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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Mar - 13 Apr 2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions: it should be noted that the test substance is not soluble in water.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Secrétariat général du Groupe Interministeriel Des Produits Chimiques - DGCIS-SI - 12, rue Villiot, 75572 Paris cedex 12, France
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Aluminum cobalt oxide
EC Number:
235-762-5
EC Name:
Aluminum cobalt oxide
Cas Number:
12672-27-4
Molecular formula:
Co2Al2.6O4.8 corresponding to two crystalline phases: CoAl2O4 (35%) and Al2Co2O5 (65%)
IUPAC Name:
dialuminum; cobalt(2+); oxygen(2-)
Details on test material:
- Name of test material (as cited in study report): cobalt aluminium oxide
- Physical state: powder (blue)
- Analytical purity: > 99%
- Batch No.: EH 110006/1
- Expiration date of the lot/batch: June 2013
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 181 - 215 g
- Fasting period before study: Food was removed at D-1 and then redistributed 4 h after test item administration
- Housing: by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid; each cage contains sawdust bedding which was changed at least 2 times a week; each cage was installed in conventional air conditioned animal husbandry.
- Diet: ad libitum; M20-rat/mouse maintenance (made from the formulation EXTRALABO from PIETREMENT)
- Water: ad libitum; tap water from public distribution system (microbiological and chemical analyses carried out every six months by the IPL, Santé, Environnement Durables - Atlantique)
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw

DOSAGE PREPARATION:
In the first and second steps of the study, 2000 mg of the test item was weighed and distilled water was added to 10 mL volumetric flask. The preparation was magnetically stirred to obtain a blue solution, just before the administration.

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations were carried out daily; body weights were determined on D0 (just before administering the test substance), D2, D7 and D14
- Necropsy of survivors performed: yes
- Necropsy examinations: oesophagus, stomach, duodenum, jejunum, ileon, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, ovaries, uterus, adrenals, pancreas

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off according to OECD 423
Mortality:
2000 mg/kg bw dose group: no mortality occurred during the study.
Clinical signs:
other: 2000 mg/kg bw dose group: No clinical signs related to the administration of the test item were observed.
Gross pathology:
2000 mg/kg bw dose group: The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Any other information on results incl. tables

Table 1 

Dose
[mg/kg bw]

Toxicological results*

Duration of clinical signs

Time of death

Mortality (%)

Females

2000

0/0/6

---

---

0

LD50 = 5000 mg/kg bw (LD50 cut-off according to OECD 423)

* first number = number of dead animals                                   

 second number = number of animals with clinical signs           

 third number = number of animals used                                 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified