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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxic effect type:
concentration-driven

Effects on fertility

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because a pre-natal developmental toxicity study is available
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
10 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
10 mg/kg bw/day
Study duration:
subchronic
Species:
rabbit
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

No data on reproduction toxicity is available for Monalazone Disodium. Read-across data is used to fulfill information requirement for this endpoint. Read-across justification is attached in the CSR Appendix I.

Chloramine B trihydrate was administered to female rabbits at dose levels of 10, 30 and 90 mg/kg bw/day orally, by gavage from the 6th to 28th day of pregnancy (Hansen, 2011; key study). In addition, a restricted feeding control was employed consisting of untreated dams which were offered the food amount consumed by the high dose dams. Under the present test conditions, the no-observed-effect level (NOEL) was 10 mg/kg bw/day for the dams. Transient slight or moderate reductions were noted for the body weight and food intake of the dams treated with 30 mg /kg bw/day. Distinct reductions of body weight and food consumption, especially during the first days of treatment, were noted at 90 mg/kg bw/day. Similar reductions of body weight and food intake were noted in the untreated dams with restricted feeding. The no-observed-effect level (NOEL) for the fetal organism also was 10 mg/kg bw /day. A dose level of 30 mg/ kg bw /day resulted in increased incidences of total skeletal retardations, in particular sternebra(e) not ossified. The severely materno-toxic dose level of 90 mg/kg bw /day resulted in developmental retardations in the form of reduced placental and fetal body weights compared to the control. Skeletal examination (according to DAWSON) revealed increased fetal incidences for variations of the sternum (fusions) and total skeletal variations as well as retardations of the sternum and lumbar vertebral bodies (incomplete or missing ossification) and total skeletal retardations. No test item related malformations were noted during external, internal or skeletal examination (according to DAWSON) of the fetuses or soft tissue examination of the fetal heads (according to WILSON) at any tested dose level, not even at materno-toxic dose levels. No embryotoxic changes were noted for the restricted feeding group. In conclusion, the test item possessed no teratogenic properties. Chloramine B trihydrate revealed slight embryotoxicity at materno-toxic dose levels (30 or 90 mg/ kg bw/day).

Justification for classification or non-classification

Monalazone Disodium does not need to be classified for reproductive and developmental toxicity according to the CLP regulation (No. 1272/2008).

Additional information