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Diss Factsheets

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
Reference
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

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

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).

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.