Tributyl-2-methoxypropylphosphonium salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol]

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:
Vehicle: dimethyl formamide

Species: Mouse, CBA strain, inbred, SPF-Quality.

Source: Charles River France, L'Arbresle Cedex, France.

Number of animals: 20 females (four groups of five females
each group). (nulliparous and non-pregnant).


In the main study, three groups of five experimental animals
were epidermally exposed to 10%, 25% or 50% concentrations
of test substance in vehicle on three consecutive days. Five
vehicle control animals were similarly treated, but with
vehicle alone (Dimethyl formamide).

Three days after the last exposure, all animals were
injected with 3H-methyl thymidine and after five hours the
draining (auricular) lymph nodes were excised.

After precipitating the DNA of the lymph node cells,
radioactivity measurements were performed. The activity was
expressed as the number of Disintegrations Per Minute (DPM)
and a stimulation index is calculated for each group.

Results and discussion

Details on results:

The irritation of the ears as shown by the animals, 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 the nodes of one animal treated at 50% test substance
concentration, which were increased in size.

No macroscopic abnormalities of the surrounding area were
noted.


Mean DPM/animal values for the experimental groups treated
with test substance concentrations 10, 25 and 50% were 267,
888 and 1175 respectively.

The mean DPM/animal value for the vehicle control group was
242.


The SI values calculated for the substance concentrations
10, 25 and 50% were 1.1, 3.7 and 4.9 respectively.


These results indicate that the test substance could elicit
an SI >= 3. The data showed a dose-response and an EC3 value
of 21% was calculated.


The six monthly reliability check with Hexylcinnamic
aldehyde indicates that the Local Lymph Node Assay as
performed at NOTOX is an appropriate model for testing for
contact hypersensitivity.


Based on these results:

- according to the recommendations made in the test
guidelines, MTDID 3285 would be regarded as skin sensitizer.

- according to the Globally Harmonized System of
Classification and Labeling of Chemicals (GHS) of the United
Nations (New York and Geneva, 2003), MTDID 3285 should be
classified as skin sensitizer (Category 1).

- according to the EC criteria for classification and
labeling requirements for dangerous substances and
preparations (Council Directive 67/548/EEC), MTDID 3285
should be labeled as: may cause sensitization by skin
contact (R 43).