Registration Dossier
Registration Dossier
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EC number: 234-190-3 | CAS number: 10588-01-9
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The EU RAR summarises the findings of a number of studies performed to various guidelines. However the results of the studies are consistent.
Data source
Reference
- Reference Type:
- other: review
- Title:
- European Union Risk Assessment Report: chromium trioxide, sodium chromate, sodium dichromate, ammonium dichromate and potassium dichromate
- Author:
- European Chemicals Bureau
- Year:
- 2 005
- Bibliographic source:
- 3rd. Priority List; Volume 53
Materials and methods
- Principles of method if other than guideline:
- The EU RAR reports the findings of a number of different studies.
- GLP compliance:
- no
- Remarks:
- One of the studies is GLP-compliant
- Limit test:
- no
Test material
- 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:
- potassium dichromate
- Reference substance name:
- Chromium trioxide
- EC Number:
- 215-607-8
- EC Name:
- Chromium trioxide
- Cas Number:
- 1333-82-0
- Molecular formula:
- CrO3
- IUPAC Name:
- Trioxochromium
- Reference substance name:
- Sodium dichromate dihydrate
- IUPAC Name:
- Sodium dichromate dihydrate
- Details on test material:
- No further details
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- mouse
- Strain:
- other: various
Administration / exposure
- Route of administration:
- oral: drinking water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Various study designs
- Duration of treatment / exposure:
- Various study designs
- Frequency of treatment:
- Various study designs
- Duration of test:
- Various study designs
- No. of animals per sex per dose:
- Various study designs
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- other: No maternal effect level identified in the report
- Remarks on result:
- not measured/tested
- Remarks:
- No maternal effect level identified in the report, significant developmental effects observed in the absence of maternal toxicity (60 mg potassium dichromate/kg bw/d)
Results (fetuses)
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 60 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- potassium dichromate
- Basis for effect level:
- other: fetotoxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 63 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- potassium dichromate
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Key result
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 60 mg/kg bw/day
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects in the absence of maternal toxicity effects
Any other information on results incl. tables
Foetotoxicity, including post-implantation losses, was observed in the mouse following the administration of potassium dichromate in drinking water during gestation (days 0-19). Significant developmental effects occurred at the lowest dose level tested, 60 mg/kg bw/d (20 mg Cr(VI)/kg bw/d) in the absence of maternal toxicity. Qualitatively similar results were obtained in another study in which (350 mg/kg bw/d) potassium dichromate (125 mg Cr(VI)/kg bw/d) was administered for a shorter period, on days 6-14 of gestation. In a pregestational study in female mice, fetotoxic effects were seen starting from the lowest dose level tested, 250 ppm (63 mg/kg bw/d (22.1 mg Cr(VI)/kg bw/d)) potassium dichromate. Significant levels of total chromium were found in treated animals at sacrifice.
Applicant's summary and conclusion
- Conclusions:
- The results of these studies indicate that potassium dichromate is a developmental toxin following administration to the mouse. Given the comparable toxicokinetics, similar toxicity is assumed for the other water-soluble Cr (VI) compounds in this group.
- Executive summary:
The results of developmental toxicity studies of various designs and reliabilities performed in the mouse with potassium dichromate show that this compound is a developmental toxin; similar activity is assumed for the other compounds in this group.
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