3-(amidinothio)propionic acid

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

Study period:

1996-05-07 to 1996-05-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-(amidinothio)propionic acid

EC Number:

226-430-0

EC Name:

3-(amidinothio)propionic acid

Cas Number:

5398-29-8

Molecular formula:

C4H8N2O2S

IUPAC Name:

3-(carbamimidoylsulfanyl)propanoic acid

Details on test material:

- Substance type: organic
- Physical state: white powder
- Purity: as specified in section 1.1 and 1.2
- Storage condition of test material: at room temperature

Method

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S9 mix

Test concentrations with justification for top dose:

Experiment 1 and 2: 20, 100, 500, 2500, 5000 µg/plate

Vehicle / solvent:

DMSO
- Vehicle used: DMSO

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

with S9 mix (TA100, TA98, TA1537, TA 1535, WP2 uvrA)

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: N-methyl-N-nitro-N-nitrosoguanidine

Remarks:

without S9 mix (TA100, TA1535)

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylendiamine

Remarks:

without S9 mix (TA98)

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without S9 mix (TA1537)

Controls 5

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: N-methyl-N-nitro-N-nitrosoguanidine

Remarks:

without S9 mix (WP2 uvrA)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 - 72 hours

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: other: reduced background lawn

Evaluation criteria:

In general, a substance to be characterized as positive in the bacterial tests has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Results and discussion

Test results

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
- Precipitation: No test substance precipitation was found.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
No bacteriotoxic effect (reduced his or trp background growth) was observed.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Raw data

Experiment 1 (Standard Plate test)
Dose (µg/plate)	Mean number of revertant colonies/3 replicate plates with different strains of Salmonella typhimurium and Escherichia coli
	TA1535	TA1537	TA98	TA100	WP2 uvrA
	Results with S9
Spontaneous Reversion	20	7	35	120	49
Positive control	206	116	828	1064	176
20	16	7	38	112	44
100	18	7	29	110	46
500	20	7	27	93	47
2500	12	6	26	97	42
5000	13	6	30	79	41
	Results without S9
Spontaneous Reversion	20	7	23	106	44
Positive control	1430	658	1150	986	795
20	16	7	26	114	41
100	16	5	20	108	45
500	18	5	19	107	38
2500	19	7	20	118	44
5000	16	6	25	116	40
Experiment 2 (Pre-incubation test)
Dose (µg/plate)	Mean number of revertant colonies/3 replicate plates with different strains of Salmonella typhimurium and Escherichia coli
	TA1535	TA1537	TA98	TA100	WP2 uvrA
	Results with S9
Spontaneous Reversion	22	12	45	121	41
Positive control	137	111	675	782	208
20	20	13	48	113	35
100	19	9	45	124	39
500	20	11	41	118	32
2500	20	8	37	99	32
5000	19	7	39	107	35
	Results without S9
Spontaneous Reversion	21	6	32	116	44
Positive control	868	632	1097	1119	791
20	20	6	33	114	45
100	16	4	33	123	38
500	20	4	38	115	41
2500	16	4	33	117	40
5000	19	4	35	110	38

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative