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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:
1987-09-08 to 1987-09-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
the purity of the test material was missing in the study report Minor deviations from the guideline: - in this study only males were given the test item. According to the guideline, after completion of the study in one sex one group of the other sex is dosed to establish that animals of this sex are not markedly more sensitive to the test substance. Where adequate information is available to demonstrate that the animals of the sex tested are markedly more sensitive, testing in animals of the other sex may be dispensed with. If males are more sensitive to the test item than females was not stated in the report, but since the LD50 for males lies above 10000 mg/kg it is assumed that the LD50 for the females is also above 2000 mg/kg and no testing of females is needed. - the acclimatisation period in this study was four days - the administered test volume was not stated - information on temperature and relative humidity (holding conditions) were missing. - time of appearance and disappearance of clinical signs was not stated. In addition, number of animals displaying signs of toxicity was not shown. - bodyweight should be determined at the day of administration and then weekly thereafter and at death. The body weight was determined at the day of administration and at the end of the study (Day 14). - the age of the rats was missing in the study report. Since the weight of the rats was between 200 and 300 g, it was assumed that the rats were young adults.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987-02-24
Deviations:
yes
Remarks:
, please refer to "Rationale for reliability incl. deficiencies" above
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Cobalt aluminate blue spinel
EC Number:
310-193-6
EC Name:
Cobalt aluminate blue spinel
Cas Number:
1345-16-0
Molecular formula:
Co(x)Al(3-x)O4 1≤x≤1,5
IUPAC Name:
Cobalt aluminium spinel
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Blue 214 - Cobalt Aluminate
- Physical state: royal blue coloured powder
- Storage condition of test material: stored at room temperature throughout the study in a large plastic clear jar with a black taped black lid.
No further information on the test material was stated.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 222 to 255 grams
- Fasting period before study: overnight prior to dosing food was denied.
- Housing: the rats were housed in groups of five in stainless steel wire mesh suspension cages.
- Diet (ad libitum, except during the fasting period prior to dosing): animals were maintained on PURINA LABORATORY CHOW
- Water (ad libitum): tap water
- Acclimation period: at least four days prior to dosing

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
DOSAGE PREPARATION: the test material was administered as a 50 % w/v formulation in distilled water.
Doses:
10000 mg/kg
No. of animals per sex per dose:
10 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for gross signs of systemic toxicity and mortality several times during the day of dosing and once daily thereafter for 14 days.
- Necropsy of survivors performed: yes; at the end of the observation period, the rats were weighed, killed by carbon dioxide inhalation and given a gross necropsy.
Statistics:
not applicable

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the obervation period.
Clinical signs:
other: Clinical changes observed during the observation period are as follows: 1. Mild depression 2. Faecal stains 3. Blue sample-like stains on coats 4. Blue mucoid faeces on cage paper 5. Blue-sample-like stains on fur
Gross pathology:
Gross necropsies performed at the end of the study revealed no gross pathological changes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (male rats) > 10000 mg/kg
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.