Barium dodecairon nonadecaoxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The test was performed according to recommended guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Barium dodecairon nonadecaoxide

EC Number:

234-974-5

EC Name:

Barium dodecairon nonadecaoxide

Cas Number:

12047-11-9

Molecular formula:

Ba.Fe12O19

IUPAC Name:

dodecairon(3+) barium(2+) nonadecaoxidandiide

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Age and weight range (at order) : 6 to 7 weeks old, 150 to 174 grams

Temperature range: : 22°C ± 2°C

Relative humidity range: : 55% ± 15%

Room lighting: : Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours

Air changes: : Approximately 15 to 25 air changes per hour

Mean body weight of the animals (at pre-test phase): 251 grams

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Doses:

Sighting studies:

A sighting study was performed in which a single female animal was dosed at 300 mg/kg, followed by 14-days observation period.
A second sighting study was performed in the same manner dosing one female animal at 2000 mg/kg.

Main study:

A main study was performed using 4 additional female rats which were dosed at 2000 mg/kg.

No. of animals per sex per dose:

Sighting studies
Dose level Animal number (mg/kg) Animal number (Females)
300 1
2000 1

Main study
Dose level Animal number (mg/kg) Animal number (Females)
2000 4

Control animals:

no

Results and discussion

Preliminary study:

A sighting study was performed in which a single female animal was dosed at 300 mg/kg, followed by 14-days observation period.
A second sighting study was performed in the same manner dosing one female animal at 2000 mg/kg.

Sighting studies
Dose level Animal number (mg/kg) Animal number (Females)
300 1
2000 1

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the 14-day observation period.

Clinical signs:

other: No clinical signs were observed during the 14-day observation period.

Gross pathology:

No abnormalities were observed at necropsy examination performed at the end of the observation period on the all animals treated.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Study results indicate that the barium hexaferrite does not cause any acute toxic effect when it is administered at 2000 mg/kg by oral route.
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substance should not be classified for oral acute toxicity.