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EC number: 291-639-6
CAS number: 90432-09-0
The following data were obtained for
Similar Substance 01. It is expected that the Target Substance will
present similar skin sensatisation potential. Justification for the use
of a Read Across approach is provided in Section 13 of IUCLID.
The potential of Similar Substance
01 to cause skin sensitisation reactions following topical application
to the skin of CBA/JN mice, was assessed using the LLNA:BrdU-ELISA
method, according to the OECD Guideline for testing of chemicals No.
442b (2010). Five concentrations [25 (maximum feasible concentration),
10, 5, 2.5 and 1 % w/w in acetone: olive oil 4:1 (v/v)] were tested in
the preliminary phase, in order to identify a non toxic and minimally
irritant concentration and avoid false positive results. Based on the
results observed, in the main assay, Similar Substance 01 was topically
administered at the concentrations of 25, 10 and 5 % (w/w), in acetone:
olive oil 4:1 (v/v).
No mortality nor clinical signs were
recorded in any animal. Changes in bodyweight observed during the study
were within the expected range for this strain and age of animals. A
slight increase in cell proliferation of draining lymph nodes was
observed in the low dose group, with a Stimulation Index of 1.98. The
other calculated indices (SI) were 0.95 and 1.28 respectively, in medium
and high dose groups. No correlation with the doses nor statistical
significance was observed. These results indicate that Similar Substance
01 may elicit a sensitisation response. However, due to the presence of
an outlier in the low dose group, the absence of dose-response
relationship and statistical significance, the observed reaction is not
sufficient to indicate classification.
Similar Substance 02 also tested negative
to skin sensitisation potential in the in vivo LLNA assay,
according to the EU Method B.42 (2012). In an experimental study on
Similar Substance 03, it also tested negative to skin sensitising
potential in a different skin sensitisation test, the in vivo
Guinea Pig Maximisation Test (GPMT), according to the OECD Guideline 406
(1981) and the EU Method B.6 (1984), whereby 20 Guinea Pigs were
administered Similar Substance 03 intradermally and were subsequently
challenged topically alongside both negative and positive controls; no
animals demonstrated sensitisation after 24 or 48 hours. The
presence of consistently negative skin irritation experimental studies
across the board supports the use of the read-across approach for
estimating the skin sensitising potential of the Target Substance.
the CLP Regulation (EC 1272/2008) a skin sensitizer is defined as “a
substance that will lead to an allergic response following skin
contact”. A substance classified as skin sensitiser (Category 1) may be
allocated to one of the two sub-categories 1A or 1B in accordance with
the criteria given in Annex I, Part 3, Table 3.4.2.
case of animal tests, for the reduced LLNA:BrdU-ELISA
(OECD TG 442B) the
criteria for determining the positive response is different from that of
the traditional LLNA (OECD TG 429). Full details are given in the
corresponding OECD Test Guidelines. There is no guidance for
to the OECD 442B (2010): the decision process regards a result as
positive when SI ≥ 1.6. However, the strength of the dose-response
relationship, the statistical significance and the consistency of the
solvent/vehicle and PC responses may also be used when determining
whether a borderline result (i.e. SI value between 1.6 and 1.9) is
declared positive. For a borderline positive response between a SI of
1.6 and 1.9, users may want to consider additional information such as
dose-response relationship, evidence of systemic toxicity or excessive
irritation, and where appropriate, statistical significance together
with SI values to confirm that such results are positives. Consideration
should also be given to various properties of the test substance,
including whether it has a structural relationship to known skin
sensitizers, whether it causes excessive skin irritation in the mouse,
and the nature of the dose-response observed. These and other
considerations are discussed in detail elsewhere.
on the results of skin sensitisation of the LLNA: BrdU-ELISA performed
on the test substance, there is no dose-response relationship and no
statistical significance. Moreover, the SI values obtained in the medium
and high dose groups are < 1.6; the only higher SI value obtained in the
low dose group is due to an outlier. Considering the aforementioned, no
classification for skin sensitization is warranted under the CLP
Regulation (EC 1272/2008).
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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