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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
From 2021-10-04 to 2021-10-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001-12-17
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
GLP certificate signed 2019-11-29.
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Cobalt zinc aluminate blue spinel
EC Number:
269-049-5
EC Name:
Cobalt zinc aluminate blue spinel
Cas Number:
68186-87-8
Molecular formula:
Co(x)Zn(1-x)Al2O4 0,1≤x≤0,9
IUPAC Name:
Cobalt zinc aluminium spinel
Test material form:
solid: particulate/powder
Details on test material:
- Chemical description: Cobalt zinc aluminate blue spinel
- Physical state: Solid, blue powder, odourless
- Structure: spinel
- Storage condition of test material: Kept dry in closed containers
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature and keep dry in closed containers

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl: WI(Han)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 9 weeks old
- Weight at study initiation: 149 - 154 g
- Fasting period before study: 17 - 18 hours
- Housing: animals were kept in groups of three animals in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding.
- Diet (ad libitum): Altromin 1324 maintenance diet for rats and mice
- Water (ad libitum): tap water, sulphur acidified to a pH value of approximately 2.8.
- Acclimation period: animal no. 1 6 days; animals no. 2 and no. 3: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10 times
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
sterile
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2.5 g/5 mL
- Justification for choice of vehicle: based on the outcome of the solubility test. The vehicle was chosen due to its non-toxic characteristics.
- Lot no.: 2005066

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION:
The test item was suspended with the vehicle. Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before each dose administration.

CLASS METHOD:
- Rationale for the selection of the starting dose: a dose of 5000 mg/kg bw has been selected for the following reasons: the study will be used for EU countries implementing the CLP regulation as well as for non-EU countries implementing the GHS regulation. Furthermore, the test item shows a low water solubility. As the bioavailability (and thus solubility) of the test item is a key determinant of toxicity, low toxicity is expected, therefore justifying an initial testing at the limit dose of 5000 mg/kg bw.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: a careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
Observations on mortality/morbidity were made at least once daily.
Animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were sacrificed, and all animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In the absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation.
Statistics:
No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).

Results and discussion

Preliminary study:
no
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Test item showed no mortality after a single dose administration at a dosage of 5000 mg/kg bw.
Clinical signs:
other:
Body weight:
other body weight observations
Remarks:
None of the animals showed weight loss during the observation period. Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain.
Gross pathology:
No specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (female rats) > 5000 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.