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EC number: 215-252-9 | CAS number: 1315-01-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to standard methods and GLP and is consdered adequate, reliable and relevant for classification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Tin disulphide
- EC Number:
- 215-252-9
- EC Name:
- Tin disulphide
- Cas Number:
- 1315-01-1
- Molecular formula:
- S2Sn
- IUPAC Name:
- tin disulphide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar- HsdCpd: WU
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house random bred ( Toxicology, Department of Safety Assessment, Advinus Therapeutics Limited, Bangalore, India)
- Age at study initiation: 8-12 weeks
- Weight at study initiation: At the selection of animals for each treatment step, the weight variation of animals will be minimal and will not exceed ± 20% of the mean body weight of any previously dosed animals.
- Fasting period before study: 16-18 hours before administration ( access to water will not be interrupted)
- Housing: individually in standard polysulfone cages (Size: approximately L 425 x B 266 x H 175 mm), with stainless steel top grill having facilities for pelletted food and drinking water
- Diet (e.g. ad libitum): Teklad Certified (2014C) Global 14% Protein Rodent Maintenance Diet-Pellet (Certified) manufactured by Harlan Laboratories B.V. Maasheseweg 87c PO Box 553, 5800, AN Venray, The Netherlands, ad libitum
- Water (e.g. ad libitum): deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd., Mumbai 400 001, India in polycarbonate bottles with stainless steel sipper tubes
- Acclimation period: cannot be fixed since the procedure is a step by step method, at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Milli-Q water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: stable suspension up to 24 hour
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- The main test consists of a single ordered dose progression in which animals are dosed, one at a time, at a minimum of 48-hour intervals. The first animal received a limit dose of 2000 mg/kg body weight, the animal survived, the dosing was continued with additional four animals sequentially with the same dose each animal was observed carefully for up to 48 hours before making a decision on whether and how much to dose the next animal. This decision is based on the 48 hour survival pattern of all the animals up to the time. A combination of stopping criteria is used to keep the number of animals low while adjusting the dosing pattern to reduce the effect of a poor starting value or a low slope. Dosing is stopped when one of these criterions is satisfied, at which time an estimate of the LD50 and the confidence intervals are calculated for the test based on the status of all the animals at termination.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: The animals were observed five times on test day 1 (day of administration) i.e., at 30 minutes, 1, 2, 3 and 4 hours after dose administration and once daily during days 2 – 15. Individual body weights of animals were recorded on test day 1 (Pre-administration), day 8 (7 days post administration) and day 15 (14 days post administration).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- The AOT425 Stat Programme was downloaded from Web Site http://www.epa.gov/oppfead1/international/harmonization.html and implemented in the test facility’s system for LD50 calculation.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- As there were no clinical signs of toxicity and no mortality in all five rats tested, the test was terminated.
- Clinical signs:
- other: There were no clinical signs of toxicity in any of the animals.
- Gross pathology:
- There were no abnormalities detected at necropsy.
Any other information on results incl. tables
Table 1. Body weight, Body weight change and Pre-terminal deaths
Step and Dose (mg/kg Body weight) |
Rat No. |
Sex |
Body weight (g) |
||||
Initial (Day 1)
|
Day 8 |
Weight change (Day 8 – Initial) |
Day 15 |
Weight change (Day 15 – Initial) |
|||
Step 1 (2000) |
Rm751 |
F |
194.8 |
204.6 |
9.8 |
210.9 |
16.1 |
Step 2 (2000) |
Rm752 |
F |
192.6 |
212.5 |
19.9 |
215.6 |
23 |
Step 3 (2000) |
Rm753 |
F |
194.8 |
214.1 |
19.3 |
223.6 |
28.8 |
Step 4 (2000) |
Rm754 |
F |
193.5 |
206.6 |
13.1 |
214.7 |
21.2 |
Step 5 (2000) |
Rm755 |
F |
201.6 |
217.3 |
15.7 |
225.1 |
23.5 |
Table 2. Short-Term And Long-Term Results
Step No. |
Dose (mg/kg body weight) |
Rat No. |
Short-term Result # |
Long-term Result @ |
1
|
2000 |
Rm751 |
Survived |
Survived |
2
|
2000 |
Rm752 |
Survived |
Survived |
3
|
2000 |
Rm753 |
Survived |
Survived |
4
|
2000 |
Rm754 |
Survived |
Survived |
5
|
2000 |
Rm755 |
Survived |
Survived |
#: The survival pattern used to determine whether and how to dose next animal is a short term outcome.
@: The status of the animals at termination is the long term outcome.
Table 3. Individual Clinical Signs and Necropsy Findings
Step |
Dose (mg/kg body weight) |
Rat No. |
S e x |
Observations |
Necropsy Findings |
||||||||||||||||||
Day 1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
|||||||||
30 min. |
1 hour |
2 hours |
3 hours |
4 hours |
|||||||||||||||||||
1
|
2000 |
Rm751 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
2
|
2000 |
Rm752 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
3 |
2000 |
Rm753 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
4 |
2000 |
Rm754 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
5 |
2000 |
Rm755 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
F: Female; min: minutes; N: Normal; NAD: No Abnormality Detected
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- CLP: not classified
- Conclusions:
- Based on the present study results, the estimated acute oral LD50 of Tin Disulfide (CAS 1315-01-1) is greater than 2000 mg/kg body weight in female rats.
- Executive summary:
An acute oral toxicity test (Up-and-Down Procedure) was conducted with female Wistar rats to determine the potential of Tin disulfide (CAS 1315-01-1). The test item was diluted in Milli-Q water and administered as a single oral dose at 2000 mg/kg, first in one female rat, followed by four additional animals at the same dose. Those four animals survived, and the test was concluded. All animals were active and gained body weight during 14 days observation period. All animals were subjected to necropsy at sacrifice and there were no abnormalities observed in any of the rats. Based on the present study results, the estimated acute oral LD50 of Tin disulfide is greater than 2000 mg/kg body weight in female rats.
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