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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:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals 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:
No clinical signs were observed during the 14-day observation period.
Body weight:
Body weight changes observed were within the expected range for this strain and age of animals.
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.