Registration Dossier

Administrative data

Description of key information

In an oral OECD 422 study (Gerspach et al., 2005) in which rats were dosed by gavage with 3-(triethoxysilyl)propiononitrile at doses up to 1000 mg/kg bw/day, increased organ weights (kidneys, spleen, heart and liver in  males; kidneys and spleen in toxicity group females), slight reduction in  red cell count (not statistically significant), hemoglobin concentration  and hematocrit in males and toxicity group females and histopathological  changes in kidneys (chronic tubular lesions of minimal to moderate severity with minimal to slight hyperplasia of the renal pelvis epithelium [related to tubular damage], and renal  pyelonephritis) were noted in males and toxicity group females dosed at  1000 mg/kg bw/day.  Administration of 500 mg/kg bw/day resulted in increased organ weights  (kidneys, heart and liver in males only) and histopathological changes in kidneys including chronic tubular lesions with minimal to slight hyperplasia of the renal  pelvis epithelium (isolated) and renal pyelonephritis (males and toxicity group  females) and spleen including extramedullary hematopoiesis (males only).  

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
100 mg/kg bw/day

Additional information

The key study for repeated dose toxicity is the only study available for this endpoint. It is a reliable OECD 422 Combined Repeat Dose Toxicity and Screening Study for Reproductive and Developmental Toxicity, carried out in compliance with GLP.

Justification for classification or non-classification

The available data suggests that CNE should not be classified for specific target organ toxicity following repeated oral exposure because there was no evidence of significant toxic effects in a 28-day study.