Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions - The purity and stability of the test material were not stated. Minor deviations with no effect on the study results: -According to the guideline, the volume administered to the animals should not exceed 1ml/100 g bw. The information on the volume administered was missing in the study report. -According to the guideline, the diet and environmental conditions shoud be stated in the test report. This information was missing in this report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
, adopted 1987-02-24
Deviations:
yes
Remarks:
, see "rational for reliability"
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cobalt oxide tricobalt tetraoxide
- Batch No.: S90673
No further nformation on the test material was stated.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, MA
- Weight at study initiation: males mean body weight (fasted): 309.2 +/- 14.4 g; females mean body weight (fasted): 210.8 +/- 11.7 g
- Fasting period before study: Food was withheld the night prior to dosing
- Housing: Individually housed in wire mesh bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days
No further information on the test animals was stated.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
The test item was suspended in corn oil. The concentration prepared was 50 %.
DOSAGE PREPARATION:
Weighed 20 gm test article, Q.S. to 40 ml with diluent.
No further information on the oral exposure was stated.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 males/5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: All animals were observed frequently on the day of dosing and twice daily for the remainder of the study. All external signs of toxicity or pharmacological effects were noted. Body weights were recorded initially, on days 8 and 15 or at death.
- Necropsy of survivors performed: Yes
All animals that died and those sacrificed at termination of the study were subjected to a gross necropsy and abnormalities were noted.
No further information on the study design was stated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
All animals survived the 15 day post-dose observation period.
Clinical signs:
All animals appeared normal throughout the study.
Body weight:
A weight gain was noted from study initiation to termination.
Gross pathology:
No noteworthy findings were made at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 (male and females rats) for Cobalt oxide tricobalt tetraoxide is:
LD50 (male and females rats) > 5000 mg/kg
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified.