Diallylamine

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

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

Author:

Zeiger et al

Year:

1987

Bibliographic source:

Environmental Mutagenesis Volume 9, Supplement 9:1-110

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Diallylamine

EC Number:

204-671-2

EC Name:

Diallylamine

Cas Number:

124-02-7

Molecular formula:

C6H11N

IUPAC Name:

diallylamine

Specific details on test material used for the study:

Purity: 98%

Method

Target gene:

histidine gene (for S. typhimurium)

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:

liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters

Test concentrations with justification for top dose:

0, 33, 100, 333, 1000, 3333 and 10,000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ET95, ETOH; 95% ethanol (solvent)

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

ET95

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 4-nitro-o-phenylenediamine; 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: Tripicate (for each dose)

DETERMINATION OF CYTOTOXICITY
- Method: Number of his+ colonies and clearing in the density of background lawn.

Evaluation criteria:

An individual trial was judged mutagenic (+) if a dose-related increase over the corresponding solvent control was seen, and it was judged weakly mutagenic (+W) if a low-level dose response was seen. A trial was considered questionable (?) if a dose-related increase was judged insufficiently high to justify a call of "+W" if only a single dose was elevated over the control, or if a non-dose related increase was seen.

A chemical was judged to be mutagenic (+), or weakly mutagenic (+W), if it produced a reproducible, dose-related increase in his+ revertants over the corresponding solvent controls in replicate trials. A chemical was considered to be questionable (?) if a reproducible increase of his+ revertants did not meet the criteria for either a "+" or "+W", or if only single doses produced an increase in his+ revertants in repeat trials.

Results and discussion

Test results

Species / strain:

other: 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:

complete clearing of background lawn seen at 10000 µg/plate (TA100 and TA98) and at 3333 µg/plate (TA1537) without metabolic activation

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Any other information on results incl. tables

A summary of results obtained for diallylamine are presented below:

Mutagenic responses of Salmonella tester strains (mean ± SEM; three plate) to Diallylamine. The 0 µg/plate dose is the solvent control.

Abbreviations:

ET95, ETOH; 95% ethanol (solvent)

POS: Positive control

NA: Not acivated

RLI: Aroclor 1254 -induced rat liver S-9.

HLI: Aroclor 1254 -induced hamster liver S-9

t: complete clearing of background lawn (colonies not counted)

(-): non-mutagenic

Diallyamine

Solvent: ET95

Dose	TA100						TA1535						TA1537						TA98
µg/plate	NA (-)		10% HLI (-)		10% RLI       (-)		NA (-)		10% HLI (-)		10% RLI       (-)		NA (-)		10% HLI (-)		10% RLI       (-)		NA (-)		10% HLI (-)		10% RLI          (-)
	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM	Mean	SEM
0	86	5.1	146	5.3	115	12.5	5	1.2	10	1.3	7	0.6	7	0.7	9	0.9	6	0.7	14	4.5	26	1.8	25	1.5
33							5	2.7					7	2.3			5	0.6
100	88	4.7	139	3.4	136	9.8	5	1.8	16	0.6	8	0.6	6	0.3	10	1.2	5	1.2	17	1.9	19	1.5	18	3.2
333	94	2.5	138	9.5	130	9.2	5	0.7	10	0.9	5	0.9	5	1.5	8	0.7	7	0.6	18	0.9	22	1.7	21	1.5
1000	88	2.4	145	16.0	145	3.8	2	1.9	7	2.4	6	1.0	6	1.5	8	0.9	5	2.3	20	2.0	21	4.5	18	1.2
3333	87	3.2	135	5.8	143	12.4	2	1.2	7	1.8	6	1.2	t		5	0.9	2	0.6	7	3.1	15	4.1	17	2.6
10000	t		132	5.2	120	11.8	2	0.5	3	0.5	2	0.7			1	0.3			t		6	1.5	5	1.2
POS	441	41.9	1955	23.9	1186	54.6	532	19.8	359	64.3	344	29.9	199	57.9	162	5.2	268	30.4	197	9.3	1421	69.0	741	125.3

Applicant's summary and conclusion

Conclusions:

Diallylamine was considered to be non-mutagenic under the conditions of this test.

Executive summary:

Diallylamine was tested using a preincubation modification of the Salmonella/microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor induced male Sprague-Dawley rats and Syrian hamsters.

The tested Salmonella typhimurium strains were TA98, TA100, TA1535 and TA1537.

The test conceentrations of Diallylamine were 33, 100, 333, 1000, 3333 and 10,000 µg/plate, with concurrent solvent and positive controls.

Diallylamine was considered to be non-mutagenic under the conditions of this test. No reproducible, dose-related increase in his+ revertants over the corresponding solvent controls in replicate trials was observed.

The positive control chemicals used in thetest induced marked increases in the frequency of revertant colonies, both with and without metabolic activiation.

Complete clearing of background lawn was seen at 10000 µg/plate (TA100 and TA98) and at 3333 µg/plate (TA1537) without metabolic activation