Registration Dossier
Registration Dossier
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EC number: 232-140-5 | CAS number: 7789-00-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- genetic toxicity in vitro, other
- 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:
- 2 (reliable with restrictions)
- 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:
- 2 005
- Bibliographic source:
- 3rd Priority List; Volume 53
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- 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 substance name:
- Chromium trioxide
- EC Number:
- 215-607-8
- EC Name:
- Chromium trioxide
- Cas Number:
- 1333-82-0
- IUPAC Name:
- 1333-82-0
- Reference substance name:
- Sodium chromate
- EC Number:
- 231-889-5
- EC Name:
- Sodium chromate
- Cas Number:
- 7775-11-3
- Molecular formula:
- CrH2O4.2Na
- IUPAC Name:
- disodium dioxido(dioxo)chromium
- Reference substance name:
- Sodium dichromate
- EC Number:
- 234-190-3
- EC Name:
- Sodium dichromate
- Cas Number:
- 10588-01-9
- Molecular formula:
- Cr2Na2O7
- IUPAC Name:
- sodium dichromate
- Reference substance name:
- Potassium dichromate
- EC Number:
- 231-906-6
- EC Name:
- Potassium dichromate
- Cas Number:
- 7778-50-9
- Molecular formula:
- Cr2H2O7.2K
- IUPAC Name:
- sodium dichromate
- Details on test material:
- No further details
Constituent 1
Constituent 2
Constituent 3
Constituent 4
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
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 the results:
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.
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