Registration Dossier

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
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:
Unnamed
Year:
2005

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:
yes
Remarks:
(one study is GLP-compliant)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No further details

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)

open allclose all
Dose descriptor:
NOAEL
Effect level:
166 mg/kg bw/day (actual dose received)
Sex:
male
Basis for effect level:
other: First study; Potassium dichromate, mice
Remarks on result:
other: Generation not specified (migrated information)
Dose descriptor:
LOAEL
Effect level:
333 mg/kg bw/day
Sex:
male
Basis for effect level:
other: First study; 12 week dose, potassium dichromate in mice
Remarks on result:
other: Generation not specified (migrated information)
Dose descriptor:
LOAEL
Effect level:
400 mg/kg bw/day
Sex:
female
Basis for effect level:
other: First study; 12 weeks, potassium dichromate in mice
Remarks on result:
other: Generation not specified (migrated information)
Dose descriptor:
NOAEL
Effect level:
119 mg/kg bw/day
Sex:
female
Basis for effect level:
other: Second study NOAEL value for maternal toxicity in mice. Test substance is potassium dichromate.
Remarks on result:
other: Generation not specified (migrated information)
Dose descriptor:
NOAEL
Effect level:
63 mg/kg bw/day
Sex:
female
Basis for effect level:
other: Second study. NOAEL level for effect on fertility in mice. The test substance is potassium dichromate.
Remarks on result:
other: Generation not specified (migrated information)
Dose descriptor:
NOAEL
Effect level:
86 mg/kg bw/day
Sex:
female
Basis for effect level:
other: Third study to determine NOAEL for the effect on fertility. The test substance is potassium dichromate.
Remarks on result:
other: Generation not specified (migrated information)

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.