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Toxicological information

Skin irritation / corrosion

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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:
1993
Bibliographic source:
Int. J. Toxicol., 12(6): 632

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: FHSA 16 CFR 1500.41
Principles of method if other than guideline:
no data
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.