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EC number: -
CAS number: -
A slight irritation was shown by the mice in the 100% dose group. It was
judged of no toxicological significance which had no effect on the
activity of the nodes.
An assessment of contact hypersensitivity to Alkylated Naphthalene was
made with the Mouse Local Lymph Node Assay. The study was carried out
based on the guidelines described in:
OECD, Section 4, Health Effects, No.429 (2010),
EC, No 440/2008; B42: "Skin Sensitization: Local Lymph Node Assay"
EPA, OPPTS 870.2600 (2003) “Skin Sensitization”.
Test substance concentrations selected for the main study were based
on the results of a pre-screen test.
In the main study, three experimental groups of five female CBA/J mice
were treated with test substance concentrations of 25, 50 or 100% w/w
on three consecutive days, by open application on the ears. Five
vehicle control animals were similarly treated, but with vehicle alone
(Methyl ethyl ketone).
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 and pooled for each animal. 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 (SI) was subsequently calculated for
The slight irritation of the ears as shown
by all animals treated at 100% was considered not to have a
toxicologically significant effect on the activity of the nodes.
The majority of auricular lymph nodes were considered normal in size,
except for the nodes of most animals treated at 50 and 100%.
No macroscopic abnormalities of the surrounding area were noted in any
of the animals.
Mean DPM/animal values for the experimental groups treated with test
substance concentrations 25, 50 and 100% were 215, 308 and 315 DPM
respectively. The mean DPM/animal value for the vehicle control group
was 236 DPM.
The SI values calculated for the substance concentrations 25, 50 and
100% were 0.9, 1.3 and 1.3 respectively.
Since there was no indication that the test
substance elicited an SI≥3
when tested up to 100%, Alkylated Napthalene was considered to be a
non skin sensitizer
The six-month reliability check with Alpha-hexylcinnamicaldehyde
indicates that the Local Lymph Node Assay as performed at WIL Research
Europe is an appropriate model for testing for contact
Based on these results, Alkylated Naphthalene would not be regarded as
a skin sensitizer according to the recommendations made in the test
guidelines. The test substance does not have to be classified and has
no obligatory labelling requirement for sensitization by skin contact
according to the Globally Harmonized System of Classification and
Labelling of Chemicals (GHS) of the United Nations (2011) and theRegulation
(EC) No 1272/2008 on classification, labelling and packaging of
substances and mixtures.
A GLP Mouse LLNA sensitisation study (OECD 429) was conducted with a
close structural analog of alkylnaphthalene. The results showed the
substance was not sensitising and does not require classification.
In addition, a sensitization study was obtained during the inquiry
process that showed that a substance with the same EC number as
Alkylnaphthalene was not sensitizing in an in vivo Buehler guinea pig
Based on recommendations of OECD guideline, the substance would not be
considered a skin sensitiser. The SI index was less than 2. Therefore,
no classification is required according to CLP (Regulation EC No
1272/2008) or DSD (Directive 67/548/EEC.
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