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Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat

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

Justification for classification or non-classification

No intrinsic data is available on the reaction mass itself.

The classification is based on the data on the both constituents.

* Dicerium trisulphide:

28d-NOAEL (Rat, male and female) = 150 mg/kg bw/day

Based on the experimental conditions of this study, it is concluded that the oral administration of Dicerium trisulphide at a dose of 1000 mg/kg/day is associated with local irritant changes in the stomach and duo denum and with microcytic anemia. All changes showed complete or almost complete reversibility by the end of the 2-week recovery period.

Although some similar, but slight, localized microscopic changes were seen in an isolated animal dosed with 150 mg/kg/day, this dose can be considered to represent a No Observed Adverse Effect Level (NOAEL) for local effects.

* Dilanthanum trisulphide

28d-NOAEL (Rat, male and female) = 150 mg/kg bw/day

The repeated oral administration of Lanthanum sulphide at a dosage of 150 mg/kg/day for four weeks was well tolerated with no evidence of severe organ dysfunction. No significant changes were seen at the dose level of 15 mg/kg/day and this is considered to be the a No-Observed-Effect Level (NOEL) in this study.

* Reaction mass

According to the studies available on Dicerium trisulphide and Dilanthanum trisulphide, these test substances are not classified for repeated dose toxicity by oral route. Therefore, Reaction mass of dicerium trisulphide and lanthanum trisulphide is not classified for repeated dose toxicity by oral route.

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