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REACH

1,3-Propanediamine, N-[3-((C11-14, C13-rich)oxy)propyl]- branched acetate

EC number: 931-295-2 | CAS number: -

Life Cycle description
Uses advised against

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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
Study period:: 2009 -10-20 till 2009-11-19
Reliability:: 1 (reliable without restriction)
Rationale for reliability incl. deficiencies:: guideline study

Data source

Reference

Reference Type:: study report
Title:: Unnamed
Year:: 2009
Report date:: 2009

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

Test material form:: liquid
Details on test material:: Chemical name: 1,3-Propanediamine, N-[3-((C11-14, C13-rich)oxy)propyl]- branched acetate
EC no.: 931-295-2

To the best of knowledge, the sample used is representative to the boundary composition.

Specific details on test material used for the study:: Etherdiamine C13i/acetate: Standard Commercial grade

Method

Species / strain

Species / strain / cell type:: other: TA 1535, TA 1537, TA 98, TA 100, TA 102
Additional strain / cell type characteristics:: not applicable

Metabolic activation:: with and without
Metabolic activation system:: Phenobarbital/ß-Naphthoflavone induced rat liver S9
Test concentrations with justification for top dose:: Pre-Experiment: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment I
without S9 mix: 0.01; 0.03; 0.1; 0.3; 1; 3; 10; 33; and 100 µg/plate
with S9 mix: 0.03; 0.1; 0.3; 1; 3; 10; 33; 100; and 333 µg/plate
Experiment II
without S9 mix: 0.01; 0,03; 0.1; 0.3; 1; 3; 10; and 33 µg/plate
with S9 mix: 0.03; 0.1; 0.3; 1; 3; 10; 33; and 100 µg/plate
Vehicle / solvent:: - Vehicle(s)/solvent(s) used: deionised water
- Justification for choice of solvent/vehicle: better than others

Controls

Untreated negative controls:: yes
Negative solvent / vehicle controls:: yes
True negative controls:: no
Positive controls:: yes
Positive control substance:: 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 and preincubation

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

NUMBER OF REPLICATIONS: 3 plates

DETERMINATION OF CYTOTOXICITY
A reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn.
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, andTA 102) 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 resultsopen all close all

Test results 1

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

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

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

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

Species / strain:: S. typhimurium TA 102
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
- Water solubility:
- Precipitation:
The test item precipitated in the overlay agar in the test tubes from 1000 µg/plate up to 5000 µg/plate in the pre-experiment and at 333 µg/plate in experiment I. Precipitation of the test item on the incubated agar plates was observed from 333 µg/plate up to 5000 µg/plate in the pre-experiment and at 333 µg/plate in experiment I. The undissolved particles of the test item had no influence on the data recording.
- Other confounding effects:
COMPARISON WITH HISTORICAL CONTROL DATA: performed
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The plates incubated with the test item showed reduced background growth at the following concentrations (µg/plate):
Strain Pre-Experiment Experiment I Experiment II
without S9 mix with S9 mix without S9 mix with S9 mix without S9 mix with S9 mix
TA 1535 10 - 5000 100 - 5000 10 - 100 100 - 333 3 - 33 33 - 100
TA 1537 10 - 5000 100 - 5000 10 - 100 33 - 333 3 - 33 33 - 100
TA 98 10 - 5000 33 - 5000 10 - 100 33 - 333 3 - 33 33 - 100
TA 100 10 - 5000 100 - 5000 10 - 100 100 - 333 3 - 33 33 - 100
TA 102 3 - 5000 33 - 5000 1 - 100 10 - 333 3 - 33 33 - 100
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain Pre-Experiment Experiment I Experiment II
without S9 mix with S9 mix without S9 mix with S9 mix without S9 mix with S9 mix
TA 1535 33 - 5000 100 - 5000 33 - 100 100 - 333 10 - 33 100
TA 1537 10 - 5000 100 - 5000 10 - 100 33 - 333 10 - 33 100
TA 98 10 - 5000 100 - 5000 10 – 100 33 - 333 10 - 33 100
TA 100 10 - 5000 100 - 5000 10 – 100 100 - 333 10 - 33 100
TA 102 3 - 5000 33 - 5000 3 - 100 33 - 333 10 - 33 100
Remarks on result:: other: other: reverse mutation assay
Remarks:: Migrated from field 'Test system'.

Any other information on results incl. tables

Summary of Results Pre-Experiment

Study Name: 1291001	Study Code: Harlan CCR 1291001
Experiment: 1291001 VV Plate	Date Plated: 20/10/2009
Assay Conditions:	Date Counted: 23/10/2009

Metabolic Activation	Test Group	Dose Level (per plate)	Revertant Colony Counts (Mean ±SD)

			TA 1535	TA 1537	TA 98	TA 100	TA 102

Without Activation	Deionised water		17 ± 4	17 ± 2	35 ± 1	153 ± 15	458 ± 6
	Untreated		13 ± 1	12 ± 6	39 ± 11	163 ± 6	452 ± 11
	ALKOXYPROPAN	3 µg	18 ± 5	12 ± 3	31 ± 6	128 ± 11	^{N R}
	DIAMINE	10 µg	10 ± 2^R	1 ± 1^{M R}	6 ± 1^{M R}	27 ± 6^{M R}	0 ± 0^{M R}
	AND	33 µg	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}
	ALKOXYPROPAN	100 µg	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}
	DIAMINEACETATE	333 µg	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}
		1000 µg	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}
		2500 µg	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}
		5000 µg	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}
	NaN3	10 µg	1928 ± 130			2129 ± 120
	4-NOPD	10 µg			356 ± 6
	4-NOPD	50 µg		105 ± 6
	MMS	3.0 µL					3492 ± 696

With Activation	Deionised water		18 ± 5	18 ± 5	47 ± 6	173 ± 10	593 ± 39
	Untreated		17 ± 3	16 ± 4	40 ± 6	177 ± 2	587 ± 40
	ALKOXYPROPAN	3 µg	16 ± 4	18 ± 4	44 ± 6	185 ± 16	565 ± 50
	DIAMINE	10 µg	15 ± 1	19 ± 4	40 ± 10	178 ± 14	565 ± 11
	AND	33 µg	16 ± 3	13 ± 2	22 ± 3^{M R}	138 ± 18	219 ± 15^R
	ALKOXYPROPAN	100 µg	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}
	DIAMINEACETATE	333 µg	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}
		1000 µg	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}
		2500 µg	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}
		5000 µg	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}
	2-AA	2.5 µg	445 ± 31	291 ± 3	2618 ± 50	2688 ± 82
	2-AA	10.0 µg					2314 ± 55

Key to Positive Controls		Key to Plate Postfix Codes

NaN3 2-AA MMS 4-NOPD	sodium azide 2-aminoanthracene methyl methane sulfonate 4-nitro-o-phenylene-diamine	M R P N	Manual count Reduced background growth Precipitate Analysis not possible

Summary of Results Experiment I

Study Name: 1291001	Study Code: Harlan CCR 1291001
Experiment: 1291001 HV1 Plate	Date Plated: 03/11/2009
Assay Conditions:	Date Counted: 06/11/2009

Metabolic Activation	Test Group	Dose Level (per plate)	Revertant Colony Counts (Mean ±SD)

			TA 1535	TA 1537	TA 98	TA 100	TA 102

Without Activation	Deionised water		11 ± 4	11 ± 3	25 ± 7	124 ± 8	371 ± 13
	Untreated		13 ± 2	13 ± 3	23 ± 4	128 ± 6	341 ± 23
	ALKOXYPROPAN	0.01 µg	13 ± 3	8 ± 3	29 ± 1	131 ± 13	408 ± 21
	DIAMINE	0.03 µg	13 ± 2	9 ± 5	27 ± 6	128 ± 7	359 ± 13
	AND	0.1 µg	12 ± 2	12 ± 3	25 ± 3	124 ± 4	375 ± 10
	ALKOXYPROPAN	0.3 µg	13 ± 3	9 ± 1	28 ± 4	119 ± 12	388 ± 10
	DIAMINEACETATE	1 µg	9 ± 1	9 ± 3	25 ± 3	122 ± 3	306 ± 23^R
		3 µg	14 ± 2	8 ± 3	25 ± 5	113 ± 8	56 ± 10^{M R}
		10 µg	6 ± 2^R	0 ± 1^{M R}	5 ± 3^{M R}	29 ± 6^{M R}	0 ± 0^{M R}
		33 µg	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}
		100 µg	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}
	NaN3	10 µg	1812 ± 65			1955 ± 42
	4-NOPD	10 µg			261 ± 4
	4-NOPD	50 µg		68 ± 5
	MMS	3.0 µL					3088 ± 84

With Activation	Deionised water		15 ± 2	17 ± 4	37 ± 5	140 ± 12	551 ± 34
	Untreated		16 ± 2	16 ± 6	35 ± 2	136 ± 17	507 ± 22
	ALKOXYPROPAN	0.03 µg	15 ± 1	15 ± 1	33 ± 7	145 ± 6	577 ± 5
	DIAMINE	0.1 µg	12 ± 3	11 ± 2	34 ± 1	128 ± 17	545 ± 24
	AND	0.3 µg	15 ± 4	13 ± 5	42 ± 5	135 ± 6	579 ± 34
	ALKOXYPROPAN	1 µg	15 ± 4	16 ± 4	37 ± 3	139 ± 8	598 ± 20
	DIAMINEACETATE	3 µg	15 ± 1	15 ± 1	33 ± 8	164 ± 7	569 ± 16
		10 µg	11 ± 3	16 ± 2	38 ± 4	148 ± 12	426 ± 11^R
		33 µg	13 ± 3	7 ± 1^{M R}	14 ± 4^{M R}	106 ± 11	229 ± 12^{M R}
		100 µg	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}
		333 µg	0 ± 0^{M R P}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}	0 ± 0^{P M R}
	2-AA	2.5 µg	313 ± 24	240 ± 18	1766 ± 444	2560 ± 60
	2-AA	10.0 µg					2133 ± 195

Key to Positive Controls		Key to Plate Postfix Codes

NaN3 2-AA MMS 4-NOPD	sodium azide 2-aminoanthracene methyl methane sulfonate 4-nitro-o-phenylene-diamine	M R P	Manual count Reduced background growth Precipitate

Summary of Results Experiment II

Study Name: 1291001	Study Code: Harlan CCR 1291001
Experiment: 1291001 HV2 pre	Date Plated: 16/11/2009
Assay Conditions:	Date Counted: 19/11/2009

Metabolic Activation	Test Group	Dose Level (per plate)	Revertant Colony Counts (Mean ±SD)

			TA 1535	TA 1537	TA 98	TA 100	TA 102

Without Activation	Deionised water		15 ± 6	14 ± 2	32 ± 5	129 ± 17	407 ± 26
	Untreated		12 ± 4	10 ± 2	24 ± 3	139 ± 19	396 ± 16
	ALKOXYPROPAN	0.01 µg	13 ± 2	11 ± 2	29 ± 4	139 ± 18	452 ± 15
	DIAMINE	0.03 µg	16 ± 2	12 ± 2	26 ± 8	127 ± 17	393 ± 28
	AND	0.1 µg	16 ± 2	8 ± 3	35 ± 6	129 ± 14	454 ± 18
	ALKOXYPROPAN	0.3 µg	15 ± 3	13 ± 1	26 ± 5	134 ± 11	420 ± 12
	DIAMINEACETATE	1 µg	11 ± 3	8 ± 2	29 ± 5	120 ± 15	374 ± 3
		3 µg	13 ± 4^R	9 ± 3^R	25 ± 5^R	78 ± 9^R	231 ± 34^R
		10 µg	1 ± 1^{M R}	0 ± 0^{M R}	3 ± 1^{M R}	14 ± 5^{M R}	0 ± 0^{M R}
		33 µg	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}
	NaN3	10 µg	1804 ± 30			1791 ± 115
	4-NOPD	10 µg			349 ± 53
	4-NOPD	50 µg		71 ± 6
	MMS	3.0 µL					3068 ± 246

With Activation	Deionised water		21 ± 3	15 ± 2	35 ± 4	170 ± 8	626 ± 29
	Untreated		16 ± 6	14 ± 1	45 ± 6	168 ± 31	570 ± 51
	ALKOXYPROPAN	0.03 µg	18 ± 4	16 ± 3	39 ± 7	153 ± 11	658 ± 26
	DIAMINE	0.1 µg	19 ± 4	15 ± 1	35 ± 3	154 ± 18	637 ± 16
	AND	0.3 µg	23 ± 3	13 ± 2	42 ± 11	156 ± 7	646 ± 18
With Activation	ALKOXYPROPAN	1 µg	22 ± 2	22 ± 3	40 ± 9	162 ± 11	586 ± 57
	DIAMINEACETATE	3 µg	25 ± 2	13 ± 6	34 ± 7	145 ± 6	570 ± 27
		10 µg	20 ± 7	15 ± 3	42 ± 7	150 ± 7	498 ± 51
		33 µg	15 ± 4^R	11 ± 1^R	31 ± 3^R	120 ± 10^R	283 ± 15^R
		100 µg	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}	0 ± 0^{M R}
	2-AA	2.5 µg	348 ± 21	292 ± 29	2258 ± 171	2448 ± 127
	2-AA	10.0 µg					2907 ± 730

Key to Positive Controls		Key to Plate Postfix Codes

NaN3 2-AA MMS 4-NOPD	sodium azide 2-aminoanthracene methyl methane sulfonate 4-nitro-o-phenylene-diamine	R M	Reduced background growth Manual count

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In conclusion, it can be stated that during the described mutage¬nicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.

Executive summary:

This study was performed to investigate the potential of Alkoxypropandiamine and Alkoxypropandiamineacetate to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and TA 102.

The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:

Pre-Experiment: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate

Experiment I
without S9 mix: 0.01; 0.03; 0.1; 0.3; 1; 3; 10; 33; and 100 µg/plate
with S9 mix: 0.03; 0.1; 0.3; 1; 3; 10; 33; 100; and 333 µg/plate

Experiment II
without S9 mix: 0.01; 0,03; 0.1; 0.3; 1; 3; 10; and 33 µg/plate
with S9 mix: 0.03; 0.1; 0.3; 1; 3; 10; 33; and 100 µg/plate

The plates incubated with the test item showed reduced background growth with and without S9 mix in all strains used.

Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation.

No substantial increase in revertant colony numbers of any of the fivetester strains was observed following treatment with Alkoxypropandiamine and Alkoxypropandiamineacetate at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.

Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.

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1,3-Propanediamine, N-[3-((C11-14, C13-rich)oxy)propyl]- branched acetate

Genetic toxicity: in vitro

Administrative data

Data source

Reference

Materials and methods

Test guideline

Test material

Test material information

Constituent 1

Constituent 2

Method

Species / strain

Controls

Results and discussion

Test resultsopen all close all

Test results 1

Test results 2

Test results 3

Test results 4

Test results 5

Any other information on results incl. tables

Group

Applicant's summary and conclusion

Registration Dossier

Registration Dossier

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Diss Factsheets

1,3-Propanediamine, N-[3-((C11-14, C13-rich)oxy)propyl]- branched acetate

Genetic toxicity: in vitro

Administrative data

Data source

Reference

Materials and methods

Test guideline

Test material

Test material information

Constituent 1

Constituent 2

Method

Species / strain

Controls

Results and discussion

Test resultsopen allclose all

Test results 1

Test results 2

Test results 3

Test results 4

Test results 5

Any other information on results incl. tables

Group

Applicant's summary and conclusion

Test resultsopen all close all