Dibismuth trisulphide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-08-14 to 2012-08-30

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

, adopted 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

, Official Journal L 142, 31/05/2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

, adopted: December, 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dibismuth trisulphide

EC Number:

215-716-0

EC Name:

Dibismuth trisulphide

Cas Number:

1345-07-9

Molecular formula:

Bi2S3

IUPAC Name:

dibismuth trisulphide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Test animals:
-Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
-Sex: Female, nulliparous and non pregnant animals
- Age of animals: Young adult rats, 10 weeks old in group 1 and 2
-Body weight range at starting (first step): 212-219 g
- Body weight range at starting (second step): 214-221 g
- Housing: 3 animals/sex/cage
- Diet: ad libitum (ssniff® SM R/M-Z+H complete diet )
- Water: ad libitum
- Acclimatisation time: 26 days in first step and 27 days in second step

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8-12 air exchanges/hour by central air-condition system.
- Photoperiod: Artificial light, from 6 a.m. to 6 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

vegetable oil

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 animals/group

Control animals:

no

Details on study design:

Testing Procedure
A single oral administration - followed by a fourteen-day observation period - was performed by gavage. The day before treatment the animals were
fasted. The food but not water was withheld overnight. Animals were weighed before the application and the food was given back 3 hours after the treatment.

Dose Level
Starting dose was selected on the basis of the available information about the test item. The acute toxic class method was carried out involving a
stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats.

Observations
Mortality
Inspection for signs of morbidity and mortality were made twice daily at the beginning and end of the working day.
Clinical Observations
Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central
nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation,
diarrhoea, lethargy, sleep and coma.
Body weight
The body weight were recorded on day 0 (shortly before the treatment), at day 7 and at day 15 on all animals with a precision of 1 g.
Pathology
All animals were subjected to gross pathology. All animals were exsanguinated under isoflurane anaesthesia. After examination of the external appearance the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross pathologicalchanges were recorded for each animal on the post mortem record sheets.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The test item Dibismuth trisulfide did not induce mortality following a single oral administration to female rats at a dose of 2000 mg/kg bw.
All female rats survived the performed treatment until the end of the 14-day observation period.

Clinical signs:

other: No treatment related symptoms were observed throughout the treatment day and 14-day post-treatment period at any groups of the female animals.

Gross pathology:

All animals treated with 2000 mg/kg bw dose of test item survived until the scheduled necropsy on Day 15.
No pathological changes were found related to the effect of the test item during the macroscopic examination of animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The method used is not intended to allow for the calculation of a precise LD50 value. However, for this acute oral toxicity study with the test item
Dibismuth trisulfide in rats the determined LD50 is greater than 2000 mg/kg bw (LD50 ≥ 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.

Executive summary:

The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level. Therefore, treatment with 2000 mg/kg bw was repeated on further three female rats. Again, no animal died in the second step, thus, no further testing was required. The stopping criteria of Annex 2d of OECD Guideline No. 423 were met. A single administration was performed by oral route and was followed by a 14-day observation period.

The test item Dibismuth trisulfide did not induce mortality following a single oral administration to female rats at a dose of 2000 mg/kg bw. There were no toxic clinical signs and any related to the effect of the test item found in body weights and body weight gains during the study. Autopsy revealed no treatment related pathological changes.

The method used is not intended to allow for the calculation of a precise LD50 value. However, for this acute oral toxicity study with the test item Dibismuth trisulfide in rats the determined LD50 is greater than 2000 mg/kg bw (LD50 ≥ 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.