Barium dibenzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-11-20 to 2017-12-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

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 2015-06-05

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Barium dibenzoate

EC Number:

208-551-0

EC Name:

Barium dibenzoate

Cas Number:

533-00-6

Molecular formula:

C14H10O4Ba

IUPAC Name:

barium dibenzoate

Test material form:

solid

Details on test material:

- State of aggregation at room temperature: white solid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dry place at ambient temperature

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:Wl (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 9-10 weeks
- Weight at study initiation: 171 - 192 g
- Fasting period before study: prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted).
- Housing: animals were kept in groups of three in IVC cages, type III H, polysulphone cages; bedding material: Altromin saw fibre bedding
- Diet (ad libitum, for exception refer to "fasting period before study" above): Altromin 1324 maintenance diet for rats and mice
- Water (ad libitum): tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C ± 3 °C
- Relative humidity: 55 % ± 10%
- Air changes: 10 x / hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Aqua ad injectionem (sterile water)

Details on oral exposure:

VEHICLE
- Source: Deltamedica GmbH, Ernst-Wagner-Weg 1-5, 72766 Reutlingen
- Justification for choice of vehicle: this vehicle was chosen due to its non-toxic characteristics
- Lot no.: 612118
- Expiry date: 2019-11-30

Doses:

Starting dose (step 1): 300 mg/kg bw
Step 2: 50 mg/kg bw
Step 3: 50 mg/kg bw

No. of animals per sex per dose:

9 female rats (3 animals/steps)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes, all animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. The animal which died spontaneously during the observation period was necropsied as soon as they died.

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:

> 50 - < 300 mg/kg bw

Based on:

test mat.

Mortality:

300 mg/kg bw: all animals died prematurely
50 mg /kg bw: no animals died

Clinical signs:

other: 300 mg/kg bw after 30-60 min: moderately reduced spontaneous activity, hunched posture, slight piloerection, half eyelid closure, moving the bedding after 60-120 min: prone position, moderate piloerection, anaemia, severely reduced spontaneous activity 5

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

LD50 value (female rat): 50 < LD50 ≤ 300 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.3; H301).