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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant OECD Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
BETA-CYCLOOEXTRIN (KLEPTOSE®),

Test animals

Species:
rabbit
Strain:
other: albino (no further details reported)
Details on test animals and environmental conditions:
Species: rabbit
Strain: albino
Origin: VASSEUR, PROUZEL. FRANCE
Sex: males
Weight: 2.0 kg - 3.0 kg
Number :6/group

Housing: individual stainless steel cage. wire-floor size 61 x 48 x 37 cm
Feed: SANDERS / LAPIPLUS - ROBENZ
Beverage: drinking water, automatic drinking bowl
Environment:
temperature 20° C +/- 1
hygrometry 50 %+/- 10
artificial lighting 12 hrs/day
air renewal 12 times/hr

The animals were housed for at least one week before the beginning of the experiment.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: yes, untreated area of animal
Amount / concentration applied:
0.5 g of solid substance, on each flank
Duration of treatment / exposure:
23 hr
Observation period:
up to 14 days
Number of animals:
6
Details on study design:
About 24 hrs prior to the study, the six rabbits were clipped with a fine-tooth electric clipper to bare a skin surface of 14 cm x 14 cm (cutting
height = 1/20th mm); thus a precise cut can be achieved without irritating the skin mechanically. The animals were left to rest for 24 hours; then only those with a perfectly healthy skin were chosen for the test.
Three incisions of about 2 cm long, 0.5 cm apart, were made into the right flank of each rabbit, parallel to the vertebral axis, by means of a sterile
vaccinostyle. The incisions were made so as to attack the epidermis without reaching the dermis. Any bleeding has to be avoided, and in any case, the
underlying muscle must not appear.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: none
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0.5
Reversibility:
fully reversible
Remarks on result:
other: none
Irritant / corrosive response data:
The figures for erythema and oedema obtained 1 hr. 24 and 48 hrs after removal of the dressings on both flanks were added for the 6 rabbits; then the index of primary cutaneous irritation (Pci) was calculated by dividing the total by the number of data
The results were interpreted according to the following scale:

less than 0.5 non irritant
from 0.5 up to 2 slightly irritant
from 2 up to 5 moderately irritant
from 5 up to 8 severely irritant
Other effects:
none reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Beta-Cyclodextrine showed practically no irritating potential when applied to the skin of rabbits.
Executive summary:

In a skin irrtation assay with beta-Cyclodextrin (purity 100%) according to OECD Guideline 404 on 6 albino rabbits 0.5 g of the substance was administered to the clipped and shaved skin. A primary cutaneous irritation scheme ranging from 0 to 8 was used. The substance was left under occlusive conditions for 23 h. The skin was then observed after 1, 24 and 48 hr, showing an edema score of 0 and also an erythema score of 0 for all animals at all observation times. Only one animal exhibited a erythema score of 0.5 at the 24 h observation interval. The erythema score of this animal returned to 0 after 48 hr and showed full reversibility. Under the conditions used beta Cyclodextrin has to be clssified as not irritant to the skin of rabbits.