Reaction mass of cobalt olivine and crystalline silicon dioxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-02-16 to 2012-03-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001-12-17

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2009-11-12

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of cobalt olivine and crystalline silicon dioxide

EC Number:

701-439-7

Molecular formula:

Co2SiO4∙xSiO2 (0,7≤x≤1,5)

IUPAC Name:

Reaction mass of cobalt olivine and crystalline silicon dioxide

Test material form:

solid: particulate/powder

Details on test material:

- Test item identification: Olivine, cobalt silicate blue (Pigment blue 73)
- new chemical name: Reaction mass of cobalt olivine and crystalline silicon dioxide
- Substance type: inorganic pigment
- Storage conditions: Keep dry and container tightly closed. Keep container in an adequately ventilated storage

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, Research Models and Services, Germany GmbH, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 165 - 181 g
- Fasting period before study: feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum. Food was offered again 3 hours after administration.
- Housing: granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages.
- Diet (ad libitum, except for fasting period (see above)): ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany); animals were kept in groups of 3 animals in MAKROLON cages (type III plus)
- Water (ad libitum): drinking water
- Acclimation period: at least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C (maximum range)
- Relative humidity: 55% ± 15% (maximum range)
- Air changes: 12 to 18-fold air change per hour.
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.8% aqueous hydroxypropylmethylcellulose

Details on oral exposure:

VEHICLE
- Supplier: Fagron GmbH & Co., 22885 Barsbüttel, Germany
- Batch no.: 11 A 27-N27

MAXIMUM DOSE VOLUME APPLIED: the administration volume was 10 mL/kg b.w.

DOSAGE PREPARATION: Olivine, cobalt silicate blue was suspended to the appropriate concentration in 0.8% aqueous hydroxypropylmethylcellulose.

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

6 female animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days. During the follow-up period of two weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on deaths were made at least once daily to minimize loss of animals during the study. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
- Necropsy of survivors performed: yes, at the end of the experiments, all animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded.

Statistics:

No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death was recorded within the test period.

Clinical signs:

other: A single oral administration of 2000 mg Olivine, cobalt silicate blue/kg b.w. did not reveal any signs of toxicity.

Gross pathology:

No pathological changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (female rats) > 2000 mg/kg b.w.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.