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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
genetic toxicity in vitro
Remarks:
Type of genotoxicity: other: Various in vitro methods are reviewed
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
Not applicable
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The EU RAR summarises a very large number of genotoxicity studies of varying quality and largely performed to non-standard designs. However the consistently positive responses mean that the studies taken as a whole are reliable. The RAR also covers studies discussed in earlier reviews by the UK HSE (1989) and the UK IOH (1997).

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

Test guideline
Qualifier:
no guideline followed
Deviations:
not applicable
Principles of method if other than guideline:
The EU RAR summarises the results of a large number of studies in vitro performed using chromium (VI) compounds, to various (and largely non-standard) protocols.
GLP compliance:
not specified
Remarks:
Mainly published studies
Type of assay:
other: Various in vitro methods are reviewed

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
No further details

Method

Target gene:
Various
Species / strain
Species / strain / cell type:
other: various
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Various
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
Not reported for individual studies
Evaluation criteria:
Not reported for individual studies
Statistics:
Not reported for individual studies

Results and discussion

Test results
Species / strain:
other: various
Metabolic activation:
with and without
Genotoxicity:
positive
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:
The results of a very large number of studies performed in vitro with the water-soluble hexavlent chromium compounds are largely positive.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The results of a very large number of studies performed in vitro with the water-soluble hexavlent chromium compounds are largely positive.

The EU RAR therefore concludes that there is a very large body of evidence indicating that the Cr (VI) ion in solution is directly mutagenic in in vitro systems; this conclusion is relevant to all compounds in this group.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive weight of evidence approach

The weight of evidence in various test systems indicates that water soluble Cr (VI) compounds in this group are genotoxic in vitro.
Executive summary:

The EU RAR summarises the results of a number of in vitro studies of various designs and reliability performed over a number of years. The RAR itself also takes into account the findings of the earlier reviews of the toxicity of Cr (VI) compounds by the UK Health & Safety Executive (HSE, 1989) and the UK Institute of Health (IOH, 1997), which came to similar conclusions. It is concluded that water soluble Cr (VI) compounds are genotoxic in vitro.