Dibismuth trisulphide

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-06-26 to 2013-07-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and OECD guideline compliant study on dibismuth trisulphide

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

, adopted September 7, 2009

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Version / remarks:

of 30 May 2008 (Official Journal L 142, 31/05/2008)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Version / remarks:

, August 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

other: "Traditional protocol" of the OECD guideline no. 403

Limit test:

yes

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:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Species and strain: Hsd.Brl.Han:Wist rat
- Source: Toxi-Coop Zrt. Cserkesz u. 90. H-1103 Budapest Hungary
- Age at study initiation: 10-11 weeks old
- Weight at study initiation: (P) Males: 333-347 g; Females: 218-248 g;


- Housing: Before mating: 2 or 3 animals of the same sex/ cage
- Diet: ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany ad libitum, and tap water from municipal supply, as for human consumption, from 500 mL bottles ad libitum.
- Water: drinking water
- Acclimatization time: 20 days (9 day to the test apparatus)

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 10-15 air exchanges/hour by central air-condition system.
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

clean air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: anodised aluminium Flow Past Exposure Chamber
- Exposure chamber volume: 1.66 L (3x8 animal ports)
- Method of holding animals in test chamber: polycarbonate restraining tubes
- Source and rate of air: 1.03 L/min fresh test atmosphere to each of the 24 animal ports

TEST ATMOSPHERE
- Brief description of analytical method used: Aerosol Light Scattering Photometer

VEHICLE
- Concentration of test material in vehicle (if applicable): 5 mg/L

TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2 to 4 µm

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

Limit test: 5.20 mg/L

No. of animals per sex per dose:

5 animals/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations: During the exposure and daily for 14 days; Weighing: exposure Day 0 (prior to exposure) and Days 1, 3, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed in the study

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.2 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No animal died during the study.

Clinical signs:

other: In four male and two female animals test item related clinical signs were found one hour after completion of the exposure and in one female animal on first day of observation period. The clinical signs represented the decreased and increased activity and

Body weight:

On basis of body weight and body weight gain data, there was no notable test item effect observable in the exposed animals.

Gross pathology:

The dark grey color of test item Dibismuth Trisulfide caused discolouration in the lungs tissues, other local alterations were not found in the respiratory tract.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

In the Acute Inhalation Toxicity Study according to OECD guideline 403 the acute inhalation median lethal concentration (4hr LC50) of test item dibismuth trisulfide in rats was considered to be greater than 5.20 mg/L.

Executive summary:

Under the conditions of the present Acute Inhalation Toxicity Study according to OECD guideline 403, no deaths occurred in a group of ten rats exposed for four hours to a mean achieved atmospheric test item aerosol concentration of 5.20 mg/L. The acute inhalation median lethal concentration (4hr LC50) of test item dibismuth trisulfide, in Wistar Crl:(WI) BR rats, was therefore considered to be greater than 5.20 mg/L. Based on the result of this inhalation toxicity study, dibismuth trisulfide was not classified according to the Globally Harmonized Classification System (GHS) and Regulation (EC) No 12727/2008 (CLP).