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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro DNA damage and/or repair study
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. The summary report is taken from IPCS Environmental Health Criteria 172 (WHO), which is a relayble internationally accepted sorce. The justification for the Read Across approach has been attached to the Section 13

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Tetrabromobisphenol A and Derivatived (Environmental health criteria ; 172).
Author:
G.J. van Esch
Year:
1995
Bibliographic source:
World Health Organization; IPCS
Reference Type:
other: Secondary Source
Title:
In vitro sister chromatid exchange in Chinese hamster ovary cells with GLCC 785-104C
Author:
Cavagnaro J & Cortina TA
Year:
1984
Bibliographic source:
Vienna, Virginia, Hazleton Biotechnologies Corporation

Materials and methods

Principles of method if other than guideline:
No available information on method used.
GLP compliance:
not specified
Type of assay:
sister chromatid exchange assay in mammalian cells

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Details on mammalian cell type (if applicable):
No data available
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
No data available
Test concentrations with justification for top dose:
5, 17, 50, 170, and 500 µg/ml
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
not specified
Details on test system and experimental conditions:
DURATION
- Exposure duration: 2 hours
- Expression time (cells in growth medium): 24 hours

Results and discussion

Test results
Species / strain:
not specified
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No statistically significant increases in the number of exchanges per chromosome or the number of exchanges per cell were seen at any of the levels tested, either with, or without, metabolic activation.

Any other information on results incl. tables

At dosing, it was noted that the culture medium became cloudy at 170 µg/ml and that the compound precipitated at 500 µg/ml.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Not Mutagenic
Executive summary:

References

The evaluation of Genetic toxicity reported from Cavagnaro J & Cortina TA (1984)[1] in the WHO publication[2] has been considered in order to complete the assessment.

Method and observations

Chinese hamster ovary cells (CHO, K-1, number CCL61) were exposed to 5 concentrations of the substance in DMSO (5, 17, 50, 170, and 500 µg/ml) for 2 h in the presence, or absence, of metabolic activation followed by a 24 h expression period in comparison with solvent and positive controls. At dosing, it was noted that the culture medium became cloudy at 170 µg/ml and that the compound precipitated at 500 µg/ml.

Results

No statistically significant increases in the number of exchanges per chromosome or the number of exchanges per cell were seen at any of the levels tested, either with, or without, metabolic activation. The substance is considered to be negative in this system

 

[1]Cavagnaro J & Cortina TA (1984) In vitrosister chromatid exchange in Chinese hamster ovary cells with GLCC 785-104C (Final report). Vienna, Virginia, Hazleton Biotechnologies Corporation (Report to Great Lakes Chemical Corporation, West Lafayette, submitted to WHO by the Brominated Flame Retardant Industry Panel).

[2]World Health Organization (WHO, Geneva, 1995); Dr. G.J. van Esch “Tetrabromobisphenol A and Derivatived” (Environmental health criteria; 172)