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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Description of key information

The bioavailability of orally ingested Cr(III) is so low (1%) that a significant passage into breast milk can be excluded. In addition, there is no potential for accumulation in tissues that could later serve as a source for Cr(III) in breast milk.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

There are two subchronic feeding studies in rats and mice available performed with the source substance Cr(III) picolinate (Rhodes et al., 2005) which also investigated potential effects on reproductive organs, sperm parameters or oestrus cycle. Even at daily doses greatly exceeding the limit dose of 1000 mg/kg/day, none of these parameters were affected. It can therefore be safely predicted that basic Cr(III) acetate will not affect fertility parameters.

The REACh regulation states that testing into the reproductive toxicity of a substance are not required if the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure and there is no or no significant human exposure.

Most, if not all, prerequisites for a compete waiving of reproductive toxicity testing requirements are met for chromium triacetate. The acute and repeated-dose toxicity studies reflect the fact that Cr(III) is poorly absorbed from the gastrointestinal tract (1%). No systemic effects were seen in any animal study.

Short description of key information:

Subchronic oral studies in the rat showed no effects on reproductive organs, sperm parameters or oestrus cycle parameters. Cr(III) is poorly absorbed and no systemic effects are expected at all.

Justification for selection of Effect on fertility via oral route:

Hazard assessment is conducted by means of read-across from a structural analogue/surrogate. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall assessment of quality, duration and dose descriptor level (refer to the endpoint discussion for further details).

Effects on developmental toxicity

Description of key information

Cr(III) did not cause developmental effects at doses equivalent to 155 mg/kg bw/day basic Cr(III) acetate monohydrate

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

A developmental toxicity study in mice was conducted with the source substances Cr(III) picolinate and CrCl3. While Cr(III) picolinate caused an increased incidence in bifurcated cervical arches, this effect was not observed with CrCl3, although the administered chromium dose was higher in the CrCl3 group compared to the Cr picolinate group (39 vs. 25 mg Cr/kg bw/day). Picolinic acid alone caused a doubling of the incidence in bifurcated cervical arches when compared to controls, but this trend did not prove to be statistically significant. It therefore appears as if the ligand, picolinate, contributes to the occurrence of the skeletal variation. The absence of these effects in the CrCl3 group suggests that Cr(III) per se is not detrimental to prenatal development. The maternal and developmental NOAEL is ≥ 39 mg Cr/kg bw/day, equivalent to 155 mg/kg bw/day basic Cr(III) acetate monohydrate.

Justification for selection of Effect on developmental toxicity: via oral route:

Hazard assessment is conducted by means of read-across from a structural analogue/surrogate.

Justification for classification or non-classification

The available data on reproductive toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and is therefore conclusive but not sufficient for classification.

Additional information