2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol

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:

January - August 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP data; conducted according to generally accepted guidelines; no analytical verification of test compound concentrations.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

Pre-dates OECD guidelines

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Tetrabromobisphenol-A, TBBA
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): see Fig. N/A
- Substance type: Monconstituent
- Physical state: Not reported, solid?
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components: Not reported
- Isomers composition: Not reported
- Purity test date: Not reported
- Lot/batch No.: Not reported, received from Dead Sea Bromine Co
- Expiration date of the lot/batch: Not reported
- Radiochemical purity (if radiolabelling): N/A
- Specific activity (if radiolabelling): N/A
- Locations of the label (if radiolabelling): N/A
- Expiration date of radiochemical substance (if radiolabelling): N/A
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

N/A

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Test concentrations with justification for top dose:

1, 10, 100 ug TBBA per plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: N-methyl-N-nitroso-N-nitrosoguanidine and acridine orange

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION: Not reported

SELECTION AGENT (mutation assays): Rat liver microsomes from anaimal injected with Arochlor 1254

NUMBER OF REPLICATIONS: Two

NUMBER OF CELLS EVALUATED: Not reported

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

Yield colony counts

Statistics:

None

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:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: Not measured
- Effects of osmolality: Not measured
- Evaporation from medium: Not measured
- Water solubility: Not reported
- Precipitation: At concentrations exceeding highest dose tested
- Other confounding effects: None reported

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Mutagenic Activity of TBBA using S. typimurium Test strains

			Number of relevant colonies per plate
Type	Tissue	Dose	TA98		TA100		TA1535		TA1537
Solvent control	--	DMSO	46	34	200	300	151	108	1	0
Solvent control	Liver	DMSO	79	64	240	300	44	34	7	9
Positive control	--	20µg AO	33	33
Positive control	Liver	20µg AO	1270	1961	1208	1136			129	100
Positive control	--	10µg MNNG			10000		13000	15072
TBBA	--	1µg	47	37	249	178	116	128	6	5
TBBA	Liver	1µg	86	84	245	209	42	32	8	6
TBBA	--	10µg	23	45	212	218	98	89	8	14
TBBA	Liver	10µg	82	72	287	306	40	60	15	8
TBBA	--	100µg	45	51	45	51	85	83	6	1
TBBA	Liver	100µg	83	96	150	211	29	33	7	11

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The results show that tetrabromobisphenol-A at 1, 10, and 100 micrograms per plate are not mutagenic, since all strains yield colony counts that are not significantly different from the comparable control counts. Higher concentrations were not tested due to poor solubility of the test substance andprecipitation on the plates at doses higher than 100 ug per plate.

Executive summary:

The results show that tetrabromobisphenol-A at 1, 10, and 100 micrograms per plate are not mutagenic, since all strains yield colony counts that are not significantly different from the comparable control counts.