Registration Dossier

Administrative data

Description of key information

Regardless of the high Cr3+ doses, chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination.

Citric acid and associated salts are found in many foods and are formed in cells as a metabolite from glycolysis. There is no toxicity theshold for repeated exposure in humans, although acute toxic effects have been reported in animals.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 200 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Confirmed in CICAD Review document (UN Concise International Chemical Assessment Document 76 )

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEC
44 000 mg/m³
Study duration:
subchronic
Species:
rat
Quality of whole database:
Confirmed in CICAD Review document (UN Concise International Chemical Assessment Document 76 )

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
44 000 mg/m³
Study duration:
subchronic
Species:
rat
Quality of whole database:
Confirmed in CICAD Review document (UN Concise International Chemical Assessment Document 76 )

Mode of Action Analysis / Human Relevance Framework

Additional information

Justification for classification or non-classification