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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

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:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Aluminium fluoride
EC Number:
232-051-1
EC Name:
Aluminium fluoride
Cas Number:
7784-18-1
Molecular formula:
AlF3
IUPAC Name:
aluminum trifluoride
Details on test material:
- Name of test material (as cited in study report): AlF3, Aluminum fluoride
- Physical state: dry solid, white powder
- Lot/batch No.: XP01_00008_01
- Storage condition of test material: room temperature, in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Stolzenseeweg 32-36, D-88353 Kisselegg, Germany
- Age at study initiation: not reported
- Weight at study initiation: 3.5-3.8 kg
- Housing: individually in PPO-plast cages (Noryl®, floor area: 2576 cm²) with perforated floor
- Diet (e.g. ad libitum): pelleted complete rabbit diet "Altromin 2123 " from Chr. Petersen A/S, DK-4100 Ringsted ad libitum
- Water (e.g. ad libitum): domestic quality water acidified with HCl to pH 2.5 in order to prevent microbial growth ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 10 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
other: 0.9% NaCl
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 mL vehicle


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
Skin reactions read 1, 24, 48, and 72 hours after patches were removed
Number of animals:
3 females
Details on study design:
The day before start of the experiment (day -1) the rabbits were weighed and an area of 10 x 15 cm on the back was clipped as closely as possible with an electric clipper. On the first experimental day (day 1) the rabbits were physically restrained on a test table, and the clipped area was divided into four fields. The two anterior test sites were used for testing the experimental preparation. To each test field (2.5 x 2.5 cm) 0.5 g of the test article moistened with 0.5 mL sterile 0.9% NaCl was applied. Gauze patches (2.5 x 2.5 cm) were placed on each test field. The gauze patches were secured with 2.5-cm wide adhesive tape and fixed with Scanpor tape (5-cm width). Thereafter Nobafix (6-cm width) was loosely wound around the trunk. After an exposure time of 4 hours, the tape and patches were removed and the treated skin was cleaned with lukewarm water and mild soap (Deo-Tvgl, Biokema, Goteborg). The skin reactions were read 1 hour later. Readings were also made 24, 48, and 72 hours after termination of exposure.

The scores for erythema and oedema formation for the 3 readings at 24, 48, and 72 hours for each rabbit were obtained separately and divided by 6. The results are the mean scores for erythema and oedema formation for the individual rabbit. The mean scores for erythema and oedema formation in all 3 rabbits were subsequently calculated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritant / corrosive response data:
The mean individual erythema scores were 0.0 for all three rabbits. The mean individual oedema scores were 0.0 for all three rabbits. The mean score for the test article was 0.0 for erythema and 0.0 for oedema.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: other: CLP (EC 1272/2008)