4-dimethylaminobenzaldehyde

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

For this endpoint information from a GLP compliant OECD 471 assay is available. The test material was negative in this study.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 18 - 29, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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

Specific details on test material used for the study:

Name: Art. 803057
Chemical name: 4-dimethylaminobenzaldehyde
CAS: 100-10-7
Appearance: grey-blue, crystalline
Released until: 31 May 2019
Solvent for test material: DMCO
Concentration of solvent: 10 µL/plate

Target gene:

Salmonella: histidine operon
E coli. tryptophane operon

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

- Type and identity of media:
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes

Metabolic activation:

with and without

Metabolic activation system:

S9 mix from Aroclor 1254 pretreated rats

Test concentrations with justification for top dose:

1st series: 5, 15.8, 50, 158, 500, 1580, 5000 µg/plate
2nd series:15.8, 50, 158, 500, 1580, 2810 µg/plate

Vehicle / solvent:

DMSO

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: Sodium azide, 2-Aminoanthracene, 9-Aminoacridine, Daunomycin, 4-Nitroquinoline-N-oxide

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: 3-5 hours
- Exposure duration: about 2 days


SELECTION AGENT (mutation assays): Histidine, Tryptophane

NUMBER OF REPLICATIONS:
Negative controls 6
Test material 3
Positive controls 3


NUMBER OF CELLS EVALUATED: about 1e9


DETERMINATION OF CYTOTOXICITY
- Method: other: background cytotox


OTHER:

Evaluation criteria:

- valid assay (cf. laboratory historical data)
- no or weak increase in revertant colonies = negative
- clear, dose dependent (over at least two concentrations), and reproducible increase in revertant colonies= positve

Statistics:

not applied

Key result

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no
- Effects of osmolality: no
- Evaporation from medium: no
- Water solubility: ok
- Precipitation: yes, at 1580 µg/plate with and without metabolic activation
- Other confounding effects: no

Study Name: 15-DA187-N0 1. Serie	Study Code:
Experiment: Art.803057	Date Plated: 23/06/2015
Assay Conditions:	Date Counted: 26/06/2015

 

Metabolic Activation	Test Material	Concentr. [µg/plate]		Revertants per plate (Mean ± SD)
				TA 98	TA 100	TA 1535	TA 1537	WP2 uvrA
Without Activation	DMSO			49 ± 5	126 ± 8	42 ± 5	28 ± 6	40 ± 10
	Art.803057	5.00		47 ± 9	110 ± 22	29 ± 3	23 ± 3	25 ± 2
		15.8		40 ± 4	115 ± 5	28 ± 1	27 ± 4	36 ± 7
		50.0		36 ± 1	130 ± 11	35 ± 5	23 ± 3	30 ± 6
		158		36 ± 3	121 ± 12	47 ± 22	24 ± 8	35 ± 6
		500		43 ± 4	105 ± 15	39 ± 4	30 ± 3	27 ± 2
		1580		44 ± 8^B	99 ± 4^B	52 ± 6^B	32 ± 4^B	23 ± 4^B
		5000		42 ± 3^B T	68 ± 1^B T	58 ± 5^B	34 ± 3^B	15 ± 2^B T
	DAUN	1.00		89 ± 10
	NaN3	2.00			1082 ± 55	705 ± 18
	9-AA	50.0					401 ± 211
	NQO	2.00						1275 ± 83
With Activation	DMSO			43 ± 5	124 ± 16	28 ± 5	29 ± 5	48 ± 9
	Art.803057	5.00		41 ± 7	116 ± 23	31 ± 10	23 ± 7	41 ± 9
		15.8		39 ± 4	128 ± 2	26 ± 4	23 ± 8	40 ± 3
		50.0		45 ± 7	135 ± 5	18 ± 5	31 ± 4	52 ± 13
		158		44 ± 6	135 ± 7	26 ± 6	27 ± 4	42 ± 13
		500		51 ± 3	115 ± 14	21 ± 9	27 ± 4	39 ± 7
		1580		49 ± 7^B	101 ± 11^B	25 ± 5^B	30 ± 4^B	24 ± 8^B
		5000		46 ± 8^B T	75 ± 12^B T	25 ± 5^B	28 ± 9^B	10 ± 5^B
	2-AA	2.00		697 ± 27	1429 ± 27
	2-AA	5.00				320 ± 22	367 ± 43
	2-AA	10.0						420 ± 78

 

Key to Positive Controls		Key to Plate Postfix Codes
NaN3 2-AA 9-AA DAUN NQO	Sodium azide 2-Aminoanthracene 9-Aminoacridine Daunomycin 4-Nitroquinoline-N-oxide	B T	Precipitation at beginning of experiment Toxicity = red. bact. background lawn

 

 

Study Name: 15-DA187-N0 2. Serie	Study Code:
Experiment: Art.803057	Date Plated: 07/07/2015
Assay Conditions:	Date Counted: 09/07/2015

 

Metabolic Activation	Test Material	Concentr. [µg/plate]		Revertants per plate (Mean ± SD)
				TA 98	TA 100	TA 1535	TA 1537	WP2 uvrA
Without Activation	DMSO			36 ± 9	116 ± 8	33 ± 6	25 ± 5	31 ± 2
	Art.803057	15.8		40 ± 8	97 ± 21	29 ± 2	20 ± 10	35 ± 1
		50.0		35 ± 6	116 ± 14	39 ± 6	22 ± 1	36 ± 8
		158		43 ± 4	113 ± 11	39 ± 5	24 ± 3	30 ± 2
		500		33 ± 3	105 ± 15	40 ± 2	18 ± 2	27 ± 7
		1580		45 ± 2^B	94 ± 5^B	47 ± 6^B	29 ± 9^B	26 ± 4^B
		2810		44 ± 2^B	66 ± 6^B	49 ± 6^B	21 ± 8^B	16 ± 5^B
	DAUN	1.00		293 ± 36
	NaN3	2.00			1576 ± 51	931 ± 50
	9-AA	50.0					2313 ± 737
	NQO	2.00						1978 ± 73
With Activation	DMSO			44 ± 4	130 ± 10	31 ± 4	24 ± 3	45 ± 8
	Art.803057	15.8		59 ± 13	129 ± 9	35 ± 4	28 ± 10	40 ± 4
		50.0		52 ± 7	119 ± 3	36 ± 1	24 ± 4	43 ± 7
		158		38 ± 7	129 ± 16	31 ± 3	33 ± 2	46 ± 3
		500		46 ± 6	116 ± 19	26 ± 8	23 ± 4	46 ± 6
		1580		53 ± 10^B	87 ± 12^B	19 ± 5^B	20 ± 2^B	34 ± 9^B
		2810		52 ± 6^B	69 ± 10^B	15 ± 2^B	21 ± 1^B	17 ± 4^B
	2-AA	2.00		292 ± 17
	2-AA	5.00			1683 ± 158
	2-AA	10.0				242 ± 22	121 ± 23	215 ± 8

 

Key to Positive Controls		Key to Plate Postfix Codes
NaN3 2-AA 9-AA DAUN NQO	Sodium azide 2-Aminoanthracene 9-Aminoacridine Daunomycin 4-Nitroquinoline-N-oxide	B	Precipitation at beginning of experiment

 

Conclusions:

With and without addition of S9 mix as the external metabolizing system, the test material was not mutagenic under the experimental conditions described.

Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 471. With and without addition of S9 mix as the external metabolizing system, the test material was not mutagenic under the experimental conditions described.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available information a classification for this endpoint is not justified.