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Toxicological information

Genetic toxicity: in vitro

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978
Reference Type:
publication
Title:
RISK ASSESSMENT of 2,2’,6,6’-TETRABROMO-4,4’-ISOPROPYLIDENE DIPHENOL.
Author:
EU risk assessment: United Kingdom (TBBPA)
Year:
2008
Bibliographic source:
Environment Agency Chemicals Assessment Section United Kingdom
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

10g

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.