Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

The effects of repeated administration of silicon nitride on parent animales and their reproductive performance were evaluated in Crj:CD (SD) IGS rats by administering the test substance at 0, 100, 300 and 1000 mg/kg/day to 12 male and 12 female rats per group. The test substance was administered orally to males for 35 days, including 14 days prior to mating and the subsequent mating period, and to females from 14 days prior to mating until day 3 of lactation through the mating and gestation periods. No mortality or changes in general signs and symtoms, body weight, feed consumption, necropsy findings, organ weights or histopathological findings attributable to the test substance were noted in males or in females in any group. No effects related to administration of the test substance were observed in the estrous cycle, number of corpora lutea or implantations, copulation index or gestation index, or the number of days needed for copulation. On examination at delivery and during the lactation period, no effects related to administration of the test substance were observed on the gestation period, gestation index, number of offspring per litter and birth index. Therefore it was concluded that a NOAEL for fertility was 1000 mg/kg/day.


Short description of key information:
NOAEL for parents in a reproductive toxicity study was 1000 mg/kg/day.

Justification for selection of Effect on fertility via oral route:
Study was carried out to a detailed method and was conducted as part of an OECD program to inspect the safety of existing chemical substances.

Effects on developmental toxicity

Description of key information
NOAEL for developmental toxicity to offspring was 1000 mg/kg/day.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
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

The effects of repeated administration of silicone nitride on the development and growth of offspring were evaluated in Crj:CD (SD) IGS rats by administering the test substance at 0, 100, 300 and 1000 mg/kg/day to 12 male and 12 female rats per group. The test substance was administered orally to males for 35 days, including 14 days prior to mating and the subsequent mating period, and to females from 14 days prior to mating until day 3 of lactation through the mating and gestation periods. No effects related to administration of the test substance were observed on number of live newborns, stillbirth index, sex ratio or body weights of live newborns on Day 0 or 4 of lactation, or viability index on Day 4 of lactation. Newborns showed no external abnormalities in any group. Therefore it was concluded that a NOAEL for developmental toxicity was 1000 mg/kg/day.

Justification for classification or non-classification

The NOAEL for reproductive and developmental toxicity was 1000 mg/kg/day. Therefore Silicon Nitride is not classified for reproductive or developmental toxicity.