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Key value for chemical safety assessment

Effects on fertility

Description of key information
No additional reproduction studies are available for this substance.
Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

The oral administration of dicerium tricarbonate, a structure similar to the dineodymium tricarbonate, to rats for 2 weeks before mating, mating (up to 3 weeks for males and females), gestation (females for ~3 weeks) and lactation until post partum day 5 at dose levels up to 1000 mg/kg/day did not result in any toxicologically significant effects related to reproduction performance up to day 4 lactation. The reproductive NOAEL for parental animals or offspring of either sex was considered to be 1000 mg/kg/day. Effects on the stomach, changes in hematology and clinical biochemstry were observed at 450 (males only) and 1000 mg/kg/day (both sexes), thus the NOEL for systemic toxicity was 150 mg/kg/day.

In accordance with section 1 of annex XI of the REACH regulation, a two-generation reproductive toxicity study does not need to be conducted if the study does not appear to be scientifically necessary. A study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently concludes that no classification of the substance as a reproductive toxicant is required.


Short description of key information:
Using read-across data on a similar structure, a GLP-compliant oral gavage combined repeat dose toxicity study with reproduction/developmental toxicity screening test in the rat has been conducted in accordance with OECD Guideline 422 (Klimisch score 1 reduced to 2 because of read-across).
The two-generation reproductive toxicity study has been waived.

Effects on developmental toxicity

Description of key information
Using read-across data on a similar structure, a GLP-compliant oral gavage combined repeat dose toxicity study with reproduction/developmental toxicity screeneing test in the rat has been conducted in accordance with OECD Guideline 422.  No treatment related developmental effects were were observed at doses up to and including 1000 mg/kg/day.
The pre-natal development toxicity study has been waived.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

The oral administration of dicerium tricarbonate, a structure similar to the dineodymium tricarbonate, to rats for 2 weeks before mating, mating (up to 3 weeks for and females), gestation (females for ~3 weeks) and lactation until post partum day 5 at dose levels up to 1000 mg/kg/day did not result in any toxicologically significant effects related to offspring development up to day 4 lactation. Therefore the NOAEL was considered to be 1000 mg/kg/day for developmental toxicity.

In accordance with section 1 of annex XI of the REACH regulation, a pre-natal developmental toxicity study does not need to be conducted if the study does not appear to be scientifically necessary. A study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently concludes that no classification of the substance as a developmental toxicant is required.

Justification for classification or non-classification

With a read-across from a similar structure, there were no treatment related reproductive or offspring effects at dose levels of dicerium tricarbonate, up and including 1000 mg/kg/day in a combined repeat dose toxicity study with reproduction /developomental toxicity screening test in the rat (OECD 422). There is no other data available suggesting that the substance has the potential to be a reproductive or developmental toxin. On this basis the substance is not classified for reproductive or developmental effects.

Additional information