Cobalt, borate neodecanoate complexes

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-07-21 to 2007-03-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Minor deviations with no effect on the study results- The stability of the test material was missing, but it was stated in the report that the test substance appeared to be stable under the conditions of the study. No evidence of instability, such as a change in colour or physical state, was observed.- According to the guideline, the volume for administration of the test substance should not normally exceed 1 ml /100g of body weight; however in the case of aqueous solution, 2 ml/100 g body weight can be considered. Also, the test substances should be administered in a constant volume. The test substance was not administered in a constant volume and the volume for nonaqueous solutions was exceeded. This was not considered to influence the results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

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:

yes

Remarks:

, see "rational for reliability"

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cobalt, borate neodecanoate complexes

EC Number:

270-601-2

EC Name:

Cobalt, borate neodecanoate complexes

Cas Number:

68457-13-6

Molecular formula:

Cobalt, borate neodecanoate complexes

IUPAC Name:

Cobalt, borate neodecanoate complexes

Details on test material:

- Name of test material (as cited in study report): Cobalt borate neodecanoate- Physical state: Viscous liquid- Analytical purity: see composition of test material- Composition of test material, percentage of components: > 94 % Cobalt borate neodecanoate; < 6 % Cobalt borate propionate; 22.15 % Cobalt- Batch No.: A469 - Stability under test conditions: The test substance appeared to be stable under the conditions of the study. No evidence of instability, such as a change in colour or physical state, was observed. - Density: 1.32 g/cm^3 at 25 °C- Water solubility: 51.2 mg/L at 20 °C- pKa: 6.41 at 20 °CNo further information on the test material was stated.

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Charles River LAboratories, Inc., Raleigh, North Carolina, U.S.A.- Age at study initiation: approx. 10 or 11 weeks old- Weight at study initiation: 205.0 to 235.2 g- Fasting period before study: Approx. 16 - 18 hours prior to dosing, with food being returned to the rats approx. 3 -4 hours after dosing- Housing: All animals were housed singly in stainless steel, wire-mesh cages suspended above cage boards.- Diet (ad libitum): PMI ® Nutrition International, LLC Certified Rodent Lab Diet® 5002- Water: ad libitum- Quarantine period: at least 6 days ENVIRONMENTAL CONDITIONS- Temperature: 18 -26 °C - Relative humidity: 30 - 70 % - Photoperiod (hrs dark / hrs light): 12/12No further information on the test animals was stated.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE & DOSAGE PREPARATIONThe test substance would not suspend in an aqueous vehicle. An acceptable solution was obtained using corn oil as vehicle. Cobalt borate neodecanoate was mixed with Mazola® corn oil, sonicated at approx. 45°C for several hours, and stirred overnight to solubilize. A new dose solution was prepared for each day of dosing.MAXIMUM DOSE VOLUME APPLIED: Individual dose volumes were calculated using the fasted body weights obtained prior to dosing. The rats dosed at 175 or 550 mg/kg were dosed at a volume of 10 mL per kg of body weight. the rats dosed at 2000 mg/kg were dosed at 20 mL per kg of body weight because the dose solutions at concentrations above 100 mg/mL were too thick to administer. The amount given to the rats dosed at 2000 mg/kg were administered in two portions, 15 or 19 minutes apart. the dosing solutions were stirred for at least 30 minutes prior to and throughout the dosing procedure.- Rationale for the selection of the starting dose:The starting dose level of 175 mg/kg was chosen based on the absence of toxicity data for this test substance.No further information on the oral exposure was stated.

Doses:

175 mg/kg, 550 mg/kg, 2000 mg/kg

No. of animals per sex per dose:

175 mg/kg: one female550 mg/kg: three females2000 mg/kg: three females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days (or other?)- Frequency of observations and weighing: Observations for mortality and signs of illness, injury, or abnormal behaviour were made daily throughout the study. Rats were observed for clinical signs at the beginning of fasting, just before dosing (test day 0), once during the first 30 minutes after dosing and 2 more times on the day of dosing, and once each day thereafter. Rats were weighed on the test days-1, 0, 7, and 14. Test day -1 is prior to fasting and test day 0 is after fasting. - Necropsy of survivors performed: YesOn test day 14, the surviving rats were euthanized and necropsied to detect grossly observable evidence of organ or tissue damage or dysfunction. the rats were anesthetized by carbon dioxide and euthanized by exsanguination. the rats that died were also necropsied.No further information on the study design was stated.

Statistics:

A softeware package (A0T425StatPgm) was used to determine the dose progression and to calculate the LD50.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

approximate LD50

Effect level:

1 098 mg/kg bw

Based on:

test mat.

95% CL:

>= 550 - <= 2 000

Remarks on result:

other: Approx. LD50 based on an assumed sigma of 0.5; The 95% CL is an approx. 95% confidence interval

Mortality:

The rats dosed at 2000 mg/kg were found dead 1, 3, or 4 days after dosing. All other animals surivied until sacrification.

Clinical signs:

other: No clinical signs of toxicity were observed in the rat dosed at 175 mg/kg. All rats dosed at 550 mg/kg or 2000 mg/kg exhibited clinical signs including various staining, wet fur, high carriage,diarrhea, lethargy, ataxia, clear ocular discharge, labored br

Gross pathology:

There were no test substance-related gross lesions found in the study. The only gross lesion observed, skin stain in two rats, was non-specific and not indicative of target organ toxicity.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of this study, the oral LD50 for cobalt borate neodecanoate was 1098 mg/kg for female rats.
According to the EC Regulation No. 1272/2008 and subsequent regulations, cobalt borate neodecanoate is classified Category 4.