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Diss Factsheets

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:
11 Feb - 11 Mar 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Secrétariat général du groupe interministeriel des produits chimiques, DGE-Simap, 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:
Dialuminium nickel tetraoxide
EC Number:
234-454-8
EC Name:
Dialuminium nickel tetraoxide
Cas Number:
12004-35-2
Molecular formula:
(Ni[1-x]*Alx)(Nix*Al[2-x])O4 with n in a range of 0.6 -0.93
IUPAC Name:
dialuminium(3+) nickel(2+) tetraoxidandiide
Details on test material:
- Name of test material (as cited in study report): Nickel Aluminate
- Physical state: solid, blue powder
- Analytical purity: > 99%
- Lot/batch No.: 19044-36; Identification code number: PH-09/0042
- Expiration date of the lot/batch: Sep 2010
- Storage condition of test material: room temperature
- Production date: Oct 2008

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: 187 - 209 g
- Fasting period before study: 1 day
- Housing: groups of 3, clear polycarbonate cages with sawdust bedding and stainless steel mesh lid
- Diet: M20 rat/mouse maintenance diet, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least five days


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

Administration / exposure

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


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit test according to OECD 423
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: examination daily, weighing on day 0 (prior to administration), then on days 2, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
other: LD50 cut-off
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
other: No test substance-related clinical signs were observed. However, a decrease in spontaneous activity was observed in 1/6 animals at 30 min after test substance administration. The animal recovered a normal behaviour 1 hour after administration.
Gross pathology:
Macroscopical examination of the animals did not reveal treatment-related changes.

Applicant's summary and conclusion