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EC number: 232-122-7 | CAS number: 7787-59-9
- 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
Carcinogenicity
Administrative data
Description of key information
The test substance is non-carcinogenic in rats after oral administration even at hight dose levels (male: 2397 mg/kg bw/day, female: 1917.8 mg/kg bw/day), reference 7.7 -1.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Version / remarks:
- In 1975 no Guideline on carcinogenicity studies was available.
- Principles of method if other than guideline:
- The study uses less animals and pervormed less obervations than suggested in OECD 451.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- A representative mixture of commercial preparations of bismuth oxychloride was used.
- Species:
- rat
- Strain:
- other: BD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institut für Toxikologie und Chemotherapie, Deutsches Krebsforschungszentrum Heidelberg, D6900 Heidelberg, Deutschland
- Age at study initiation: 100 days
- Weight at study initiation: not available
- Fasting period before study: no details available
- Housing: no details available
- Acclimation period: no details available
ENVIRONMENTAL CONDITIONS
no details available - Route of administration:
- oral: feed
- Vehicle:
- other: mesh containing Altromin animal feed in powder form, sugar and livio oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily
- Post exposure period:
- until the natural death of the animals
- Dose / conc.:
- 10 mg/kg diet
- Dose / conc.:
- 20 mg/kg diet
- Dose / conc.:
- 50 mg/kg diet
- No. of animals per sex per dose:
- 20 males and 20 females per dose
- Control animals:
- yes, concurrent no treatment
- Positive control:
- no
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: recorded monthly
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- After the natural death an autopsy was performed, all important organs were examined and tissues were fixed in 4% formalin for histological investigation.
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- During the 2 year test-period no mortality was observed.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The mean body weights of the test groups did not differ significantly from those of the controls.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No macroscopic findings could be attributed to the treatment and the types and incidence of tumors observed were closly comparable in the test and control groups.
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No histological findings could be attributed to the treatment and the types and incidence of tumors observed were closly comparable in the test and control groups.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- No histological findings could be attributed to the treatment and the types and incidence of tumors observed were closly comparable in the test and control groups. The mammary fibroadenomas and hypophyseal adenomas seen are spontaneous tumors characteristic of the strain.
- Other effects:
- no effects observed
- Description (incidence and severity):
- The mean survival times for the groups of treated animals corresponded approximately to those of the controls, but with a much larger deviations around the mean value.
- Key result
- Dose descriptor:
- NOEC
- Effect level:
- 2 397 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- mortality
- Key result
- Dose descriptor:
- NOEC
- Effect level:
- 1 917.8 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- mortality
- Key result
- Critical effects observed:
- no
- Conclusions:
- The test item is non-carcinogenic in rats after oral administration even at hight dose levels (male: 2397 mg/kg bw/day, female: 1917.8 mg/kg bw/day).
- Executive summary:
The carcinogenic activity of the test item was investigated in a study similar to OECD 451. Over two years, 40 BD rats (20 male, 20 female) per concentration were fed with diet containing 1, 2 or 5% of the test substance. Additionally 60 rats served as untreated control (30 male, 30 female). After the feeding period of two years the treatment was terminated and the animals were observed until their natural death. Body weight was recorded monthly. At autopsy, all important organs were examined and tissues were fixed in 4% formalin for histological investigation. The mean survival of the animals was 810 - 890 days, the mean survival times for the groups of treated animals corresponded approximately to those of the controls, but with much larger deviations around the mean value. The mean body weights did not differ significantly. No macroscopic or histological findings could be attributed to the treatment; the types and incidence of tumors observed were closely comparable in the test and control groups. The test item is therefore non-carcinogenic in rats after oral administration even at high dose levels (male: 2397 mg/kg bw/day, female: 1917.8 mg/kg bw/day).
Reference
Table 1: Total doses administered, mean survival times and tumours found after the feeding of the test item to BD rats for 2 years
Dietary level (%) | No. of rats/group* | Total dose of test item administered (g/kg body weight) | Mean survival time (days) | Tumours observed | ||
Males | Females | Benign | Malignant | |||
0 | 60 | 0 | 0 | 890 (+45 -30) | Mammary fibroadenoma (2) | Mammary carcinoma (1) |
Hypophyseal adenoma (2) | ||||||
1 | 40 | 350 | 280 | 810 (+130 -90) | Mammary fibroadenoma (2) | |
2 | 40 | 700 | 560 | 810 (+110 -80) | Mammary fibroadenoma (1) | |
5 | 40 | 1750 | 1400 | 820 (+110 -80) | Mammary fibroadenoma (2) | |
Hypophyseal adenoma (1) |
* Equal numbers of males and females in each group
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 397 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Publication of 1975, no details available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on carcinogenicity with Bismuth chloride oxide (CAS 7787-59-9) do not meet the criteria for classification according to Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521 and are therefore conclusive but not sufficient for classification.
Additional information
The carcinogenic activity of the test item was investigated in a study similar to OECD 451. Over two years, 40 BD rats (20 male, 20 female) per concentration were fed with diet containing 1, 2 or 5% of the test substance. Additionally 60 rats served as untreated control (30 male, 30 female). After the feeding period of two years the treatment was terminated and the animals were observed until their natural death. Body weight was recorded monthly. At autopsy, all important organs were examined and tissues were fixed in 4% formalin for histological investigation. The mean survival of the animals was 810 - 890 days, the mean survival times for the groups of treated animals corresponded approximately to those of the controls, but with much larger deviations around the mean value. The mean body weights did not differ significantly. No macroscopic or histological findings could be attributed to the treatment; the types and incidence of tumors observed were closely comparable in the test and control groups. The test item is therefore non-carcinogenic in rats after oral administration even at high dose levels(male: 2397 mg/kg bw/day, female: 1917.8 mg/kg bw/day), reference 7.7 -1.
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