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EC number: 268-500-3
CAS number: 68109-88-6
Table 2: Disintegrations per Minute, Disintegrations per Minute/Node
and Stimulation Index
Concentration (% w/w) in vehicle
stimulation index #
dpm = Disintegrations per minute
* Disintegrations per minute/node obtained by dividing the
disintegrations per minute value by 8 (total number of lymph nodes)
# Stimulation index of 3.0 or greater indicates a positive result
na = not applicable
The skin sensitisation potential of the test material was determined in
accordance with the standardised guidelines OECD 429 and EU Method B.42
using the mouse Local Lymph Node Assay. The test material was applied as
a 5 %, 10 % or 25 % w/w preparation in propylene glycol. The positive
control was shown to have the capacity to cause skin sensitisation
confirming the validity of the protocol used for this study. The isotope
concentration induced by the test material was less than three-fold at
all test concentrations and therefore the test material is considered to
be unlikely to be a skin sensitiser.
Skin sensitisation was addressed using a read-across approach. The test
material DOTO (di-n-octyltin oxide) is in the same category of
substances as the registered substance and as such it is considered
acceptable to use a read-across approach to address this endpoint.
A GLP study conducted to standardised guidelines OECD 429 and EU Method
B.42, using the mouse Local Lymph Node Assay, was designated the key
study for this endpoint. The test material was applied as a 5 %, 10 % or
25 % w/w preparation in propylene glycol. The positive control was shown
to have the capacity to cause skin sensitisation confirming the validity
of the protocol used for this study. The isotope concentration induced
by the test material was less than three-fold at all test concentrations
and therefore the test material is considered to be unlikely to be a
As the study was performed on a read-across substance, the study was
assigned a reliability score of 2 (reliable with acceptable
restrictions) in accordance with the criteria for assessing data quality
as outlined in Klimisch (1997) and considered suitable for assessment as
an accurate reflection of the test material.
The available data are considered to be complete and the conclusion, not
sensitising, was taken forward for risk assessment.
In accordance with the Regulation (EC) No. 1272/2008 and Directive
67/548/EEC, based on the results of the presented Local Lymph Node
Assay, in which no sensitising potential was demonstrated, the substance
does not require classification as a skin sensitiser.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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