Dibismuth trisulphide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-10-02 to 2012-10-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: CLP and Guideline compliant study

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 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

adopted 1992

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

adopted 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats, females were nulliparous and non-pregnant
- Weight at study initiation: Male 249-291 g, Female 209-226 g
- Fasting period before study: food but not water was withheld overnight
- Housing during acclimasation: 3 animals/sex/cage and during the study: animals were housed individually
- Diet: ad libitum (ssniff® SM R/M-Z+H complete diet )
- Water: ad libitum
- Acclimation period: 5 days for the pre-study, 19 days for the main study

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

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 10 % of the total body surface
- The test item was moistened sufficiently with water to ensure good contact with the skin.
- Type of wrap if used: sterile gauze pad below a semi-occlusive plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing: water pre-warmed to body temperature
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: Main-tests: 2000 mg/kg bw; pre-test: Pre-test: 5 mg/kg bw, 50 mg/kg bw, 300 mg/kg bw, 2000 mg/kg bw

Duration of exposure:

single administration for 24 hours

Doses:

Main-test
2000 mg/kg bw

Pre-test:
5 mg/kg bw
50 mg/kg bw
300 mg/kg bw
2000 mg/kg bw

No. of animals per sex per dose:

Main-test: 5 males and 5 females
Pre-tests: 2 females per dose

Control animals:

not required

Details on study design:

Duration of observation period following administration: 14 days
- Frequency of observations and weighing: For the main study, the body weight of all animals were recorded on day 0 (shortly before the treatment), on day 7 and on day 15 (with a precision of 1 g)
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed individually 1 h and 5 h after dosing, and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
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 pathological changes were recorded for each animal on the post mortem record sheets. The animals of preliminary study were humanely sacrificed on day 7.

Statistics:

not applicable

Results and discussion

Preliminary study:

No mortalities occured during the preliminary study

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occured

Clinical signs:

other: General symptoms No behavioural changes or systemic toxic signs were noted during the study. Dermal irritation symptom as erythema was observed on the treatment site. The redness was detected in both sexes and it was very slight (score +1) between Day 1 a

Gross pathology:

All animals survived until the scheduled necropsy on Day 15.
No macroscopic alterations due to the systemic toxic effects of the test item were found.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In this acute dermal toxicity study with the test item Dibismuth trisulfide (Bi2S3), the obtained acute dermal LD50 value was greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.

Executive summary:

An acute dermal toxicity study was performed with the test item dibismuth trisulphide in Crl:(WI)BR rats, in compliance with OECD Guideline No. 402 and EU Method B.3. A limit test was carried out. A single group of male and female animals (n=5 animals/sex) was exposed to the test item at 2000 mg/kg bw by dermal route. The test item was applied in its original form and left in contact with the skin for 24 hours, followed by a 14-day observation period.

No mortality occurred during the study. Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. The test item caused dermal irritation symptoms as slight erythema between Day 1 and Day 3. There was no test item related effect on body weight development. No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy.

In this acute dermal toxicity study with the test item Dibismuth trisulfide (Bi2S3), the obtained acute dermal LD50 value was greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.