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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
sub-chronic toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
Justification for type of information:
See Repeated dose toxicity: oral / Key DRF and 90-Day Subchronic Oral Toxicity/Repeated dose toxicity: oral.BioTest.2010 RA target / Ditin trisulfide / Tin(II,IV)-sulfide /
12067-23-1
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
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.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion