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EC number: 215-716-0 | CAS number: 1345-07-9
- 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:
- 2012-08-14 to 2012-08-30
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- , adopted 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- , Official Journal L 142, 31/05/2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- , adopted: December, 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Dibismuth trisulphide
- EC Number:
- 215-716-0
- EC Name:
- Dibismuth trisulphide
- Cas Number:
- 1345-07-9
- Molecular formula:
- Bi2S3
- IUPAC Name:
- dibismuth trisulphide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test animals:
-Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
-Sex: Female, nulliparous and non pregnant animals
- Age of animals: Young adult rats, 10 weeks old in group 1 and 2
-Body weight range at starting (first step): 212-219 g
- Body weight range at starting (second step): 214-221 g
- Housing: 3 animals/sex/cage
- Diet: ad libitum (ssniff® SM R/M-Z+H complete diet )
- Water: ad libitum
- Acclimatisation time: 26 days in first step and 27 days in second step
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8-12 air exchanges/hour by central air-condition system.
- Photoperiod: Artificial light, from 6 a.m. to 6 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- vegetable oil
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals/group
- Control animals:
- no
- Details on study design:
- Testing Procedure
A single oral administration - followed by a fourteen-day observation period - was performed by gavage. The day before treatment the animals were
fasted. The food but not water was withheld overnight. Animals were weighed before the application and the food was given back 3 hours after the treatment.
Dose Level
Starting dose was selected on the basis of the available information about the test item. The acute toxic class method was carried out involving a
stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats.
Observations
Mortality
Inspection for signs of morbidity and mortality were made twice daily at the beginning and end of the working day.
Clinical Observations
Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central
nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation,
diarrhoea, lethargy, sleep and coma.
Body weight
The body weight were recorded on day 0 (shortly before the treatment), at day 7 and at day 15 on all animals with a precision of 1 g.
Pathology
All animals were subjected to gross pathology. All animals were exsanguinated under isoflurane anaesthesia. After examination of the external appearance the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross pathologicalchanges were recorded for each animal on the post mortem record sheets.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item Dibismuth trisulfide did not induce mortality following a single oral administration to female rats at a dose of 2000 mg/kg bw.
All female rats survived the performed treatment until the end of the 14-day observation period. - Clinical signs:
- other: No treatment related symptoms were observed throughout the treatment day and 14-day post-treatment period at any groups of the female animals.
- Gross pathology:
- All animals treated with 2000 mg/kg bw dose of test item survived until the scheduled necropsy on Day 15.
No pathological changes were found related to the effect of the test item during the macroscopic examination of animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The method used is not intended to allow for the calculation of a precise LD50 value. However, for this acute oral toxicity study with the test item
Dibismuth trisulfide in rats the determined LD50 is greater than 2000 mg/kg bw (LD50 ≥ 2000 mg/kg bw).According to the current EU Regulation
on classification, labelling and packaging (CLP) (EC) No 1272/2008 no classification is required for the test item Dibismuth trisulfide. - Executive summary:
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level. Therefore, treatment with 2000 mg/kg bw was repeated on further three female rats. Again, no animal died in the second step, thus, no further testing was required. The stopping criteria of Annex 2d of OECD Guideline No. 423 were met. A single administration was performed by oral route and was followed by a 14-day observation period.
The test item Dibismuth trisulfide did not induce mortality following a single oral administration to female rats at a dose of 2000 mg/kg bw. There were no toxic clinical signs and any related to the effect of the test item found in body weights and body weight gains during the study. Autopsy revealed no treatment related pathological changes.
The method used is not intended to allow for the calculation of a precise LD50 value. However, for this acute oral toxicity study with the test item Dibismuth trisulfide in rats the determined LD50 is greater than 2000 mg/kg bw (LD50 ≥ 2000 mg/kg bw).According to the current EU Regulation on classification, labelling and packaging (CLP) (EC) No 1272/2008 no classification is required for the test item Dibismuth trisulfide.
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