Barium di(acetate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-12-07 to 2017-12-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001-12-17

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2017-05-08

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Barium di(acetate)

EC Number:

208-849-0

EC Name:

Barium di(acetate)

Cas Number:

543-80-6

Molecular formula:

Ba(C2H3O2)2

IUPAC Name:

barium di(acetate)

Test material form:

solid: particulate/powder

Details on test material:

- State of aggregation: white solid (powder)

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at +10°C to 25°C, stored in the tightly closed original container in and in a cool, dry and well-ventilated place

Test animals

Species:

rat

Strain:

other: Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 187 - 200 g
- Fasting period before study: feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum.
- Housing: during the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages (type III plus); bedding material: granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany)
- Diet: commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum): drinking water
- Acclimation period: at least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C ± 3 °C (maximum range)
- Relative humidity: 55 % ± 10 % (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.8% aqueous hydroxypropylmethylcellulose

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: 0.8% aqueous hydroxypropylmethylcellulose was chosen as vehicle as it is known not to produce toxic effects.
- Batch no.: 16H 23-B02-333146 (supplier: Fagron GmbH & Co., 22885 Barsbüttel, Germany)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

2000 mg/kg/bw: 3 female rats (3 animals/step)
300 mg/kg/bw: 6 female rats (3 animals/step)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed before and immediately, 5, 15, 30 and 60 minutes, as well as 3, 6 and 24 hours after administration. During the follow-up period of two weeks,the surviving animals were observed at least once a day until all symptoms subsided, thereafter each working day. Observations on prematurely deceased animals were made at least once daily to minimize loss of animals during the study.
Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study and at death. Changes in weight were calculated and recorded.
- Necropsy of survivors performed: yes, at the end of the experiments, all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. Autopsy and macroscopical inspection of animals which died prematurely were carried out as soon as possible after exitus.

Statistics:

No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).

Results and discussion

Preliminary study:

not applicable

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 (cut off value): 500 mg/kg bw

Mortality:

2000 mg/kg bw: all 3 animals died within 60 minutes after administration.
300 mg/kg bw: 1/6 animals died (animal with clinical signs as described in the field "clinical signs" below)

Clinical signs:

other: 2000 mg/kg bw: slightly to moderately reduced motility, slight to moderate ataxia, slightly to moderately reduced muscle tone, slight to moderate dyspnoea, abdominal position, salivation and pilo-erection in all animals. 300 mg/kg bw: slightly reduced mot

Gross pathology:

No findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50 (female rats): 300 < LD50 < 2000 mg/kg bw (LD50 cut off value: 500 mg/kg bw)
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is classified as acute toxic via the oral route (Cat.4; H302).