2
50			13	1.2
67	23S	0.9
100					30	1.5	29	4.1	34	3	21	1
160							21S	3.4			23S	1.5
220					T				T
Trial summary	Negative		Negative		Negative		Negative		Negative		Negative
Positive Control	1510	60.1	1171	55	890	39.3	288	6.8	679	19.5	328	20.3

Strain TA 1537

Dose	No Activation (Trial 1)		No Activation (Trial 2)		10% HLI (Trial 1)		10% HLI (Trial 2)		10% RLI (Trial 1)		10% RLI (Trial 2)
µg/plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	10	0.3	5	0.9	10	3.2	7	0.9	9	1.5	7	1
1	9	1.5	5	0.7
3.3	9	0.9	6	1.7	10	3.7	3	0.7	9	1.2	6	1
10	8	1.7	6	0.9	13	2.8	8	1	8	0.9	7	1.2
33	6	1.3	7	0.3	12	2	5	0.9	6	0.6	5	1
50			3S	1.2
67	T
100					9	0.6	6	1.5	9	0.7	7	1.9
160							5S	0.7			7S	0.6
220					T				T
Trial summary	Negative		Negative		Negative		Negative		Negative		Negative
Positive Control	547	36.5	516	58.9	74	1.2	30	0.3	54	3.2	34	6.4

Abbreviations:
RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and Precipitate; T = Toxic; c = Contamination