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Specific investigations: other studies

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specific investigations: other studies
Adequacy of study:
other information

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Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Principles of method if other than guideline:
Test procedure:
- Organisation for Economic Co-operation and Development
(OECD), OECD Guidelines for Testing of Chemicals, Section 4,
Health Effects, No.429, "Skin Sensitisation: Local Lymph
Node Assay", Paris Cedex, April 2002.


- European Community (EC), Council Directive 67/548/EEC,
Annex V, Part B, Methods for the Determination of Toxicity,
as last amended by Commission Directive 2004/73/EC, B.42:
"Skin sensitisation: Local Lymph Node Assay", April 2004.


- Environmental Protection Agency (EPA): Health Effects Test
Guidelines OPPTS 870.2600. (Skin Sensitisationö, March 2003
.

Results and discussion

Details on results:
Slight erythema of one ear was noted in one animal at 50%.
White staining of the ears by the test substance was noted
in the animals at 50%, but did not hamper scoring for
erythema. No oedema was observed in any of the animals
examined. The irritation of the ears as shown by the animal
was considered not to have a toxicologically significant
effect on the activity of the nodes.


The majority of nodes were considered normal in size, except
for one or both nodes of 3 animals at 50%.

No macroscopic abnormalities of the surrounding area were
noted.


Body weights and body weight gain of experimental animals
remained in the same range as controls over the study
period.


Mean DPM/animal values for the experimental groups treated
with test substance concentrations 10, 25 and 50% were 203,
173 and 910 respectively.

The mean DPM/animal value for the vehicle control group was
153.


No mortality occurred and no symptoms of systemic toxicity
were observed in the animals of the main study.


The SI values calculated for the substance concentrations
10, 25 and 50% were 1.3, 1.1 and 5.9 respectively.


These results indicate that the test substance could elicit
an SI >= 3. The test substance should be regarded as a skin
sensitiser. An EC50 of 35% was calculated.

Applicant's summary and conclusion