2-Propanol, 1,1'-(tridecylimino)bis-

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: Guideline study with acceptable restrictions (missing strain for crosslinking/oxidizing agents), no GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

missing strain for crosslinking/oxidizing agents

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Batch No.: P.7038

Method

Target gene:

his+

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:

S9 mix from Aroclor 1254 treated rats

Test concentrations with justification for top dose:

1st experiment (Standard Plate):
TA 100, TA 98: Doses : 0, 20, 100, 500, 2500 and 5000 µg/plate
2nd experiment (Standard Plate):
TA 1535, TA 100, TA 1537, TA 98 Doses : 0, 0.8, 4, 20, 100 and 500 µg/plate
3rd experiment (Preincubation):
TA 1535, TA 100, TA 1537, TA 98 Doses : 0, 0.8, 4, 20, 100 and 250 µg/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: +S9: 2-aminoanthracene for all strains; -S9: N-methyl-N-nitro-N-nitrosoguanidine for the strains TA 100 and TA 1535; 4-nitro-o-phenylendiamine for the strain TA 98; 9-aminoacridine chloride monohydrate for TA 1537

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (standard plate incubation test); preincubation (Preincubation test)
- Preincubation period: 20 min

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:

A cytotoxic effect was observed depending on the strain and test conditions in the standard plate test from about 100 µg - 500 µg/plate onward and in the preincubation test from about 100 - 250 µg/plate onward.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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: Number of revertants of vehicle control and treatment groups in the standard plate and preincubation test.

		STANDARD PLATE TESTS		PREINCUBATION TEST
Strain	S9 mix	Number of Revertants in Vehicle Control	Maximal number of Revertants (dose µg/plate)	Number of Revertants in Vehicle Control	Maximal number of Revertants (dose µg/plate)
T100*	-	96 / 93	97 (20) / 99 (20)	101	92 (4)
	+	91/ 116	99 (100) / 128 (4)	110	109 (20)
T98*	-	21/ 22	24 (100)/ 22 (0.8)	19	17 (0.8)
	+	33/35	32 (0.8)/ 33 (0.8)	31	27 (20)
T1535	-	18	18 (20)	17	15 (20)
	+	21	27 (20)	21	17 (100)
T1537	-	6	8 (0.8)	7	7 (0.8/4)
	+	13	10 (0.8/20)	8	9 (0.8)

* Results of two standard plate tests depicted