Tin sulphide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-04-12 to 2010-04-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

, adopted 17 December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tin sulphide

EC Number:

215-248-7

EC Name:

Tin sulphide

Cas Number:

1314-95-0

Molecular formula:

SSn

IUPAC Name:

stannanethione

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals were received from Ace Animals, Boyertown, PA on 04/06/10. Following an acclimation period of
at least five days, three healthy male and three healthy, non-pregnant and nulliparous female Sprague
Dawley rats were assigned to treatment groups without conscious bias.
The animals were born the weeks of 02/07/10 & 02/15/10. The pretest body weight range was
201 - 225 grams for males and 169- 189 grams for females. The weight variation of the animals used did
not exceed ± 20% of the mean weight of the previously dosed animals within a sex.
The animals were identified by cage notation and indelible body marks, and housed in suspended wire
cages, 5/sex/cage prior to dosing and 3/sex/cage following dosing. Paper bedding was placed beneath
the cages and changed at least three times/week. Fresh PMI Rat Chow (Diet #5012) was freely available
except for 16-20 hours prior to dosing. Water was available ad libitum. The animal room, reserved
exclusively for rats on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was
kept clean and vermin free.

Administration / exposure

Route of administration:

oral: feed

Vehicle:

CMC (carboxymethyl cellulose)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Dosing
The test article was mixed with 2% methyl cellulose to make dosing by gavage possible. The dose was
based on the dry weight of the test article. A single dose was administered orally by syringe and dosing
needle at a dose level of 2000 mg/kg to three male and three female rats.
Type and Frequency of Observations
In Vivo- Animals were observed 0.5, 1, 2, 3 and 4 hours postdose and once daily for 14 days for mortality,
toxicity and pharmacological effects. Body weights were recorded immediately pretest, weekly, and at
termination.
Post Mortem- All animals were humanely sacrificed using C02 and were examined for gross pathology
following study termination.
Analysis of Data
The Acute Toxic Category is assigned as follows:
Category 1 = LD50 (>0 mg/kg <5 mg/kg) Category 4 = LD50 (>300 mg/kg <2000 mg/kg)
Category 2 = LD50 (>5 mg/kg <50 mg/kg) Category 5 = LD50 (>2000 mg/kg <5000 mg/kg)
Category 3= LD50 (>50 mg/kg <300 mg/kg) Category 5 or Unclassified = LD50
(>2000 mg/kg <5000 mg/kg with 0 Mortality)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the 2000 mg/kg oral dose.

Clinical signs:

other: All animals survived the 2000 mg/kg oral dose, all body weights were normal for both sexes. There were no abnormal physical signs noted during the observation period. Necropsy results were normal.

Gross pathology:

All animals survived the 2000 mg/kg oral dose, all body weights were normal for both sexes. There were no abnormal physical signs noted during the observation period. Necropsy results were normal.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

CLP: Not classified

Conclusions:

The Acute Toxic Class Determination according to OECD guideline 423 revealed an LD50 is > 2000 mg/kg bw for tin sulfide in rats.

Executive summary:

The Acute Toxic Class Determination according to OECD guideline 423 was used to determine the oral toxicity of tin sulfide in rats.

All animals survived the 2000 mg/kg oral dose, all body weights were normal for both sexes. There were no abnormal physical signs noted during the observation period. Necropsy results were normal.