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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study reliable without restrictions - the lot/batch no. of the test material was missing. - the age and source of the animals were not stated. - the relative humidity was slightly (80%) higher than requested by the guideline. - after treatment of one sex, the other sex should not be treated until one is confident of survival of the previously dosed animals. In this study males and females were treated on the same day. -details of food and water quality (including diet type/source) were missing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
, please refer to "Rationale for reliability inc. deficiencies" above
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Nickel iron chromite black spinel
EC Number:
275-738-1
EC Name:
Nickel iron chromite black spinel
Cas Number:
71631-15-7
Molecular formula:
(Ni,Fe)(Fe,Cr)2O4
IUPAC Name:
Nickel iron chromite black spinel
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): NEGRO-G19

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: young and healthy
- Weight at study initiation: males: 134 g - 144 g; females: 117 g - 123 g
- Fasting period before study: animals fasten during the previous night; after 3 hours of administration, feeding was restored
- Housing: groups of three; Makrolon cages (48 X 27 X 20 cm), brand Tecniplast, with wooden bedding; cleaning: by means of changing wooden bedding
- Diet (ad libitum): diet for experimental rats, provided by an authorized provider
- Water (ad libitum): tap water
- Acclimation period: 7 days

At arrival at the Unit, rats went through a health control.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C (+/- 2°C)
- Relative humidity: 55 % (+/- 25 %)
- Air: renewed 15 times per hour and prefiltered at 5 µm
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2 mL of the diluted sample per 100 grams of alive weight

DOSAGE PREPARATION: 2000 mg of sample are diluted in 20 mL of distilled apirogenic water. Sample was vigorously stirred before administration.

CLASS METHOD
- Rationale for the selection of the starting dose: the available information suggested that the sample is little toxic and the limit test was performed.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 males / 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual weight control was performed at the beginning of the study, before administration, after 7 days of administration and at the end of the study or in case of death, right after death. A general clinical examination was performed every working day in which modifications were observed and noted, among others: skin, hair, eyes, mucosity, respiratory track, circulatory system, central and autonomous nervous system, motion activity and behavioural lines of action.With special care for: shaking, convulsions, salivation, diarrhea, lethargy, sleep and coma.
During the first day regular observations were performed and the following days the animals were observed at least once until Day 14.
The observed signs of toxicity were observed, at the moment of appearance and also the time of recovery.
- Necropsy of survivors performed: yes; surviving animals were sacrificed by means of a humanitarian method (cervical dislocation); All the animals in the study were subject to macroscopic necropsy. Macroscopic pathology changes for each animal were noted.
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived until the end of the 14 days of observation.
Clinical signs:
Neither abnormal effects nor any toxicity signs that could be attributed to the sample were observed.
Body weight:
The registered weight variations can be regarded as normal for these animals.
Gross pathology:
There were no relevant macroscopic changes observed in any of the animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (male and female rats) > 2000 mg/kg bw
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the oral route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.