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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:
From 07 July 1998 (Start of in-life phase) to 30 September 1998 (GLP compliance statement)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reference substance 001
EC Number:
604-086-6
Cas Number:
138577-01-2
Molecular formula:
Al.Cs.F
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material: Cesium Fluoro Aluminate Complex
- Purity: 99.5%
- Batch: 604/013
- Physical state: White amorphous powder
- Storage condition of test material: At room temperature in the dark
- Expiration date of the lot/batch: 22 May 2001

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 7 weeks old
- Weight at study initiation: body weights were less than 1.5 kg
At least prior to dosing, it was ensured that the animals were healthy and that the skin to be treated was intact and free from any abnormality.
- Housing: Animals were individually housed in labeled cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 grams per day. In addition, hay (BMI, Helmond, The Netherlands) was provided once a week.
- Water : Free access to tap water diluted with decalcified water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature: controlled at 21°C
- Humidity: controlled at 50 %
- Air changes : approximately 15 room air changes/hour
- Photoperiod : 12-hour light/12-hour dark cycle
Fluctuations from these optimal conditions were noted, but were considered as not to have affected study integrity.

IN-LIFE DATES: From: 7 to 10 July 1998.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
Amount(s) applied : Each animal was treated by dermal application of 0.5 grams of the test substance which was moistened with the vehicle (i.e. water).

VEHICLE
The powdery test substance was moistened with water (Milli-U), immediately before application, to ensure close contact with the animal's skin.
No corrections were made for the purity/composition of the test substance, since the guidelines requires a fixed amount that has to be applied.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males.
Details on study design:
TEST SITE
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm2). Whenever considered necessary the treated skin areas were reclipped at least 3 hours before the observations, to facilitate the scoring. The test item was applied to the skin of one flank, using a Scotchpak-non-woven patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using a tissue moistened with tap water and subsequently a dry tissue.

OBSERVATION AND SCORING SYSTEM:
Mortality/Viability: observation twice daily.
Toxicity: observation at least once daily.
Body Weight: day of treatment (prior to application).
Necropsy: No necropsy was performed according to protocol.
Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:

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) *......................................................................................................4
*. Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the
maximum grade for erythema (= 4) is given.

Oedema formation:
No oedema .............................................................................................................................................0
Very slight oedema (barely perceptible) ............................................................................................1
Slight oedema (edges of area well-defined by definite raising) .....................................................2
Moderate oedema (raised approximately 1 millimeter) ...................................................................3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Irritation: No skin irritation was caused by 4 hours exposure to cesium fluoro aluminate complex
Corrosion: There was no evidence of a corrosive effect on the skin.
Coloration / Remnants: No staining of the treated skin by the test substance was observed.
Toxicity / Mortality : No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Other effects:
No histopathology was performed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the study, cesium aluminium fluoride – complex is considered to be not irritating to skin.
Executive summary:

The primary skin irritation/corrosion of Cesium aluminium fluoride - complex in the rabbit (4-hour semi-occlusive application) was investigated in a study performed according to the OECD Testing Guideline No. 404 and under GLP. Three rabbits were exposed to 0.5 grams of cesium fluoro aluminate complex, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure. No skin irritation was observed after 4 hours exposure to cesium fluoro aluminate complex. Based on the results of the study, cesium fluoro aluminate complex is considered to be not irritating to skin.