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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline, some restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Test material was applied to the skin of three male and three female rabbits on two sites (one abraded, one unabraded) for 24 hours. Thirty minutes after removal and at 72 hours, dermal irritation was assessed (Draize score).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Sample number: 41105731

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver PA
- Age at study initiation: approximately 14 weeks of age
- Housing: individually in screen-bottom cages
- Diet: ad libitum, Teklad Laboratory Rabbit diet
- Water: ad libitum
- Acclimation period: at least 7 days

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and unabraded (hair was clipped)
Vehicle:
other: test material was moistened with 0.9% saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per site, 2 sites per animal
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3 males, 3 females
Details on study design:
TEST SITE
- Just before the test material was applied, crisscross epidermal abrasions were made on one exposed area of each rabbit to provide one abraded and one intact test site. (Abrasions were sufficiently deep to penetrate the stratum corneum, but not deep enough to penetrate to the dermal layer and cause bleeding).
- Type of wrap if used: 5.0 x 5.0 cm gauze patch secured wtih paper tape and overwrapped with Saran Wrap and Elastoplast tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test sites washed with tap water and disposable paper towels
- Time after start of exposure: 24 hours

SCORING SYSTEM: at 24 hours and 72 hours, according to Draize technique. Primary dermal irritation index: the sum of the 24 and 72-hour primary dermal irritation scores, divided by two and rounded to the nearest tenth.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hrs
Score:
0.2
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hrs
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 hrs
Score:
0
Max. score:
4
Remarks on result:
other: intact site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 hrs
Score:
0
Max. score:
4
Remarks on result:
other: intact site
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 hrs
Score:
0.08
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: abraded site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 hrs
Score:
0.08
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: abraded site
Irritant / corrosive response data:
The test material is not a primary skin irritant.

Applicant's summary and conclusion

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

The primary skin irritation/corrosion of multiconstituent aluminium potassium fluoride in the rabbit was investigated in a non-guideline study. Despite some restrictions in design and/or reporting, the study is considered as adequate for assessment. Three male and three female rabbits were exposed to 0.5 grams of multiconstituent aluminium potassium fluoride. The test material was applied to two test sites (one abraded and one intact) on each rabbit for 24 hours using an occlusive dressing. After the exposure period, the patches were removed and the test sites were washed with tap water. Observations were made 30 minutes following removal and at 72 hours. No skin irritation was caused by 24 hours to multiconsituent aluminium potassium fluoride. Based on the results of the study, multiconsituent aluminium potassium fluoride is considered to be not irritating to skin