Registration Dossier

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 Minor deviations from the guideline: - the lot/batch no. was missing. - the humidity (80%) was slightly higher than 70 %. - 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. - age and source of the animals were not stated. - details of food and water quality (including type/source, water source) were missing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 1996-03-22
Deviations:
yes
Remarks:
, please refer to "Rationale for reliability incl. deficiencies" above
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc iron chromite brown spinel
EC Number:
269-050-0
EC Name:
Zinc iron chromite brown spinel
Cas Number:
68186-88-9
Molecular formula:
(Zn,Fe)(Fe,Cr)2O4
IUPAC Name:
zinc iron chromite brown spinel
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): MARRÓN- B5

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS - Sprague-Dawley rats (CFY)
- Age at study initiation: young and healthy
- Weight at study initiation: males: 128 g - 137 g; females: 119 g - 120 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 27X 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 were 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 during which modifications were observed and noted, among other: 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 daily for 14 days.
The observed signs of toxicity were observed at the moment of appearance and also the time of recovery.
- Necropsy of survivors performed: yes; after the study, the 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 were noted for each animal.
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.