Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Specific investigations: other studies

Currently viewing:

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Principles of method if other than guideline:
Test procedure:
Species: Mouse, CBA strain, inbred, SPF-Quality.

Recognized by the international guidelines as the
recommended test system (e.g. OECD, EC, EPA).

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

Number of animals: 20 females (nulliparous and non-
pregnant), five females per group.



In the main study, three groups of five experimental animals
were treated with test substance concentrations of 5%, 25%
or 50% on three consecutive days, by open application on the
ears. Five vehicle control animals were similarly treated,
but with vehicle alone (Dimethyl sulphoxide).

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 was subsequently calculated for each
group.

Test material

Results and discussion

Details on results:
The SI values calculated for the substance concentrations 5,
25 and 50% were 9.4, 8.9 and 12.9 respectively.


These results show that the test substance elicits an SI >=
3. The EC3 value was established to be between 0 and 5%.

Applicant's summary and conclusion