Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Animals were dosed at 100, 500 and 1000 mg/kg/day under OECD Guideline 421. Group mean body weight gains and food consumption in the males throughout the study, and for females during gestation and lactation were similar to control. Mating performance, fertility, duration of gestation, litter size and survival, and litter and pup weights did not indicate any obvious effect of treatment at any of the dose levels tested. Based on the results of this study, the no observed effect level (NOEL) for adults and for reproductive parameters was considered to be 1000 mg/kg/day.

 

Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered members of a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across and/or trend analysis between category members.

Please see IUCLID section 13 for the category justification and a matrix of data on toxicity to reproduction for members of the Perfluorinated Organic Chemicals C5-C18 category.


Short description of key information:
A reproductive/developmental test has not been conducted on perfluoro-N-methylmorpholine (FC-3284). A reproductive/developmental screening test (OECD 421) was conducted on Fluoroinert Category member perfluoroisopropylmorpholine (FC-770). Perfluoroisopropylmorpholine was not toxic to reproduction or developmental effects via oral gavage when tested at concentrations up to 1000 mg/kg/day.

Effects on developmental toxicity

Description of key information
A reproductive/developmental test has not been conducted on perfluoro-N-methylmorpholine (FC-3284).  A reproductive/developmental screening test (OECD 421) was conducted on Fluoroinert Category member perfluoroisopropylmorpholine (FC-770). Perfluoroisopropylmorpholine was not toxic to reproduction or developmental effects via oral gavage when tested at concentrations up to 1000 mg/kg/day.
Additional information

Animals were dosed at 100, 500 and 1000 mg/kg/day under OECD Guideline 421.Group mean body weight gains and food consumption in the males throughout the study, and for females during gestation and lactation were similar to control. Mating performance, fertility, duration of gestation, litter size and survival, and litter and pup weights did not indicate any obvious effect of treatment at any of the dose levels tested. Based on the results of this study, the no observed effect level (NOEL) for adults and for reproductive parameters was considered to be 1000 mg/kg/day. Please see IUCLID section 13 for the category justification and a matrix of data on toxicity to reproduction for members of the Perfluorinated Organic Chemicals C5-C18 category.

 

Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered members of a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across and/or trend analysis between category members.

Justification for classification or non-classification

The results of these tests do not meet the requirement to classify perfluoro-N-methylmorpholine as Toxic for Reproduction.