Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

In a reproduction / developmental toxicity screening test according to OECD guidline 421 performed under GLP conditions, the histopathological evaluation of male and female reproductive organs did not reveal any histopathological lesions considered to be treatment related.

Based on these results, the no observed adverse effect level (NOAEL) of the test item is considered to be 1000 mg/kg bodyweight for reproduction / developmental toxicity screening in males and females.


Short description of key information:
Reproduction / developmental toxicity screening test (GLP, OECD 421): NOAEL 1000 mg/kg bw
As a consequence, no distinct chemical safety assessment, including exposure determination and risk characterisation, has to be performed in accordance with article 14(4) of the REACH regulation.

Effects on developmental toxicity

Description of key information
Reproduction / developmental toxicity screening test (GLP, OECD 421): NOAEL 1000 mg/kg bw
As a consequence, no distinct chemical safety assessment, including exposure determination and risk characterisation, has to be performed in accordance with article 14(4) of the REACH regulation.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 ng/kg bw/day
Additional information

In a reproduction / developmental toxicity screening test according to OECD guidline 421 performed under GLP conditions, the histopathological evaluation of male and female reproductive organs did not reveal any histopathological lesions considered to be treatment related.

Based on these results, the no observed adverse effect level (NOAEL) of the test item is considered to be 1000 mg/kg bodyweight for reproduction / developmental toxicity screening in males and females.

Justification for classification or non-classification

Since neither any classification criteria according to GHS/CLP (Regulation (EC) No. 1272/2008) nor any criteria according to DSD (Directive 67/548/EEC) are fulfilled, the substance is not classified for toxicity to reproduction.