Registration Dossier
Registration Dossier
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EC number: 215-716-0 | CAS number: 1345-07-9
Endpoint summary
Administrative data
Description of key information
The acute toxicity of dibismuth trisulfide was determined according to OECD guideline 423 in rats. The LD50 was higher than 2000 mg/kg bw. According to the current EU Regulation on classification, labelling and packaging (CLP) (EC) No 1272/2008 or Directive 67/548/EEC (DSD) criteria no classification is required for the test item dibismuth trisulfide. Supporting data from bismuth confirm this conclusion.
Under the conditions of the present Acute Inhalation Toxicity Study according to OECD guideline 403, no deaths occurred in a group of ten rats exposed for four hours to a mean achieved atmospheric test item aerosol concentration of 5.20 mg/L. The acute inhalation median lethal concentration (4hr LC50) of test item dibismuth trisulfide, in Wistar Crl:(WI) BR rats, was therefore considered to be greater than 5.20 mg/L. Based on the result of this inhalation toxicity study, dibismuth trisulfide was not classified according to the Globally Harmonized Classification System (GHS) and Regulation (EC) No 12727/2008 (CLP).
In an acute dermal toxicity study with the test item dibismuth trisulfide according to OECD guideline 402, the obtained acute dermal LD50 value was above 2000 mg/kg bw in male and female Crl:(WI)BR rats. According to the results from the acute dermal toxicity study, no classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- CLP and Guideline compliant study.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- CLP and Guideline compliant study.
Additional information
Oral:
The acute toxicity of dibismuth trisulfide was determined according to OECD guideline 423 in rats. The LD50 was higher than 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.
In addition, the LD50 for bismuth was determined according to OECD guideline 401. Based on the results, the LD50 value was determined to be higher than 2000 mg/kg bw for bismuth in both sexes. Since bismuth and dibismuth trisulfide are both almost insoluble inorganic compounds and exhibit comparable properties the results from bismuth were used via read-across as supporting data. The calculated LD50 for dibismuth trisulfide is above 2460 mg/kg bw.
Inhalation:
Under the conditions of the present Acute Inhalation Toxicity Study according to OECD guideline 403, no deaths occurred in a group of ten rats exposed for four hours to a mean achieved atmospheric test item aerosol concentration of 5.20 mg/L. The acute inhalation median lethal concentration (4hr LC50) of test item dibismuth trisulfide, in Wistar Crl:(WI) BR rats, was therefore considered to be greater than 5.20 mg/L. Based on the result of this inhalation toxicity study, dibismuth trisulfide was not classified according to the Globally Harmonized Classification System (GHS) and Regulation (EC) No 12727/2008 (CLP).
Dermal:
In an acute dermal toxicity study with the test item dibismuth trisulfide according to OECD guideline 402, the obtained acute dermal LD50 value was above 2000 mg/kg bw in male and female Crl:(WI)BR rats. According to the results from the acute dermal toxicity study, no classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.
Justification for selection of acute toxicity – oral endpoint
Most reliable study.
Justification for selection of acute toxicity – inhalation endpoint
Most reliable study.
Justification for selection of acute toxicity – dermal endpoint
Most reliable study.
Justification for classification or non-classification
According to the results from the acute oral, inhalation or dermal toxicity studies, no classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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