Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trialuminium bismuth hexaoxide
EC Number:
235-552-3
EC Name:
Trialuminium bismuth hexaoxide
Cas Number:
12284-76-3
Molecular formula:
Al3BiO6
IUPAC Name:
bismuth;oxido(oxo)alumane
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
RccHan: WIST
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 160 to 186 g
- Fasting period before study: Yes (overnight before dosing)
- Housing: Housed in groups of up to 4 in suspended solid-floor polypropylene cages furnished with wood flakes.
- Diet (e.g. ad libitum): Teklad Global Rodent Diet
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 mg/mL or 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Standard vehicle

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
1 female at 300 mg/kg and 5 at 2000 mg/kg
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 30 minutes, 1, 2 and 4 hours after dosing and then daily for up to 14 days. Individual bodyweights were recorded on Day 0 (the day of dosing), and on Days 7 and 14.
- Necropsy of survivors performed: yes
Statistics:
Not performed

Results and discussion

Preliminary study:
One animal dosed at 300 mg/kg and another dosed at 2000 mg/kg showed no clinical signs of mortality.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed
Clinical signs:
other: No signs of systemic toxicity were noted during the observation period
Gross pathology:
No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test substance in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (not classified in accordance with UN GHS and EU CLP).