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EC number: 269-950-3
CAS number: 68391-42-4
Not skin sensitising.
no data on target substance was available, skin sensitising potential
was assessed using a read across approach. Similar Substance 01 was used
as read across substance and further details were reported in section
Available data on Similar Substance 01 was
used in a weight of evidence approach.
Similar Substance 01 was tested according
to OECD guideline 429 (local lymph node assay). Male mice were exposed
to test substance at concentrations of 0, 3, 10 and 30 % in acetone.
Negative and positive controls were valid. The isotope (3H-methyl
thymidine) incorporation in lymph nodes was increased by less than a
threefold at all concentrations of test substance. Therefore, test
substance was considered to be not sensitising to mouse skin.
In addition, a study on Similar Substance
01 was available in literature. Modified protocols of the Local Lymph
Node Assay i.e. sensitisation and sensitisation-challenge protocols were
applied. Female NMRI mice were exposed to test substance at
concentrations of 10 and 30 % in DMSO, using DMSO alone as negative
control. In the sensitisation protocol, 25 µl of test substance solution
were applied for 3 consecutive days. 48 h after the last exposure, mice
were euthanised, ear thickness was measured, draining auricular lymph
nodes were excised and weighed, and cell suspensions were prepared to
count the number of cells.
In the sensitisation-challenge protocol,
50 µl test solution were applied once daily on days 1 - 3; mice remained
untreated on days 4 - 14 and were then challenged with 25 µl of test
solution on days 15 - 17. 48 h after the last exposure, mice were
euthanised, ear thickness was measured, draining auricular lymph nodes
were excised and weighed, and cell suspensions were prepared to count
the number of cells.
Lymphocyte subpopulations (T-cells and
B-cells, CD69 and 1A epitopes) were also analysed by flow cytometry.
Compared to controls, test substance did not induce any changes
regarding lymph node weight and cellularity, ear thickness, or
In both protocols, test substance was
considered not sensitizing to mouse skin.
A study on Similar Substance 01 according
to OECD guideline 406 was conducted on female guinea-pigs.
A pre-test was run to identify a maximally
tolerated concentration suitable for the induction phase of the main
study and a suitable non-irritant concentration, by topical route of
administration, for the challenge phase.
In the main study, intradermal induction
was carried out with a 5 % dilution of test substance in bi-distilled
water and in an emulsion with Freund's Complete Adjuvant (FCA) /
physiological saline; epidermal induction was conducted under occlusion
(clipped, shaved skin) with test substance at 50 % in bi-distilled
water. Approximately 22 h prior to the epidermal induction, test sites
were pretreated with a 10 % SLS solution in paraffinum perliquidum. Two
weeks after the epidermal induction application, challenge was completed
by epidermal application of test substance at 50 % in bi-distilled water
under occlusive dressing (clipped, shaved skin). Animals of control
group were induced with bi-distilled water and FCA/physiological saline,
pretreated with 10 % SLS and challenged similarly to those of test
group. Cutaneous reactions, i.e. erythema, eschar and oedema formation
were evaluated at 24 and 48 h after removal of the dressing. Mortality,
symptoms of systemic toxicity, and body weights were also investigated.
A normal development of the expected local
symptoms was observed in the animals of the control and test group
during the intradermal induction phase. After challenge, no reactions
were seen in control groups. Positive reactions were seen in all animals
at the 24 and 48 h readings when treated with test substance at 50 % in
Due to conflicting evidences with
different test types and samples, the following issues were taken into
account in drawing a conclusion on the skin sensitising potential:
- in LLNAs, either a test sample with high
purity (92 %) or a commercial sample with low purity (30 -35 %) gave no
- test sample used for in GPMT has a
purity of 42.3 % only with unknown composition
- the use of SLS causes often false
positive results in the GPMT
- in GPMT, treated areas were depilated
with Veet Cream to remove the red staining of test substance which
prevented erythema evaluation, but such cream may cause sensitising
On these bases, the GPMT result was
considered as not representative of a toxic potential of the substance
and it was excluded from the assessment.
Accordingly, the substance was taken as
not skin sensitising.
shall be classified as skin sensitizers in category 1 where data are not
sufficient for sub-categorisation in accordance with the following
if there is evidence in humans that the substance can lead to
sensitisation by skin contact in a substantial number of persons; or
if there are positive results from an appropriate animal test.
for LLNA, a stimulation index ≥
is considered as a positive response.
Subcategorisation is done as follows:
showing a high frequency of occurrence in humans and/or a high potency
in animals can be presumed to have the potential to produce significant
sensitisation in humans. Severity of reaction may also be considered.
Specific criteria: EC3 value ≤ 2 %
showing a low to moderate frequency of occurrence in humans and/or a low
to moderate potency in animals can be presumed to have the potential to
produce sensitisation in humans. Severity of reaction may also be
criteria: EC3 value > 2 %
on data derived from LLNAs, none concentration produced a stimulation
index of 3, thus no EC3 value could be derived and no classification
applied according to 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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