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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:
weight of evidence
Study period:
March/April 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.
Cross-reference
Reason / purpose:
reference to same study

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Barium chloride anhydrous
- pH: ca. 6.2
- Analytical purity: not stated in the report.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. A. Ivanovas, 7964 Kisslegg/Allgäu
- Age at study initiation: Not reported
- Weight at study initiation: Males: 105-135 g; Females: 105-120 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:
464 mg/kg, 562 mg/kg, 681 mg/kg, 825 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 attachment

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
619 mg/kg bw
Based on:
test mat.
95% CL:
506 - 756
Sex:
male
Dose descriptor:
LD50
Effect level:
676 mg/kg bw
Based on:
test mat.
95% CL:
590 - 774
Sex:
male/female
Dose descriptor:
LD50
Effect level:
645 mg/kg bw
Based on:
test mat.
95% CL:
612 - 681
Mortality:
Number of dead males per dose:
Control: 0/5
464 mg/kg: 0/5
562 mg/kg: 0/5
681 mg/kg: 4/5 (within 6 hours after dosing)
825 mg/kg: 4/5 (within 6 hours after dosing)

Number of dead females per dose:
Control: 0/5
464 mg/kg: 0/5
562 mg/kg: 3/5 (within 6 hours after dosing)
681 mg/kg: 2/5 (within 6 hours after dosing)
825 mg/kg: 5/5 (within 6 hours after dosing)
Clinical signs:
Signs of reaction to treatment included pilo-erection, hunched posture, pallor of extremities, abnormal gait (waddling), increased or decreased respiratory rate, irregular respiration, gasping respiration, increased or decreased motility, diarrhoea, sedation, loss of righting reflex, loss of coordination, paralysis of the hind legs, tremors and coarse body tremors. Complete recovery was evident in surviving animals by day 3 as judged by external appearance and behaviour.
Body weight:
The animals showed normal weight gain throughout the study.
Gross pathology:
Autopsy mainly revealed congestion of liver and spleen. Haemorrhaging and swelling of the glandular gastric mucosa was also observed.

Any other information on results incl. tables

Based on the resuls of this study, an LD50 of 645 mg/kg bw has been calculated for males and females for BaCl2.

According to the test result the substance has to be classified as harmful im swallowed (Xn; R22) due to the fact that mortality was observed at dose levels of > 200 mg/kg bw (according to 67/548/EEC) and toxic category IV (LD50 >300 and<2000 mg/kg bw.) according to GHS.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, an LD50 of 645 mg/kg bw has been calculated for males and females for BaCl2.
According to the criteria specified by Directive 67/548/EC, Regulation (EC) No 1272/2008 and subsequent regulations the test item would be harmful and requires classification (Xn; R22 according to 67/548/EEC and toxic category IV according to GHS).
Executive summary:

In a GLP compliant acute oral toxicity study, performed according to OECD guideline 401, the test item BaCl2 was administered to groups of 5 male and 5 female Sprague Dawley rats at dose levels of 464, 562, 681 and 825 mg/kg body weight.

Mortalities occurred within 6 hours after dosing. Signs of reaction to treatment included pilo-erection, hunched posture, pallor of extremities, abnormal gait (waddling), increased or decreased respiratory rate, irregular respiration, gasping respiration, increased or decreased motility, diarrhoea, sedation, loss of righting reflex, loss of coordination, paralysis of the hind legs, tremors and coarse body tremors. Complete recovery was evident in surviving animals by day 3 as judged by external appearance and behaviour.

Autopsy mainly revealed congestion of liver and spleen. Haemorrhaging and swelling of the glandular gastric mucosa was also observed.

The animals showed normal weight gain throughout the study.

In conclusion, the LD50 of BaCl2 is calculated to be 645 mg/kg body weight by oral route in the rat.