Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
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 resulys of the studies are consistent.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The EU RAR reports the findings of a number of different studies.
GLP compliance:
yes
Remarks:
one study

Test material

Constituent 1
Reference substance name:
Chromium
EC Number:
231-157-5
EC Name:
Chromium
Cas Number:
7440-47-3
Molecular formula:
Cr
IUPAC Name:
chromium

Test animals

Species:
mouse
Strain:
other: various

Administration / exposure

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)

Remarks on result:
not measured/tested
Remarks:
summary of studies

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
LOAEL
Effect level:
60 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: not specified

Overall developmental toxicity

Developmental effects observed:
yes
Lowest effective dose / conc.:
60 mg/kg bw/day (nominal)
Treatment related:
not specified
Relation to maternal toxicity:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

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.