Cobalt lithium dioxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-08-19 to 2009-09-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Guideline study reliable without restrictions - According to the guideline, a rational for the initial dose level selection and any data used to support this chioce should be provided. - According to the guideline the source of the diet should be stated. This is missing in the study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Version / remarks:

2006-03-23

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cobalt lithium dioxide

EC Number:

235-362-0

EC Name:

Cobalt lithium dioxide

Cas Number:

12190-79-3

Molecular formula:

CoO2.Li

IUPAC Name:

cobalt(3+) lithium(1+) dioxidandiide

Details on test material:

- Name of test material (as cited in study report): Lithium Cobalt Dioxide
- Physical state: Blue-black powder
- Analytical purity: > 99 % (calculated based on the impurity levels given below)
- Impurities : Nickel 0.031 %; Iron 0.004 %; Silicon 0.008 %; Sodium 0.006 %; Calcium 0.015% and Water 0.006 %
- Lot No.: 30060
- Estimated expiration date of the lot: 2016-02-02
- Stability: Test substance was expected to be stable for the duration of testing.
- Storage condition of test material: At room temperature
- Solubility: Soluble in water (304 µg/L based on OECD TG 105 at 37 °C)
No further information on the test material was stated.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 168 - 200 g
- Fasting period before study: Rats were fasted overnight. Feed was replaced approximately 3 - 4 hours after dosing.
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors, which conform to the size recommendations in the most recent Guide for the CAre and Use of LAboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet: Purina Rodent Chow #5012
- Water (ad libitum): Filtered tap water
- Acclimation period: 8 or 22 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 24 °C
- Relative humidity: 58 - 78 %; Humidity was above targeted upper limit for seven days during the study. A portable dehumidifier was used to lower the humidity levels during this time.
- 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:

VEHICLE
The test substance was administered as a 55 % w/w mixture in distilled water.
-Dose calculation: Individual doses were calculated based on the initial body weight, taking into account the specific gravity of 1.800 g/ml (determined by EPSL) of the test substance.
No further information on the oral exposure was stated.

Doses:

5000 mg/kg

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination) following dosing. The animals were observed for mortality, signs of gross toxicity, and behavioural changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing.
- Necropsy of survivors performed: Yes
All rats were euthanized via CO2 inhalation at the end of the 14-day observation period. gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.
- Other examinations performed: Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observation or tremors, convulsions, salivation, diarrhea, and coma.
No further information on the study design was stated.

Statistics:

No data

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived.

Clinical signs:

other: All animals appeared active and healthy during the study. there were no signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour.

Gross pathology:

No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute oral LD50 of Lithium Cobalt Dioxide is greater than 5000 mg/kg of body weight in female rats.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified.