Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Klimish: 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

Adult animals dosed with COAG-122 at doses of up to 1000 mg/kg/day showed minimal evidence of adverse response. During the first week of treatment effects were seen on male bodyweight at the high dose level but the animals quickly recovered to show normal growth patterns through the rest of the study. Reversible effects in the first week are not considered to equate to an "adverse" response.


Short description of key information:
It was concluded that the No-Observed-Adverse-Effect-Level (NOAEL) for COAG-122 was in excess of 1000 mg/kg/day (the limit dose) for reproductive performance and offspring growth and survival in the CD rat following oral gavage administration in a standard screening test.

Effects on developmental toxicity

Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Additional information