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Description of key information

A 90- day repeated dose toxicity study in rats daily dosed with Tin sulfide at doses of 100, 300 and

1000 mg/kg bw per day resulted in a slight increase in food consumption, associated with slight increases

in body weight and serum glucose concentrations in females dosed at 1000 mg/kg, as well as slight

decreases in serum Na and Cl. Except for the above mentioned changes, Tin sulfide did not cause any

other changes. Therefore Tin sulfide was considered safe and well tolerated up to the dose of

1000 mg/kg bw/day. The NOAEL was defined at 1000 mg/kg and the NOEL at 300 mg/kg.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
High (Klimisch 1)

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

A key 90- day repeated dose toxicity study in rats daily dosed with Tin sulfide was available (Slais, 2010). Four groups of rats (male/female Wistar rats) were daily administered with the test item suspension in 0.5% Carboxymethylcellulose (CMC) orally by gavage for 90 days.Three treated groups were administered with doses of 100, 300 and 1000 mg/kg bw per day. Dosing resulted in a slight increase in food consumption, associated with slight increases in body weight and serum glucose concentrations in females dosed at 1000 mg/kg. These were however not considered as adverse effects. Slight dose dependent decreases in serum Na and Cl, varying within physiological range, were observed. Except for the above mentioned changes, Tin sulfide did not cause any negative effect on body weight, food consumption, ophthalmoscopy, hematology and clinical chemistry parameters and organ weights. Tin sulfide further did not cause any organ weight changes nor gross or histopathological changes in the liver, kidneys, gastrointestinal tract or other organs of survived animals indicative of a toxic effect. Under the test conditions used, 90 - day administration of the test item Tin sulfide to rats was safe and well tolerated up to the dose of 1000 mg/kg bw/day. The NOAEL was defined at 1000 mg/kg and the NOEL at 300 mg/kg.

 

Based on the similar structural and physicochemical properties of Tin disulfide (target chemical) and tin sulfide (source chemical), as well as the comparable and low toxicological profiles for acute toxicity, local tolerance and genetic toxicity, the results of the 90-day repeated dose toxicity study with Tin sulfide are considered valid as read-across to Tin disulfide. Therefore no new study has been conducted and current study is considered key study for repeated dose toxicity of Tin disulfide. Further argumentation is provided in a separate document on read-across argumentation under Section 13.

 

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint: Key study with read across substance. Argumentation on the adequacy of read across between target and source chemical has been documented in a separate document (see Section 13).

Justification for classification or non-classification

No classification and labelling is needed for repeated dose toxicity for Tin disulfide according to EU labelling regulations Commission Directive 93/21/EEC and CLP regulation (No. 1272/2008 of 16 December 2008).