[No public or meaningful name is available]

Specific investigations: other studies

Administrative data

Endpoint:

specific investigations: other studies

Adequacy of study:

other information

Data source

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 Sensitisation", March 2003
.

Results and discussion

Details on results:

The dpm value for control animal 4 was disregarded since it
fell outside the historical range for the controls. The mean
dpm/animal value for the controls was calculated from the
measurements derived from the remaining four animals.


Slight erythema was noted on the ears of one animal at a 25%
test substance concentration and most animals at a 50% test
substance concentration. The irritation of the ears was
considered not to have a toxicologically significant effect
on the activity of the nodes. No skin irritation was
observed at a 10% test substance concentration, and no
oedema was observed in any of the animals examined.


The majority of nodes were considered normal in size, except
for the right node of one control animal. 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. The slight body weight loss, noted in some animals,
was considered not toxicologically significant.


Mean DPM/animal values for the experimental groups treated
with test substance concentrations 10, 25 and 50% were 365,
438 and 709 respectively. The mean DPM/animal value for the
vehicle control group was 327.


The SI values calculated for the substance concentrations
10, 25 and 50% were 1.1, 1.3 and 2.2 respectively. Since
there was no indication that the test substance could elicit
an SI >= 3 when tested up to 50%, it was established that
the EC3 value (if any) exceeds 50%. The test substance would
not be regarded as a skin sensitiser.