Tin sulfide (Sn2S3)

Endpoint summary

Description of key information

Oral exposure: Tin sulfide showed no effects considered as adverse in a subchronic toxicity study according to OECD guideline 409. The NOAEL was defined at 1000 mg/kg and the NOEL at 300 mg/kg. Based on this information it is considered that also ditin trisulfide reveals after oral application no subchronic toxic effects. The calculated NOAEL for ditin trisulfide is 1106 mg/kg bw/day.  

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

sub-chronic toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Read-Across Justification_SnS and SnS2 to Sn2S3

Reason / purpose for cross-reference:

read-across source

Route of administration:

oral: drinking water

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Description (incidence and severity):

Tin sulfide caused a slight increase in food consumption, associated with slight increases in body weight and serum glucose concentrations in females dosed at 1000 mg/kg. This was not considered as adverse effect.

Food consumption and compound intake (if feeding study):

no effects observed

Description (incidence and severity):

Tin sulfide caused a slight increase in food consumption, associated with slight increases in body weight and serum glucose concentrations in females dosed at 1000 mg/kg. This was not considered as adverse effect.

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

no effects observed

Ophthalmological findings:

no effects observed

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Description (incidence and severity):

Slight dose dependent decreases in serum Na and Cl, varying within physiological range, were observed. Increased serum glucose concentrations in females dosed at 1000 mg/kg was most probably due increased food consumption and not considered as adverse.

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Description (incidence and severity):

No observations indicating neurotoxicity were noted.

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Description (incidence and severity):

No adverse test item and/or treatment related changes

Histopathological findings: neoplastic:

no effects observed

Description (incidence and severity):

No adverse test item and/or treatment related changes

Details on results:

Tin sulfide orally administered to rats for 90 consecutive days caused a slight increase in food consuption, 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. Other lesions found in the treated animals were either of spontaneous character or they were not in direct relation with the administration of tin sulfide.

Dose descriptor:

NOAEL

Effect level:

1 106 other: mg/kg bw/day

Based on:

other: calculated for ditin trisulfide

Sex:

male/female

Basis for effect level:

other: 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 1000mg/ kg and the NOEL at 300 mg/kg.

Critical effects observed:

not specified

RESULTS of DRF Study:

All rats survived till their scheduled necropsy. No signs of toxicity were recorded in all administered animals of all tested groups during the observation period. Variability observed in body weight and food consumption were not treatment related and both recorded parameters were not influenced with the test item administration. No treatment-related changes were found in the red blood cells, white blood cells and coagulation parameters. The decrease in APTT values in dose group D1 was probably no treatment related. No treatment related changes were observed during the study in the clinical chemistry and urinalysis parameters monitored. No gross pathology findings were found during necropsy of the animals. In conclusion, 14 days oral administration of tin sulfide at doses of 500 and 1000 mg/kg body weight/day in rats was safe and well tolerated. Based on the obtained results it was proposed to design the 90-day Subchronic Toxicity Study with doses of 100, 300 and 1000 mg/kg body weight/day.

Conclusions:

Read-across substance tin sulfide showed no effects considered as adverse in a subchronic toxicity study according to OECD guideline 409. The NOAEL was defined at 1000 mg/kg and the NOEL at 300 mg/kg.
Based on this information it is considered that also ditin trisulfide reveals after oral application no subchronic toxic effects. The calculated NOAEL for ditin trisulfide is 1106 mg/kg bw/day.

Executive summary:

A 90-day study according to OECD guideline 409 with read-across substance tin sulfide was performed in rats to provide information on the possible health hazards likely to arise from repeated oral exposure over a prolonged period of time covering post-weaning maturation and growth well into adulthood. Three treated groups were administered with doses of 100 mg and 300mg/kg and 1000 mg/kg bw per day. Tin sulfide caused 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 indicate of a toxic effect. Under the test conditions used, 90-day administration of the test item to rats was safe and well tolerated up to the dose of 1000 mg/kg bw/day. The NOAEL was defined at 1000mg/kg and the NOEL at 300 mg/kg.

Based on this information it is considered that also ditin trisulfide reveals after oral application no subchronic toxic effects. The calculated NOAEL for ditin trisulfide is 1106 mg/kg bw/day.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 106 mg/kg bw/day

Study duration:

subchronic

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

A 90-day study according to OECD guideline 409 with tin sulfide was performed in rats to provide information on the possible health hazards likely to arise from repeated oral exposure over a prolonged period of time covering post-weaning maturation and growth well into adulthood. Three treated groups were administered with doses of 100 mg and 300mg/kg and 1000 mg/kg bw/day. Tin sulfide caused 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 indicate of a toxic effect.Under the test conditions used, 90-day administration of the test item 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 bw/day and the NOEL at 300 mg/kg bw/day.

Based on this information it is considered that also ditin trisulfide reveals after oral application no subchronic toxic effects. The calculated NOAEL for ditin trisulfide is 1106 mg/kg bw/day.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:

GLP and guideline compliant study on a structural analogous read-across substance

Justification for classification or non-classification

According to the results of a subchronic repeated oral dose toxicity study on tin sulfide, no classification and labelling is required for ditin trisulfide according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.