Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

The results presented in various publications (including UN CICAD and European Food Scientific Committe on Food are used) suggest that trivalent chromium has no effect on fertility at tolerated levels of exposure.

The results of work with high doses showed mixed results with some parameters such as viablity of implants possibly reduced (sample sizes too small for reliable statistics) and reduced mating performance that may be in relation to reduced body weights - ie secondary effects to other adverse parental toxicity.

Citric acid and salts are consumed in large quantities as natural food.

Ultimately, it needs to be realised that Cr3+ is an essential element in diet and occurs in food and natural water. It is readily excreted and is non-accumulative.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
25 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
30 mg/m³
Study duration:
subchronic
Species:
rat
Quality of whole database:
Expressed as Cr3+

Effects on developmental toxicity

Description of key information

An increase in the average number of total resorbed or dead foeti was observed in the treated group as compared to controls; however, the increase was not statistically significant.

No significant effect of exposure was seen on gross or skeletal malformations or skeletal variations. Foeti sired by exposed males weighed more than those of unexposed males but this finding was considered a statistical anomaly.

Note that both chromium III and oxalic acid salts are found in food. Chromium III is an essential element and oxalic acid is a product of metabolism that is typically excreted.

In view of high concentrations in the diet and in living tissues, the substance is not considered to be toxic for reproduction.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
25 mg/kg bw/day
Study duration:
subacute
Species:
mouse
Additional information

No signs of maternal toxicity were observed.

No decrease in foetal weight or significantly increased incidence of skeletal defects was observed compared to the controls

Justification for classification or non-classification

Extract from Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Trivalent Chromium (expressed in 4 April 2003)

Chromium (III) chloride dissolved in tap water was given to sexually mature male and female Swiss mice (day 50 of age). Males received water with 1000 or 5000 mg/L chromium chloride and females with 2000 or 5000 mg/L ad libitum for 12 weeks. Controls were given tap water, only. Treated animals consumed less water per day than controls did. Chromium chloride reduced fertility and seminal vesicle weights significantly. Body weights were reduced in males but not in females. Testes and ovarian weights were increased whereas uterine weights were significantly reduced. The number of resorptions and dead foetuses was increased in females impregnated by males exposed to the trivalent compound and the number of resorptions in exposed females as well (Elbetieha and Al-Hamood, 1997). Unfortunately, the authors did not report the actual quantitative exposure to chromium chloride but EGVM (2002b) estimated from the given data oral doses for trivalent chromium of approximately 500 or 1250 mg/kg bw/day for females and 250 or 1250 mg/kg bw/day for males.

The fertility of male Sprague Dawley rats exposed to chromium (III) chloride in drinking water at a concentration of 1000 mg/L for 12 weeks, which is equivalent to about 50 mg CrCl3/kg body weight or about 16,5 mg trivalent chromium/kg body weight, was unaffected but significant reductions in the weight of testes and seminal vesicles were observed (Bataineh et al., 1997).

There are no reports of developmental toxicity studies on chromium (III) compounds given orally


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