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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-09-19 to 2012-09-27
- 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:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22.07.2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- (30 May 2008 Amendment 06.07.2012)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- March 2003
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Sex: female, nulliparous, non pregnant
Age of animals: young adult mice, 11-12 weeks (at start of the experiment)
Body weight range at starting: 17.9 -22.8 g
The weight variation in animals involved in the study did not exceed ± 20 % of the mean weight.
Acclimatization time: 7 days
Housing during acclimatization period: grouped caging in small groups
Housing during the test: grouped caging (5 animals/cage)
Cage type: type II. polypropylene/polycarbonate
Bedding: laboratory bedding
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 – 70 %
Diet: ssniff® SM R/M-Z+H complete diet for rats and mice produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany
Water: tap water from municipal supply, as for human consumption, from a bottle ad libitum
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- DMSO
Challenge
- Route:
- other: not applicable because LLNA
- Vehicle:
- DMSO
- Positive control substance(s):
- yes
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- Based on the preliminary test results 100 % concentration of the test item (formulated in the selected vehicle of DMSO) was selected as the maximum concentration used in the main test in order to test the highest concentration possible. The test item was tested also at two additional, lower concentrations (50 % and 25 %) according to the relevant guidelines.
- No. of animals per dose:
- 5
- Details on study design:
- Each mouse was topically treated with 25 μL of the appropriate formulations of the test item, of the positive control substance (positive control
group) or of the vehicles (negative control groups). The formulations were applied, with a pipette, on the dorsal surface of each ear. Each animal wasdosed once a day for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Use of the individual approach enabled the performance of a statistical analysis of the data. Statistical analysis was performed by SPSS/PC+ (4.0.1) software package. The heterogeneity of variance between groups was checked by Bartlett's test for the measured DPM values corrected with the mean background value. Since no significant heterogeneity was detected, a one-way analysis of variance was carried out. Since the result was positive Duncan's Multiple Range test was used to assess the significance of inter-group differences. Significance of the positive control response was evaluated by T-test versus control. Significance of the dose-response was evaluated by linear regression made with Microsoft Excel Software.
Results and discussion
- Positive control results:
- The positive control group animals were treated with 25 % HCA solution (dissolved in AOO) concurrent to the test item groups. No mortality, cutaneous reactions or signs of toxicity were observed in the positive control group.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The mean DPM values per treatment group were as follows: negative control for the PC:AOO: 946.3 DPM positive control 25% HCA in AOO: 13518.3 DPM Test item: 100 % in DSMO: 2462.7 DPM 50 % in DMSO: 2394.9 DPM 25 % in DMSO: 3711.5 DPM Negative (vehicle) control for the test item DMSO: 1126.3
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- The mean DPM values per treatment group were as follows: negative control for the PC:AOO: 946.3 DPM positive control 25% HCA in AOO: 13518.3 DPM Test item: 100 % in DSMO: 2462.7 DPM 50 % in DMSO: 2394.9 DPM 25 % in DMSO: 3711.5 DPM Negative (vehicle) control for the test item DMSO: 1126.3
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present Local Lymph Node Assay, Dibismuth trisulfide tested at the maximum attainable concentration of 100 %
(i.e. 1 g/mL) and at concentrations of 50 % and 25% as suspension in a suitable vehicle (Dimethyl sulfoxide) was shown to have no sensitization
potential. - Executive summary:
The aim of this study was to determine the skin sensitization potential of Dibismuth trisulfide in the Local Lymph Node Assay (LLNA). Visually larger lymph nodes than the control was observed in the positive control group only. The observed SI values were 2.2, 2.1 and 3.3 at concentrations of 100 %, 50 % and 25 % test item, respectively. The observed proliferation values were statistically significant in all test item treated groups (Mann-Whitney U-test was performed using the individual DPM values corrected with the mean background value) compared to the relevant vehicle control (DMSO). No biologically relevant dose-related response was observed. Since the test was valid and no sign of systemic toxicity or irritation was observed, the proliferation values obtained are considered to reflect the real potential of the test item to cause lymphoproliferation in the Local Lymph Node Assay. Although the observed proliferation values were statistically significantly increased in all test item treated groups compared to the control and the SI value observed at concentration of 25 % was above the threshold value of 3, it was considered that these observations did not indicate sensitization potential of the test item Dibismuth trisulfide. This is also being supported by the fact that no effect was observed at 50% test concentration and therefore the effect observed at 25 % test concentration was considered to be coincidental. No dose-response effect was observed. It is also considered that the increased proliferation values and the borderline result at 25% might have been a consequence of a slight irritation effect rather than a sensitization effect. According to evaluation criteria of the relevant guidelines, although borderline result was observed for the test item and the increase of the lymphoproliferation proved to be statistically significant, the lack of a biologically relevant dose-related response is considered as evidence that Dibismuth trisulfide is not a sensitizer.
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