Disodium sebacate

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:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

According to Ames et al., Mut. Res., 31, 1975

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sebacic acid

EC Number:

203-845-5

EC Name:

Sebacic acid

Cas Number:

111-20-6

Molecular formula:

C10H18O4

IUPAC Name:

sebacic acid

Test material form:

solid: bulk

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source of test material: Tokyo Kasei Kogyo Co. LTD. Tokyo, Japan.

Method

Target gene:

S. typhimurium: his-
E. coli: trp-

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Remarks:

S. typhimurium TA 1538 / E.coli WP2 uvrA

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

1, 5, 10, 50, 100, 500, 1000, and 5000 µg/plate

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2 -(2 furyl)-3 -(5 -nitro-2 -furyl) acrylamide (AF2)

Remarks:

0.01 µg/plate for TA100, 0.05 µg/plate for WP 2 uvrA and TA 98, without S9-mix

Controls 2

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

5 µg/plate for TA1535 and for TA1535, without S9-mix

Controls 3

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

80 µg/plate for TA1537, without S9-mix

Controls 4

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

0.25 µg/plate for TA1538, without S9-mix

Controls 5

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

5 µg/plate for TA1535 and WP2 uvrA, with S9-mix

Controls 6

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

5 µg/plate for TA100, TA98, TA1537, TA1538, with S9-mix

Details on test system and experimental conditions:

METHOD OF APPLICATION:
- preincubation, added to a minimal glucose agar plate

DURATION
- Preincubation period: 20 min

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Test results 6

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Any other information on results incl. tables

SUMMARY OF RESULTS

Compound	Dose (µg/plate)	TA100		TA1535		WP2 uvrA		TA98		TA1537		TA1538
		-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
		Revertant Colonies
DMSO		150	154	30	15	30	34	32	42	18	22	22	28
AF-2	0.01	501
AF-2	0.05					1082		278
ENNG	5.0			1101
9AC	80.0									889
4NQO	0.25											270
B(a)P	5.0		1084						809		313		354
2AA	5.0				440		359
Sebacic Acid	1	130	130	29	9	17	26	43	49	17	23	23	38
	5	119	138	34	11	24	22	52	50	13	25	26	38
	10	131	130	26	15	23	27	39	46	14	24	31	33
	50	125	123	34	13	18	24	47	56	11	24	27	33
	100	136	119	36	16	26	29	50	47	13	29	36	39
	500	140	122	28	13	24	32	42	56	11	18	20	34
	1000	127	132	26	12	27	23	34	45	18	12	28	33
	5000	112	134	36	14	24	27	45	47	12	20	30	32