Diisopropyl sebacate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline with acceptable restrictions (TA1535 was not included, no positive controls); only available in Japanese

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity of Plastic Additives

Author:

Hachiya, N. and Takizawa, Y.

Year:

1994

Bibliographic source:

Hen'igensei Shiken 3(3):147-154

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

TA1535 was not included. No positive controls.

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyl sebacate

EC Number:

203-672-5

EC Name:

Dibutyl sebacate

Cas Number:

109-43-3

IUPAC Name:

dibutyl sebacate

Details on test material:

- Name of test material (as cited in study report): dibutyl sebacate
- Analytical purity: no data

Method

Target gene:

His operon (S. typhimurium strains) and trp operon (E. coli strain)

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium, other: TA97, TA98, TA100, TA102

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Metabolic activation system:

cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254

Test concentrations with justification for top dose:

0, 200, 500, 1000, 2000, 5000, 10000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO supplemented with Tween 80

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

no

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 44 - 46 hours

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium, other: TA97, TA98, TA100, TA102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

not examined

Test results 2

Species / strain:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

not examined

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation

ADDITIONAL INFORMATION ON CYTOTOXICITY:
No growth inhibition was detected.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1. Test results of bacterial reversion assays on dibutyl sebactate

Dose µg/plate	TA97		TA98		TA100		TA102		E. coli WP2/pKM101
	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
0	81	171	16	24	124	109	85	109	53	68
200	81	155	16		116	109	83	87	56	68
500	104	176	17	19	126	120	72	94	55	67
1000	99	137	16	30	127	115	82	111	58	70
2000	114	138	23	26	131	104	106	103	62	70
5000	96	155	15	26	103	116	68	64	52	83
10000	88	150	14	22	86	115	81	71	65	77

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative