Registration Dossier
Registration Dossier
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EC number: 231-177-4 | CAS number: 7440-69-9
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: limited details on results reported. Only 20 animals/sex/dose group
Data source
Reference
- Reference Type:
- publication
- Title:
- Absence of Carcinogenic Activity in Rats after oral administration of high doses of bismuth oxychloride
- Author:
- Preussmann R and Ivankovic S
- Year:
- 1 975
- Bibliographic source:
- Fd Cosmet Toxicol (1975) 33, pp 543-544
Materials and methods
- Principles of method if other than guideline:
- 2-year feeding study for carcinogenicity in rats
- GLP compliance:
- no
Test material
- Reference substance name:
- Bismuth
- EC Number:
- 231-177-4
- EC Name:
- Bismuth
- Cas Number:
- 7440-69-9
- Molecular formula:
- Bi
- IUPAC Name:
- bismuth
- Details on test material:
- Thc BiOCl used was a representative mixture of commercial preparations of the product.
The purity was indicated to be confirmed
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: BD rats of the testing facility
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily
- Post exposure period:
- none
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1, 2 and 5%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
up to 1750 mg/kg bw (males) and 1400 mg/kg bw (females)
Basis:
other: calculated from dietary intake
- No. of animals per sex per dose:
- 20 (test group)
30 (control group) - Control animals:
- yes, plain diet
- Details on study design:
- Body weight was recorded monthly. At autopsy, all important organs {including the brain and nervous
system were examined, and tissues were fixed in 4% formalin for histological investigation.
Results and discussion
Results of examinations
- Body weight and weight changes:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
