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EC number: 204-649-2
CAS number: 123-76-2
The skin sensitisation potential of the
substance was evaluated considering data from an in-vivo study as well
data obtained from an in-vitro study on Similar Substance 01.
Justification for Read Across is given in Section 13 of IUCLID.
The ability of the substance to induce
skin sensitisation in the CBA/JN mouse, was evaluated using the Local
Lymph Node Assay (LLNA: BrdU-ELISA method) according to the OECD
Guideline 442b. In the main assay, the test item was topically
administered at the concentrations of 25, 10 and 5 % (w/w), in
acetone:olive oil 4:1 (v/v) for three consecutive days. After one day of
no treatment, BrdU solution was injected inter-peritoneally. Twenty four
hours after BrdU injection, the animals were killed and the auricular
lymph nodes were rapidly excised, pooled on individual basis and
individually collected. Cell suspensions were prepared for the
evaluation of proliferation at lymph node. An increase in cell
proliferation of draining lymph nodes was observed in the high, medium
and low dose groups with SI of 2.05, 1.88 and 1.31 respectively,
indicating that the test item may elicit a sensitisation response.
Dunnett’s test showed a statistically significant difference between
mid- and high dose groups, when compared to the negative control group.
The substance is considered to be a skin sensitiser.
The in vitro intrinsic sensitizing
potential of the similar substance was evaluated according to the human
cell line activation test (h-CLAT) following the OECD Guideline 442E.
THP-1 cell cultures were exposed to eight concentrations of the test
item, ranging from 39.1 to 5000 μg/ml, for 24 hours. After exposure, the
expression of two cell surface antigens, CD86 and CD54, was measured by
flow cytometry method. Vehicle control (RPMI), negative control (LA) and
positive controls (DNCB and NiSO4) run in parallel. The chemicals were
tested in two independents experiments. RFI of CD54 was higher than 200
in two experiments at 5000 μg/ml concentration. Since the RFI of CD54
exceeded 200 % in two experiments the substance should be identified as
a skin sensitizer.
According to the CLP Regulation (EC) No.
Annex I: 220.127.116.11. Skin Sensitisers Annex
I: 18.104.22.168.1. Hazard categories
Annex I: 22.214.171.124.1.1. Skin sensitisers
shall be classified in Category 1 where data are not sufficient for
Annex I: 126.96.36.199.1.2. Where data are
sufficient a refined evaluation according to section 188.8.131.52.1.3 allows
the allocation of skin sensitisers into sub-category 1A, strong
sensitisers, or sub-category 1B for other skin sensitisers.
Annex I: 184.108.40.206.1.3. Effects seen in
either humans or animals will normally justify classification in a
weight of evidence approach for skin sensitisers as described in section
220.127.116.11.2. Substances may be allocated to one of the two sub-categories
1A or 1B using a weight of evidence approach in accordance with the
criteria given in Table 3.4.2 and on the basis of reliable and good
quality evidence from human cases or epidemiological studies and/or
observations from appropriate studies in experimental animals according
to the guidance values provided in sections 18.104.22.168.2.1 and 22.214.171.124.3.2
for sub-category 1A and in sections 126.96.36.199.2.2 and 188.8.131.52.3.3 for
Data from the in-vitro OECD442E do not
permit any subclassification. The results obtained in this study suggest
that the substance is a skin sensitiser. Data from the in-vivo OECD 442E
also do not permit any subclassification. The SI index obtained in all
the three concentrations tested was above 1.6 and there was
statistically significant difference between mid- and high dose groups,
when compared to the negative control group. Considering data obtained
from both studies, the substance is classified in Category 1 (H317)
for skin sensitisation according to the CLP Regulation (EC) No.1272/2008.
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