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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline with acceptable restrictions: limited reporting

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Acute oral toxicity of inorganic cobalt compounds in rats.
Author:
Speijers GJA, Krajnc EI, Berkvens JM, van Logten MJ
Year:
1982
Bibliographic source:
Fd Chem Toxic 20: 311
Reference Type:
review article or handbook
Title:
Indirect food additives and polymers
Author:
Sheftel VO
Year:
2000
Bibliographic source:
Migration and Toxicology, Lewis Publishers, Boca Raton, Florida

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(10 day observation)
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cobalt(II) acetate tetrahydrate
- Molecular formula (if other than submission substance): Co(CH3COO)2 4H2O
- Molecular weight (if other than submission substance): 249.1 g/mol
- Physical state: solid
- Analytical purity: 99 %
- Other: Apart from chemically combined water the test substance is identical to CAS 71-48-7

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: animal breeding unit, National Institute of Public Health, Bilthoven, the Netherlands
- Weight at study initiation: approx. 100 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
250; 375; 560; 840; 1260 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations: rectal temperature: 1.5, 24 and 48 hours after treatment
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, other: rectal temperature
Statistics:
The oral LD50 values of male and female rats combined were calculated according to the method of 'maximum likelihood ' according to Finney (1971).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
503 mg/kg bw
Remarks on result:
other: LD50 for anhydrous compound (calculated). LD50 for compound tested was 708 (569-880) mg/kg bw (95 % confidence interval).
Mortality:
Individual values not reported.
Clinical signs:
highest dose level: sedation, diarrhea;
respiratory disturbances
time- and dose-related drop in body temperature of 2.5 to 7.5°C
Gross pathology:
hemorrhages and distrophic changes in the liver, kidney and heart

Any other information on results incl. tables

LD50 calculated for Cobalt(II) ion = 168 mg/kg bw.

Applicant's summary and conclusion