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Toxicological information

Developmental toxicity / teratogenicity

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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:
2005
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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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
Constituent 3
Reference substance name:
Sodium dichromate dihydrate
IUPAC Name:
Sodium dichromate dihydrate
Details on test material:
No further details

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.