Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
other: Unpublished RIFM report
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V of EEC Directive 79/831
Principles of method if other than guideline:
A 4 hour, semi-occlusive patch test was conducted on three New Zealand white albino rabbits using a 0.5 ml or 0.5 g aliquot of undiluted test material which was placed evenly over a 2.5 cm square of surgical lint B.P. The lint square was then placed onto a 6 cm square area of clipped, intact dorsal skin. The lint patches were held in place by encircling the trunk of the animals with a length of 'Elastoplast' elastic adhesive bandage 10 cm wide. After a period of 4 hours the adhesive tapes were removed and the treated sites cleansed by gentle swabbing with cotton wool soaked in warm water. Reactions were assessed at 1, 24, 48, 72 and 168 hours after patch removal. Irritation was assessed and allocated a numerical value based on the following: 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) to slight eschar formation (injuries in depth) = 4. 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 mm) = 3; Severe oedema (raised more than 1 mm and extending beyond area of exposure) = 4.


Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: average erythema score
Value:
ca. 1
Irritation / corrosion parameter:
other: average edema score
Value:
ca. 0.2

Applicant's summary and conclusion