Dicerium tricarbonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 21-MAY-2007 to 21-NOV-2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to EU / OECD guidelines and GLP.

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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dicerium tricarbonate

EC Number:

208-655-6

EC Name:

Dicerium tricarbonate

Cas Number:

537-01-9

Molecular formula:

CH2O3.2/3Ce

IUPAC Name:

dicerium tricarbonate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: 334 ± 7 g for the males and 208 ± 5 g for the females.
- Fasting period before study: data not available
- Housing: housed individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm)
- Diet: free access to SsniffR/M-H pelleted diet (SSNIFF Spezialdiäten GmbH, Soest, Germany)
- Water: drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Humidity: 30 to 70%
- Air changes: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12 h dark/12 h light


IN-LIFE DATES: From: 24-MAY-2007 To: 19-JUN-2007

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area, approximately 5 cm x 7 cm for males and 5 cm x 6 cm for females
- % coverage: approximately 10% of the total body surface of the animals
- Type of wrap if used: gauze pad held in contact by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable


TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
- Concentration (if solution): undiluted (moistened with 2 mL of purified water)
- Constant volume or concentration used: not applicable
- For solids, paste formed: yes


VEHICLE
- Amount(s) applied: not applicable
- Concentration: not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> Clinical signs and mortality: frequently during the hours following administration of the test item. Thereafter, observation of the animals was made at least once a day until day 15.
> Body weight: just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: local irritation

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs and no cutaneous reactions at the treatment site were observed during the study.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Other findings:

no other information

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the dermal LD50 of the test item Cerium carbonate was higher than 2000 mg/kg bw in rats.

Executive summary:

The acute dermal toxicity of the test item Cerium carbonate was evaluated in rats according to OECD (No. 402, 24th February 1987) and EC (92/69/EEC, B.3, 31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

The test item was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females).

The application was performed with the test item in its original form at the dose-level of 2000 mg/kg. Taking into account this purity (76.7%), a correction factor of 1.304 was used.

The test site was then covered by a semi-occlusive dressing for 24 hours.

Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test item. All animals were subjected to necropsy.

No deaths, no clinical signs and no cutaneous reactions at the treatment site were observed during the study. A slightly lower body weight gain was observed in some animals. No apparent abnormalities were observed at necropsy in any animal.

Under the experimental conditions of this study, the dermal LD50 of the test item Cerium carbonate was higher than 2000 mg/kg in rats.