Registration Dossier
Registration Dossier
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EC number: 231-841-3 | CAS number: 7758-88-5
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:
- Study conducted in accordance with generally accepted scientific principles, with incomplete reporting or methodological deficiencies. This reference does not provide a full report with regard to the methods used in this study. However, as most basic key information is reported, the study can be judged as scientifically acceptable.
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute Toxicological Evaluation of Cerium Fluoride
- Author:
- Lambert, C.E., Barnum, E.C. and Shapiro, R.
- Year:
- 1 993
- Bibliographic source:
- Int. J. Toxicol., 12(6): 632
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: FHSA 16 CFR 1500.41
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cerium trifluoride
- EC Number:
- 231-841-3
- EC Name:
- Cerium trifluoride
- Cas Number:
- 7758-88-5
- Molecular formula:
- CeF3
- IUPAC Name:
- cerium trifluoride
- Reference substance name:
- Cerium Fluoride
- IUPAC Name:
- Cerium Fluoride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
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:
- undiluted / 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours; the sites were evaluated 24 and 72 hours after the initial exposure.
- 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 test sites were wiped)
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to Draize:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (edges raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 0
- Reversibility:
- no data
- Irritant / corrosive response data:
- There were no signs of dermal irritation.
Any other information on results incl. tables
There were no signs of dermal irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was not irritating under the conditions of this test and is not classified in accordance with EU criteria.
- Executive summary:
In a primary dermal irritation study that broadly followed the FHSA 16 CFR 1500.41 guideline, six New Zealand White rabbits were dermally exposed to 0.5 g of the test material on one intact and one abraded skin site. Test sites were covered with an occlusive dressing for 24 hours and the animals were observed for the following 72 hours. Irritation was scored by the method of Draize 24 and 72 hours after the initial exposure.
There were no signs of dermal irritation and the Primary Dermal Irritation Index = 0.0.
Under the conditions of this study, the test material is not a dermal irritant and does not require classification in accordance with EU criteria.
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