Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
160 mg/kg bw/day
Additional information

The reproductive toxicity of an analog of this substance was evaluated with rats at doses as high as 160 mg/kg/day for up to 52 consecutive days in accordance with OECD 422. No substance-related effects on reproductive performance, gestation length, parturition, reproductive organs, or neurobehavioral parameters were found. Substance-related toxicity was limited to morbundity, adverse clinical signs, and epithelial hyperplasia, hyperkeratosis, and inflammation of the stomach. The NOAEL and NOEL for reproductive fertility and neonatal toxicity was determined to be 160 mg.kg/day. The parental NOAEL for systemic toxicity was 160 mg/kg/day. The parental NOAEL for portal of entry irritation and related secondary effects parental toxicity was 40 mg/kg/day.


Short description of key information:
Reproduction toxicity data are not available for EC 283-392-8, but an OECD 422 study is available for an analogous substance and suitable for read across.

Effects on developmental toxicity

Description of key information
Developmental toxicity data are not available for EC 283-392-8, but an OECD 422 study is available for an analogous substance and suitable for read across. 
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
160 mg/kg bw/day
Additional information

The developmental toxicity of an analog of this substance was evaluated with rats at doses as high as 160 mg/kg/day for up to 52 consecutive days in accordance with OECD 422. No substance-related effects on postnatal survival, bogy weights, body weight gain, or general physical appearance of the pups were found. Substance-related toxicity was limited to morbundity, adverse clinical signs, and epithelial hyperplasia, hyperkeratosis, and inflammation of the stomach. The NOAEL and NOEL for neonatal toxicity was determined to be 160 mg.kg/day. The parental NOAEL for systemic toxicity was 160 mg/kg/day. The parental NOAEL for portal of entry irritation and related secondary effects parental toxicity was 40 mg/kg/day

Justification for classification or non-classification

In accordance to Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008), classification of this substance is not required for reproductive toxicity occurring at maternally toxic doses.