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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
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

Constituent 1
Chemical structure
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.