Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19-22 November 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Proprietary, GLP and guideline-compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Calcium fluoride (CaF2), a white powder, stored at ambient temperature.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The animals were young adult female SPF bred New Zealand White albino rabbits, obtained from Centre Lagro, France. They underwent 12 days quarantine/acclimatisation prior to the study commencing. The rabbits weighed between 1924 and 1985 g at study initiation. Rabbits were housed individually in stainless steel cages, and were identified by ear marks. The rabbits were subject to a 12 hour light/dark cycle, and the temperature during testing was 20±3°C, with approximately 10 air changes per hour. Humidity ranged from 45-99.9%; the upper limit was higher than 70% due to wet cleaning of the animal room and/or meteorological circumstances. The rabbits were fed standard laboratory rabbits diet ad libitum (SDS Special Diets services, England). Tap water was also available ad libitum. Upon arrival the rabbits were checked for overt signs of ill health and anomalies.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g of CaF2 moistened with 0.5 ml water.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
Three days prior to the start of the study, the hair was removed from the backs and flanks of the animals using electric clippers. The clipping was repeated if considered necessary. A skin site suitable for application was chosen, then a small cup loaded with 0.5 g of test substance and moistened with 0.5 ml water was placed on the skin. The cup was fixed to the selected application site using adhesive tape. The entire trunk of the rabbit was wrapped with self-adhesive gauze to keep the cup in place and minimise evaporation. The gauze was additionally fastened with two strips of tape. After a 4 hour exposure period, the cups were removed and the test site cleaned with moistened tissue. Approximately 1 hour later the resulting skin reactions were evaluated by the method of Draize. Further skin readings were made at 24, 48 and 72 hours after treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24-72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No skin reactions (i.e. scores of 0 were given for erythema formation and oedema formation) were seen in any of the three rabbits at any time point.
Other effects:
No other effects reported

Any other information on results incl. tables

At 1 -72 hours after treatment, no signs of dermal irritation were observed in any of the three rabbits.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to EC-standards, calcium fluoride is not irritating or corrosive to skin.
Executive summary:

Calcium fluoride was tested for acute dermal irritating properties in three New Zealand White rabbit, according to OECD Guideline 404. The skin was exposed to the test substance for 4 hours under semi-occlusive conditions. At 1 -72 hours after treatment, no signs of dermal irritation were observed in any of the three rabbits. According to EC criteria, calcium fluoride is not irritating or corrosive to skin.