Sodium dichromate

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:

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

Test material information

Constituent 1

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

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)

1

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

2

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.