Dicerium tricarbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

data not available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The test is presented in a short summary. However, the information necessary for the assessment are given, and the test conditions are in accordance with those of the recognised EC or OECD guidelines. In order to limit vertebrate animal testing as far as possible, no other test has been performed. In addition, similar results were observed on analogues (other rare earth carbonates).

Data source

Reference

Reference Type:

publication

Title:

Acute toxicological evaluation of cerium carbonate

Author:

Lambert CE, Barnum EC, Shapiro R

Year:

1993

Bibliographic source:

J Am Coll Toxicol, 12(6), 631

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: similar to 16CFR 1500-41

Deviations:

not specified

Principles of method if other than guideline:

other: unknown

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Cerium carbonate (CAS 5853-16-7), hydrated form.

IUPAC Name:

Cerium carbonate (CAS 5853-16-7), hydrated form.

Details on test material:

- Test material identity: Cerium carbonate (CAS 5853-16-7)
- Molecular formula: C-H2-O3.2/3Ce.5H2-O
- Molecular weight: 730.5 g
- InChI: Carbonic acid, cerium(3+) salt (3:2), pentadecahydrate
- Analytical purity: data not available
- Impurities: data not available
- Lot/batch No: data not available
- Expiration date of the lot/batch: data not available
- Stability under test conditions: data not available
- Storage condition of test material: data not available

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Source, Age at study initiation, Weight at study initiation, Housing, Diet, Water, Acclimation period: data not available

ENVIRONMENTAL CONDITIONS:
- Temperature, Humidity, Air changes, Photoperiod: data not available

IN-LIFE DATES: data not available

Test system

Type of coverage:

occlusive

Preparation of test site:

other: one intact and one abraded skin site

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

24 hour(s)

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE:
- Area of exposure: ca. 2.5 cm²
- % coverage: data not available
- Type of wrap if used: data not available

REMOVAL OF TEST SUBSTANCE:
- Washing: yes (the sites were wiped)
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

8

Reversibility:

other: not relevant because no effet

Irritant / corrosive response data:

There were no signs of dermal irritation. Cerium carbonate is not considered to be a skin irritant.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In this study, cerium carbonate is not a dermal irritant.

Executive summary:

In a primary dermal irritation study (Lambert CE et al, 1993), 6 New Zealand Albino rabbits were dermally exposed to 0.5 g of cerium carbonate (purity unknown) for 24 hours to ca. 2.5 cm² of one intact and one abraded skin site. Test sites were covered with an occlusive dressing for 24 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize.
 
In this study, cerium carbonate is not a dermal irritant.