Registration Dossier

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
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:
Unscheduled DNA synthesis rat hepatocyte assay, GLCC 785-104C
Author:
Cavagnaro J & Sernau RC
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:
unscheduled DNA synthesis

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Administration / exposure

Route of administration:
other: No data available
Vehicle:
DMSO
Details on exposure:
No data available
Duration of treatment / exposure:
No data available
Frequency of treatment:
No data available
Post exposure period:
No data available
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
10 µg/l
Basis:
no data
Remarks:
Doses / Concentrations:
50 µg/l
Basis:
no data
Remarks:
Doses / Concentrations:
100 µg/l
Basis:
no data
Remarks:
Doses / Concentrations:
500 µg/l
Basis:
no data
Remarks:
Doses / Concentrations:
1000 µg/l
Basis:
no data
No. of animals per sex per dose:
No data available
Control animals:
yes
Positive control(s):
Positive medium and solvent controls

Examinations

Tissues and cell types examined:
No data available
Details of tissue and slide preparation:
No data available
Evaluation criteria:
No data available
Statistics:
No data available

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
valid

Any other information on results incl. tables

No significant increase in the mean nuclear grain count was observed at any dose level compared with the solvent control.

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 & Sernau, 1984) [1] in the WHO publication[2] has been considered in order to complete the assessment.

Method and observations

The substance was tested in rats (Sprague-Dawley) by means of unscheduled DNA Synthesis Assay in duplicate doses of 10, 50, 100, 500, and 1000 µg/ml. The high dose was selected on the basis of the solubility of the substance in DMSO. Positive medium and solvent controls confirmed the sensitivity of the system

Results

No significant increase in the mean nuclear grain count was observed at any dose level compared with the solvent control.

[1] Cavagnaro J & Sernau RC (1984) Unscheduled DNA synthesis rat hepatocyte assay, 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)