Barium bis(dihydrogenorthophosphate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Barium bis(dihydrogenorthophosphate)

EC Number:

236-715-1

EC Name:

Barium bis(dihydrogenorthophosphate)

Cas Number:

13466-20-1

Molecular formula:

Ba(H2PO4)2

IUPAC Name:

barium bis(dihydrogenorthophosphate)

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, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 173 - 194 g
- Fasting period before study: approx. 16 hours before administration
- Housing: groups of three in MAKROLON cages (type III plus)
- Diet: ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: hydroxypropyl methylcellulose

Details on oral exposure:

VEHICLE
0.8% aqueous hydroxypropyl methylcellulose

MAXIMUM DOSE VOLUME APPLIED: 1.3 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: according to the OECD/EC guidelines

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

6

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 min, as well as 3, 6 and 24 hours after administration. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: During the follow-up period of two weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

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

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

2000 mg/kg bw: 1/3 in the first step and 2/3 in the second step
300 mg/kg bw: no animal died prematuraly

Clinical signs:

2000 mg/kg bw: slightly to moderately reduced motility, slight to moderate ataxia and slightly to moderately reduced muscle tone in 4 of 6 animals, pilo-erection in all 6 animals and slight dyspnoea in 3 of 6 animals; In addition, pulpy faeces with offensive smell was observed in 2 of 6 animals and a reddish-brown wetted lower jar was noted in 1 of 6 animals.
300 mg/kg bw: no clinical signs observed

Body weight:

All surviving animals gained the expected weight at the end of the study period.

Gross pathology:

No pathological changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Category 4 based on CLP criteria (EU GHS criteria according to Regulation (EC) No. 1272/2008)

Conclusions:

Under the present test conditions a LD50 value for Barium bis(dihydrogenorthophosphate between 300 and 2000 mg/kg bw was observed. According to OECD Guideline 423 Annex 2d a LD50 cut off = 2000 mg/kg bw was estimated. Therefore, CLP criteria for Category 4 according to Regulation (EC) No. 1272/2008 are met.