Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

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

The reproductive toxicity of this substance was evaluated with rats at doses as high as 200 mg/kg/day in accordance with OECD Guideline 421. Adverse effects on reproduction were observed only at doses that caused maternal toxicity. Treatment-related mortality and clinical signs were noted in the parents at dose levels of 100 and 200 mg/kg/day by mortality and clinical signs. Treatments-related inhibition of body weight gain in males and signs of gastric irritation also was observed at the 200 mg/kg/day dose level. No parental toxicity was found at the 30 mg/kg/day dose level. Slightly reduced fertility indices were observed at the 200 mg/kg/day dose level. Reproductive performance (fertility, mating, days between pairing and coitus, gestation and parturition) was unaffected by treatment at the 30 and 100 mg/kg/day dose levels. Based on the results of this study, a dose level of 30 mg/kg/day was considered to be the NOAEL (no observable adverse effect level) for parental and neonatal toxicity.


Short description of key information:
The oral administration of EC 224-235-5 to rats by gavage at doses as high as 200 mg/kg/day in the parental generation. Treatment-related mortality and clinical signs were noted in the parents at dose levels of 100 and 200 mg/kg/day by mortality and clinical signs. Reproductive performance (fertility, mating, days between pairing and coitus, gestation and parturition) was unaffected by treatment at the 30 and 100 mg/kg/day dose levels. Based on the results of this study, a dose level of 30 mg/kg/day was considered to be the NOAEL for parental and neonatal toxicity.

Effects on developmental toxicity

Description of key information
The oral administration of EC 224-235-5 to rats by gavage at doses as high as 200 mg/kg/day in the parental generation. Treatment-related mortality and clinical signs were noted in the parents at dose levels of 100 and 200 mg/kg/day by mortality and clinical signs. No parental toxicity was found at the 30 mg/kg/day dose level. Neonatal mortality in the F1 generation was observed at the 100 and 200 mg/kg/day dose levels. Neonatal clinical signs of toxicity also were noted at the 200 mg/kg/day dose level as evidenced by clinical signs. No neonatal toxicity was observed at a dose level of 30 mg/kg/day. Based on the results of this study, a dose level of 30 mg/kg/day was considered to be the NOAEL for neonatal toxicity. 
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
30 mg/kg bw/day
Additional information

The potential of this substance to affect development was evaluated with rats at doses as high as 200 mg/kg/day in accordance with OECD Guideline 421. Adverse effects on development were observed only at doses that caused maternal toxicity. Treatment-related mortality and clinical signs were noted in the parents at dose levels of 100 and 200 mg/kg/day by mortality and clinical signs. Treatments-related inhibition of body weight gain in males and signs of gastric irritation also was observed at the 200 mg/kg/day dose level. No parental toxicity was found at the 30 mg/kg/day dose level. Neonatal mortality in the F1 generation was observed at the 100 and 200 mg/kg/day dose levels. Neonatal clinical signs of toxicity also were noted at the 200 mg/kg/day dose level as evidenced by clinical signs. No neonatal toxicity was observed at a dose level of 30 mg/kg/day. Based on the results of this study, a dose level of 30 mg/kg/day was considered to be the NOAEL (no observable adverse effect level) for parental and neonatal toxicity.

 

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.

Additional information