Iron cobalt chromite black spinel

Acute Toxicity: oral

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 Deviations from the guideline: - CAS No. of the test material was not stated. - normally females are used in the test. When the test is conducted in males adequate justification should be provided. - the age of the rats was not given. It was only stated that young adults were used. - the humidity (80%) was slightly higher than 70 %. - the rats were not exposed in a stepwise manner. - animals should be observed individually after dosing at least once during the first 30 minutes, periodically during the first 24 hours, with special attention given during the first 4 hours. In the study report it was only stated that the animals were regular observed during the first day. - details on food and water quality were missing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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 2001-12-17

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

Test material information

Constituent 1

Reference substance name:

Iron cobalt chromite black spinel

EC Number:

269-060-5

EC Name:

Iron cobalt chromite black spinel

Cas Number:

68186-97-0

Molecular formula:

(Co, Fe)(Fe,Cr)2O4

IUPAC Name:

dichromium(3+) diiron(3+) λ²-cobalt(2+) λ²-iron(2+) octaoxidandiide

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): SÓLIDO
No further information on the test material was stated.

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: 140 - 160 g; females: 201 - 209 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
No further information on the test animals was stated.

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 a 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.
No further information on the oral exposure was stated.

Doses:

2000 mg/kg of alive weight

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 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 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.
No further information on the study design was stated.

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:

other: Neither abnormal effects nor any toxicity signs that could be attributed to the sample were observed.

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.