Chromium tin calcium silicon sphene

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987-02-24

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chromium tin calcium silicon sphene

EC Number:

701-417-7

Cas Number:

68187-12-2

Molecular formula:

Ca(x)Cr(y)Sn(1-y)SiO5 0,7≤x≤1,0 0

IUPAC Name:

Chromium tin calcium silicon sphene

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material: Sicocer F Pink 10 310
- OLD EC name: Chrome tin pink sphene
- NEW EC name: Chromium tin calcium silicon sphene
- Physical state: solid; powder, pink
- Stability in water: insoluble and therefore stable in water
- Storage condition of test material: room temperature
- Homogeneity: the sample appeared to be homogenous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS - Wistar rats (CHBB: THOM (SPF))
- Age at study initiation: young adults animals
- Weight at study initiation: males: 195 - 200 grams; females: 187 - 192 grams
- Fasting period before study: the animals were given no feed at least 16 hours before administration, but water was available ad libitum.
- Housing: stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG); single housing; no bedding in the cages; sawdust in the waste trays
- Diet (ad libitum, except for fasting period before test item administration): Kliba-Labordiaet 343, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS - the animals were housed in fully air-conditioned rooms.
- Temperature: 20 -24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: Aqua bidest. was chosen since an aqueous formulation corresponds to the physiological medium.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSE CONCENTRATION: 22.000 g/100 mL

DOSAGE PREPARATION: Form of administration was a suspension.

Doses:

2200 mg/kg

No. of animals per sex per dose:

5 males / 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Body weight determination: individual body weights shortly before application (Day 0), weekly thereafter and at the end of the study (before fasting period).
- Signs and symptoms: recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
- General observation and mortality: a check was made twice each workday and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.
- Necropsy of survivors performed: yes; necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy with gross-pathology examination. Necropsy of all animals that died before as early as possible.

Statistics:

not applicable

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 200 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: No abnormalities were observed at the cageside observations.

Gross pathology:

No pathologic findings noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (male and female rats) > 2200 mg/kg
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.