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Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-09-01 to 1987-09-15
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Comparable to guideline study reliable with restrictions - the purity of the test material was missing in the study report. Minor deviations from the guideline: - in this study only males were given the test item. According to the guideline, after completion of the study in one sex one group of the other sex is dosed to establish that animals of this sex are not markedly more sensitive to the test substance. Where adequate information is available to demonstrate that the animals of the sex tested are markedly more sensitive, testing in animals of the other sex may be dispensed with. If males are more sensitive to the test item than females was not stated in the report, but since the LD50 for males lies above 10000 mg/kg it is assumed that the LD50 for the females is also above 2000 mg/kg and no testing of females is needed. - the acclimatisation period in this study was four days - the age of the rats was missing in the study report. Since the weight of the rats was about 200 g, it was assumed that the rats were young adults. - the administered test volume was not stated - information on temperature and relative humidity (holding conditions) were missing. - time of appearance and disappearance of clinical signs was not stated. In addition, the number of animals displaying signs of toxicity was not shown. - body weight should be determined at the day of administration and then weekly thereafter and at death. The body weight was determined at the day of administration and at the end of the study (Day 14).

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 1987-02-24
, please refer to "Rationale for reliability incl. deficiencies" above
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Copper chromite black spinel
EC Number:
EC Name:
Copper chromite black spinel
Cas Number:
Molecular formula:
Copper chromite black spinel
Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Black 1- Copper Chromite Lot #X7156
- Physical state: black coloured powder
- Storage condition of test material: stored at room temperature throughout the study in a large clear plastic jar with a black taped black lid.
No further information on the test substance was stated.

Test animals

Details on test animals or test system and environmental conditions:
- Weight at study initiation: 181 to 216 grams on the day of treatment
- Fasting period before study: overnight prior to dosing food was denied
- Housing: the rats were housed in groups of five in stainless steel wire mesh suspension cages.
- Diet (ad libitum, except during the fasting period prior to dosing): animals were maintained on PURINA LABORATORY CHOW
- Water (ad libitum): tap water
- Acclimation period: at least four days prior to dosing

- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test material was stated.

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
DOSAGE PREPARATION: the test material was administered as a 50 % w/v formulation in distilled water.
No further information on the oral exposure was stated.

10000 mg/kg
No. of animals per sex per dose:
10 males
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for gross signs of systemic toxicity and mortality several times during the day of dosing and once daily thereafter for 14 days.
- Necropsy of survivors performed: yes, at the end of the observation period, the rats were weighed, killed by carbon dioxide inhalation and given a gross necropsy.
No further information on the study design was stated.
not applicable

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
No deaths occurred during the observation period.
Clinical signs:
other: Clinical changes observed during the observation period are as follows: 1. Mild depression 2. Faecal stains and loose mucoid faeces on cage paper
Gross pathology:
Gross necropsies performed at the end of the study revealed no gross pathological changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
LD50 (male rats) > 10000 mg/kg
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.