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Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
reproductive toxicity, other
Remarks:
other: various
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: The EU RAR summarises the results of a number of studies of largely non-standard design and variable reliability. The findings of these studies are, however, consistent with each other.

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 (Munn SJ et al; eds.)
Year:
2005
Bibliographic source:
3rd Priority List; Volume 53

Materials and methods

Principles of method if other than guideline:
The EU RAR summarises the findings of a number of studies designed to investigate the effects of potassium dichromate on the fertility of male and/or female mice following administration in drinking water.
GLP compliance:
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:
sodium dichromate
Details on test material:
The test substance was purchased from Aldrich Chemical Corp. and provided by the NTP through Research Triangle Institute (RTI), (Research Triangle Park, North Carolina). All bulk chemical analyses and test formulations analyses were conducted by RTI. Prior to the initiation of dosing, two 5 g samples of the bulk test article were collected into amber glass bottles with Teflon coated lids, sealed and stored in the freezer protected from light for possible analysis. A bulk test article of 5 g was collected and sent to RTI for purity and stability testing within 30 days of receipt. The compound was analyzed at RTI upon receipt from the vendor, Aldrich and the relative purity was determined to be approx. 99%, based on potassium content. The identity and purity of the compound was confirmed by infrared spectrometry and inductively coupled plasma emission spectrometry (ICP). A bulk chemical reanalysis was sent on May 9, 1995 and analyzed on August 16, 1995. The relative purity was determined to be 98.5% based on potassium content.

Test animals

Species:
mouse
Strain:
other: Various
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Details on mating procedure:
Various
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
Various
Frequency of treatment:
Various
Details on study schedule:
Various
No. of animals per sex per dose:
Various

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Remarks on result:
other: See "Any other information on results incl. tables" below.

Results: F1 generation

Effect levels (F1)

Remarks on result:
other: See "Any other information on results incl. tables" below.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Adverse effects were produced in mice receiving potassium dichromate for 12 weeks in drinking water at 333 mg/kg bw/d (120 mg Cr(VI)/kg bw/d) and 400 mg/kg bw/day (140 mg Cr(VI)/kg bw/d) and above in males and females respectively. An increase in resorptions following treatment of males and a decrease in implantations in treated females were among the findings in this study. In another study, pregestational oral administration of potassium dichromate in drinking water to female mice produced adverse effects on fertility (reduced number of corpora lutea and increased pre-implantation loss) at 500 ppm (119 mg/kg bw/d (40 mg Cr(VI)/kg bw/d)) and above. In a third study, also in the mouse, at 86 mg/kg bw/d (30 mg Cr(VI)/kg bw/d), the highest dose level tested, there were no effects of treatment on fertility parameters.

Applicant's summary and conclusion

Conclusions:
The available data show that potassium dichromate, administered in the drinking water, has adverse effects on reproduction in the mouse.
Executive summary:

The results of studies performed using the administration of potassium dichromate in drinking water show adverse effects on the fertility of male and female mice. Based on the comparable toxicokinetics and toxicodynamics of the water-soluble hexavalent chromium compounds; similar toxicity can be assumed for all of the compounds in this group.