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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP-compliant guideline study with the following deviations: - According to the guideline, healthy young adults should be used. The age of the rats was missing in this report. - The analytical purity of the test substance is not indicated in the report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Barium sulphide
EC Number:
244-214-4
EC Name:
Barium sulphide
Cas Number:
21109-95-5
Molecular formula:
BaS
IUPAC Name:
barium(2+) sulfanediide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): barium sulfide
- Analytical purity: not stated in the report. But based on information from the study sponsor it can be assumed that the purity of the test substance is 75%.
- pH of suspensions: ca. 13
- appearance: dark grey powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. A. Ivanovas, 7964 Kisslegg/Allgäu
- Age at study initiation: Not reported
- Weight at study initiation: Males: 95-125 g; Females: 90-120 g
- Housing: Group housing of five animals per sex per cage in labelled Makrolon cages (type III) containing sawdust bedding material (Fa. Brandenburg, 2849 Goldenstedt-Arkeburg).
- Diet (ad libitum except overnight prior to and approx. 4 hours after dosing): Pelleted rodent diet (Ssniff R10 pellets, Ssniff Versuchstierdiäten, 4770 Soest/Westf.
- Water (ad libitum): Tap water
- Acclimation period: 5 days before start of treatment

ENVIRONMENTAL CONDITIONS
Animals were housed in a controlled environment.
- Temperature: ca. 20°C
- Relative humidity: 40 - 60 %
- Air changes: Approx. 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 1%

MAXIMUM DOSE VOLUME APPLIED: 5.0 ml/kg
The control animals received the vehicle alone.
Doses:
215 mg/kg, 261 mg/kg, 316 mg/kg, 383 mg/kg
No. of animals per sex per dose:
5 male / 5 female
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day of dosing animals were observed for signs of reaction to treatment at frequent intervals. On subsequent days animals were observed at leaste once daily. Individual bodyweights were recorded on the day of dosing and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
R Core Team (2012). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. ISBN 3-900051-07-0, URL http://www.R-project.org/
Please refer to the attachement

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
275 mg/kg bw
Based on:
test mat.
95% CL:
210 - 361
Remarks on result:
other: R Core Team (2012). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. ISBN 3-900051-07-0, URL http://www.R-project.org/
Sex:
male
Dose descriptor:
LD50
Effect level:
336 mg/kg bw
Based on:
test mat.
95% CL:
321 - 351
Remarks on result:
other: R Core Team (2012). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. ISBN 3-900051-07-0, URL http://www.R-project.org/
Sex:
male/female
Dose descriptor:
LD50
Effect level:
307 mg/kg bw
Based on:
test mat.
95% CL:
275 - 343
Remarks on result:
other: R Core Team (2012). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. ISBN 3-900051-07-0, URL http://www.R-project.org/
Mortality:
Number of dead males per dose:
Control: 0/5
215 mg/kg: 0/5
261 mg/kg: 0/5
316 mg/kg: 2/5 (within 4 hours after dosing)
383 mg/kg: 4/5 (within 4 hours after dosing)

Number of dead females per dose:
Control: 0/5
215 mg/kg: 0/5
261 mg/kg: 4/5 (within 4 hours after dosing)
316 mg/kg: 3/5 (within 4 hours after dosing)
383 mg/kg: 4/5 (within 4 hours after dosing)
Clinical signs:
Pilo-erection and hunched posture was observed in the control animals on the day of dosing. Clinical signs observed within the first three days in rats treated with barium sulfide included pilo-erection, hunched posture, pallor of extremities, decreased motility, abnormal gait (waddling), loss of righting reflex, decreased respiration, increased respiration, gasping or laboured respiration, diarrhoea convulsions, coarse body tremors, tremors and loss of coordination.
Recovery of the survivors was complete by day 4 as judged by external apperance and behaviour. One animal exposed to 261 mg/kg, that lost weight showed pilo-erection and pallor of extremities on day 13 accompanied by hunched posture on day 14 and 15.
Body weight:
The animals showed normal weight gain throughout the study. Bodyweight gain was poor in one female rat at 261 mg/kg. Bodyweight loss was observed in one male rat at 261 mg/kg.
Gross pathology:
Autopsy mainly revealed congestion of liver and spleen and red colouration, haemorrhaging and congestion of the gastric mucosa in rats that died during the study.
Other findings:
The observations by autopsy in rats died during the study (at doses of 261, 316 and 383 mg/kg bw) were as follows: congestion of liver, congestion of spleen, red coloration of the glandular mucous membrane of the stomach, red colored contents in ileum or milky white ileum contents, mucous membrane of the stomach congested and/or hemorrhaged.

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An LD50 of 307 mg/kg bw has been calculated for males/females for barium sulfide. The LD50 for males is 336 mg/kg bw and for females an LD50 of 275 mg/kg bw. has been calculated (see attachment to this robust study summary).
According to Regulation (EC) 1272/2008 the most sensitive species should be chosen for the purposes of the Chemical Safety Assessment. Since data is available for males and females, and females are more sensitive than males, the LD50 value for females was used for classification.
According to the test result the substance has to be classified as toxic if swallowed (H301) due to the fact that mortality was observed at dose levels of < 300 mg/kg bw (LD50 female: 275 mg/kg bw).

Executive summary:

According to 67/548/EEC barium sulfide has to be classified as harmful if swallowed (LD50 >200 and < 2000 mg/kg bw) and labeled with Xn; R22.