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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
172 hours
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted according to GLP requirements and EU method.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
EEC Directive 79/831
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one
EC Number:
244-240-6
EC Name:
1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one
Cas Number:
21145-77-7
Molecular formula:
C18H26O
IUPAC Name:
1-(3,5,5,6,8,8-hexamethyl-5,6,7,8-tetrahydronaphthalen-2-yl)ethan-1-one
Details on test material:
Tonalid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
undiluted AHTN moistened with water
Duration of treatment / exposure:
4 hour(s)
Observation period:
168 hour(s)
Number of animals:
3
Details on study design:
A four hour semi-occlusive patch test conducted on four female New Zealand white albino rabbits. A 0.5 ml aliquot of undiluted test material was applied to a 2.5 cm square of surgical lint B.P. which was then placed on an area of clipped, intact dorsal skin. The lint patches were held in place by encircling the trunk of the animal with a length of "Elastoplast" elastic adhesive bandage 10 cm wide. After four hours, the adhesive tapes were removed and the treated sites were cleansed by gentle swabbing with cotton wool soaked in warm water. One hour after removal of the patches and excess test material, the treated sites were assessed for reactions. Similar examinations were made at 24, 48, 72 and 168 hours after patch removal. Irritation was assessed and allocated a numerical value based on the following criteria: Erythema and Eschar Formation: 0 = No erythema; 1 = Very slight erythema (barely perceptible); 2 = Well-defined erythema; 3 = Moderate to severe erythema; 4 = Severe erythema (beet redness) to slight eschar formation (injuries in depth); Oedema Formation: 0 = No oedema; 1 = Very slight oedema (barely perceptible); 2 = Slight oedema (edges of area well defined by definite raising); 3 = Moderate oedema (raised approximately 1mm); 4 = Severe oedema (raised more than 1mm and extending beyond area of exposure).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
All animals
Time point:
other: 1, 24, 48, 72, 168 hours post application
Score:
0
Max. score:
4
Remarks on result:
other: No erythema in any rabbit at any time point
Irritation parameter:
edema score
Basis:
mean
Remarks:
All animals
Time point:
other: 1, 24, 48, 72, 168 hours post application
Score:
0
Max. score:
4
Remarks on result:
other: No edema in any rabbit at any time point

Any other information on results incl. tables

No reaction to treatment was observed in any animal throughout the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information An averaged value of 2 either in erythema or oedema means that the substance is an irritant to skin. Criteria used for interpretation of results: EU
Conclusions:
Classification: not irritating
Executive summary:

3 New Zealand White female rabbits were dermally exposed to 0.5 g AHTN (Tonalid®; purity>98%; moistened with 0.5 ml water) under a 6.25 cm2 semi-occlusive patch for 4 hr on the dorsal skin (clipped free of fur). Four hours later, the treated skin was cleaned by gentle swabbing with cotton wool soaked in warm water. Skin observations were at 1, 24, 48, 72, and 168 hr after patch removal. Controls were not used. No erythema or oedema was seen in any rabbit at any time point.

Source: EU Risk Asssessment Report AHTN, Luxembourg, Office for Official Publications of the European Communities, ECB (May 2008)