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
200 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The study is a GLP compliant and has a Klimisch score 2 (read-across from an endpoint with Klimisch score 1).
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Key study: Read-across approach from experimental data on the analogue substance MPKO:

The systemic toxic potential and effects on reproduction of the analogue MPKO were assessed in rats following oral administration for at least five weeks in accordance with OECD Guideline 422 (GLP study). Based on the read-across approach from the analogue substance MPKO, the hydrolysis product of OS9600 (NOEL = 150 mg/kg bw/day since no adverse effects observed on the reproductive screening parameters at the highest dose level), the NOEL for OS9600 was determined to be 200 mg/kg bw/day for reproductive toxicity in rats.


Short description of key information:
Key study: Based on the read-across approach from the analogue substance MPKO, The NOEL for OS9600 was determined to be 200 mg/kg bw/day since no effects were observed on reprotox parameters at the highest dose tested.

Justification for selection of Effect on fertility via oral route:
Only one study available.

Effects on developmental toxicity

Description of key information
Key study: Based on the read-across approach from the analogue substance MPKO, the NOEL for OS9600 was determined to be 200 mg/kg bw/day since no effects were observed on developmental parameters at the highest dose tested.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The study is a GLP compliant and has a Klimisch score 2 (read-across from an endpoint with Klimisch score 1).
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

Key study: Read-across approach from experimental data on the analogue substance MPKO:

The systemic toxic potential and effects on reproduction of the analogue MPKO were assessed in rats following oral administration for at least five weeks in accordance with OECD Guideline 422 (GLP study). Based on the read-across approach from the analogue substance MPKO, the hydrolysis product of OS2600 (NOEL = 150 mg/kg bw/day since no adverse effects observed on the developmental screening parameters at the highest dose level), the NOEL for OS9600 was determined to be 200 mg/kg bw/day for developmental toxicity in rats


Justification for selection of Effect on developmental toxicity: via oral route:
Only one study available.

Justification for classification or non-classification

Taking into account the results obtained in the combined repeat dose and reproductive/developmental toxicity screening study, the substance OS9600 is not classified in accordance with CLP Regulation (EC) no. 1272/2008 since no adverse effects were observed on reproductive and/or developmental parameters both in P and F1 generations.