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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Toxic effect type:
concentration-driven

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
20 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Organ:
kidney
liver

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data on toxicity after repested exposure 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 then tested in a key 90-day oral gavage toxicity study at dose levels 20, 60, 180 mg/kg bw/day (Valásková, 2007a). There was no mortality nor any significant change in functional (behavioural) and ophthalmological observations. The test substance caused reversible decrease in body weight increments in both sexes (more marked in males) in all dose levels. It was connected with reversible decrease of food consumption and food conversion in both sexes. Reversible changes of health status (piloerection) and clinical changes immediately after application (excited behavior) were recorded in both sexes of the highest dose level. Haematological examination showed an effect on leukocyte differential count in both sexes without dependence on dose level. Portion of lymphocytes was increased and portion of monocytes and granulocytes was decreased. In females of the highest dose level also the increase of number of leucocytes and platelets was observed. During biochemical examination of blood the statistically significant changes were detected at the highest dose level: increased value of urea in both sexes, increased value of chloride ions in males, decreased value of AST, creatinine and potassium ions in males, increased value of bilirubin and ALT in females and decreased value of creatinine and sodium ions in females. Increase of bilirubin was irreversible. Statistically significantly decreased volume of urine was detected in males especially at highest dose level. It was connected with increase of specific gravity of urine. Increased value of pH of urine was recorded in satellite males of the dose level 180 mg/kg bw/day and females of the dose levels 60 and 180 mg/kg bw/day. Decreased volume of urine accompanied by higher specific gravity of urine occurred also in females of the dose level 180 mg/kg bw/day. Statistically significant changes in liver and kidney weight at the (middle and) the highest dose in males and females, which were not or only partly reversible after the recovery phase. In males, this was accompanied by change of colour, however only after the dosing phase and not after the recovery phase.

The most important histological affections were diagnosed in kidneys of males of the (mid and) highest dose level –hyaline droplets in renal tubules and mesangial cell proliferation in renal glomeruli. In the same treated group also the increase of incidence of histiocytosis of lymph nodes and involution of thymus was registered. In females the increased incidence of hydrometra (uterus) was found in all treated groups irrespective of dose level. The LOAEL (Lowest Observed Adverse Effect Level) for males and females was established as 60 mg/kg bw/day. The NOAEL (No Observed Adverse Effect Level) for males and females is 20 mg/kg bw/day.

In conclusion, liver and kidney were retained as target organs due to relevant changes at the highest dose level of 180 mg/kg bw. The other changes at the same dose level and changes at 60 mg/kg were not considered adverse or significant, therefore no changes need to be classified.

Justification for classification or non-classification

Based on the data on the read-across substance there is no need to classify the substance in accordance with the criteria of CLP Regulation 1272/2008.