Registration Dossier

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: other: Various methods
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The EU RAR summarises the results of a number of studies of various designs and reilability.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: EU RAR
Title:
European Union Risk Assessment Report: chromium trioxide, sodium chromate, sodium dichromate, ammonium dichromate, potassium dichromate
Author:
European Chemicals Bureau
Year:
2005
Bibliographic source:
3rd Priority List; Volume 53

Materials and methods

Principles of method if other than guideline:
The EU RAR reports the results of a number of studies of various designs.
GLP compliance:
no
Remarks:
Largely literature studies
Type of assay:
other: Various methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
No further details; some studies were also performed using potassium chromate - results can be extrapolated to the compounds in this group.

Test animals

Species:
other: Rats and mice
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: various
Duration of treatment / exposure:
Various treatment schedules were used
Frequency of treatment:
Various treatment schedules were used
Post exposure period:
Various protocols
No. of animals per sex per dose:
Various protocols were used

Examinations

Tissues and cell types examined:
Vartious: including bone marrow, liver, kidney, lung and germ cells

Results and discussion

Any other information on results incl. tables

Parenteral administration of sodium or potassium dichromate or potassium chromate to rats or mice resulted in significant increases in chromosome aberrations and micronucleated cells in the bone marrow and DNA single-strand breaks, interstrand cross-links and DNA-protein cross-links in the liver, kidneys and lung. A mouse spot test involving intraperitoneal injection of potassium chromate gave positive results. Oral studies have been negative but these employed lower dose levels and absorption is known to be poor by the oral route. Overall, it was concluded that water soluble Cr (VI) compounds are in vivo somatic cell mutagens in animal studies. A significant increase in post implantation deaths in a dominant lethal assay was reported in mice following intraperitoneal injection of potassium dichromate.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): positive
The EU RAR concludes, on the basis of the available information, that water-soluble Cr (VI) compounds are genotoxic in vivo in somatic cells and in germ cells.
Executive summary:

The EU RAR summarises the results of a number of studies of genotoxicity in vivo of various designs and different reliability. It is concluded, based on the weight of evidence, that water-soluble Cr (VI) compounds are genotoxic in vivo in somatic cells and in germ cells.