1,18-octadecanedioic 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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Valid without restriction. Well documented GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,18-octadecanedioic acid

EC Number:

442-490-2

EC Name:

1,18-octadecanedioic acid

Cas Number:

871-70-5

Molecular formula:

C18H34O4

IUPAC Name:

octadecanedioic acid

Constituent 2

Reference substance name:

Octadecanedioic acid

EC Number:

617-978-5

IUPAC Name:

Octadecanedioic acid

Test material form:

solid: flakes

Details on test material:

Purity: 100% active matter
Remarks: White, solid.
Solubility: Poorly soluble (=< 2 mg/L in test medium).
Carbon chain length distribution: C16 2,98%, C18 92,9%, C18:1 1,04%

Method

Metabolic activation:

with and without

Metabolic activation system:

500 μl

Test concentrations with justification for top dose:

33, 100, 333, 1000, 2500, 5000 μg/plate

Controls

Untreated negative controls:

yes

Positive controls:

yes

Remarks:

without metabolic activation, treated with sodium azide, 4-nitro-o-phenylene-diamine and methyl methane sulfonate with metabolic activation, treated with 2-aminoanthracene

Remarks:

Sodium azide (10 ug/plate): TA 1535 & 1004-nitro-o-phenylene-diamine: TA 1537 (50 ug/plate), TA 98 (10 ug/plate) Methyl-methane-sulfonate (5 ul/plate): TA 102 2-aminoanthracene: TA 1535, 1537, 98 & 100 (2.5 ug/plate), TA 102 (10 ug/plate)

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:

other: Without metabolic activation: 5000 μg/plateWith metabolic activation: 2500-5000 μg/plate

Any other information on results incl. tables

Toxicity effects

Strain	Experiment I (¼g/plate)		Experiment II (¼g/plate)
	Without S-9 Mix	With S-9 Mix	Without S-9 Mix	With S-9 Mix
TA 1535	5000	--	--	--
TA 1537	5000	2500 - 5000	--	5000
TA 98	--	5000	--	--
TA 100	--	--	--	--
TA 102	--	5000	--	--

Summary of Results without S-9 Mix

Concentration (¼g/plate)	Revertants/plate (mean from three plates)
	TA 98		TA 100		TA 102		TA 1535		TA 1537
	I	II	I	II	I	II	I	II	I	II
Negative Control	23	25	142	158	270	280	13	20	5	11
Solvent Control	20	20	157	164	247	240	13	20	5	9
Positive Control[1]	198	198	656	997	1063	1005	907	710	56	60
33	19	19	152	124	239	239	13	16	4	8
100	20	20	147	125	256	256	13	18	6	9
333	21	21	163	105	316	293	17	18	5	6
1000	20	20	175	133	250	292	14	19	5	8
2500	19	19	146	122	304	296	11	18	4	7
5000	10	10	136	123	172	193	5	12	0	6

 

Summary of Results with S-9 Mix

Concentration (¼g/plate)	Revertants/plate (mean from three plates)
	TA 98		TA 100		TA 102		TA 1535		TA 1537
	I	II	I	II	I	II	I	II	I	II
Negative Control	21	38	169	157	366	255	10	19	4	18
Solvent Control	26	40	220	158	431	221	14	18	9	14
Positive Control[2]	509	346	907	486	979	748	110	123	95	52
33	27	32	190	149	313	272	14	19	5	13
100	22	39	208	133	200	266	13	19	6	12
333	27	33	219	140	366	274	15	14	4	12
1000	26	37	225	150	299	288	12	16	6	9
2500	16	29	215	183	229	298	23	16	1	9
5000	6	28	177	128	191	185	9	11	0	6

[1]Sodium azide (10 ug/plate): TA 1535 & 100

4-nitro-o-phenylene-diamine: TA 1537 (50 ug/plate), TA 98 (10 ug/plate)

Methyl-methane-sulfonate (5 ul/plate): TA 102

[2]2-aminoanthracene: TA 1535, 1537, 98 & 100 (2.5 ug/plate), TA 102 (10 ug/plate)

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Not mutagenic