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EC number: 947-115-0
CAS number: -
Skin sensitisation: SI value < 1 for all
tested concentrations (BASF SE, 2016)
In this study the test item Disodium
(sulphonatothio)acetate; dried was assessed for its skin sensitising
potential using the Local Lymph Node Assay (LLNA) in mice (BASF SE,
58V0318/14X507, 2016). Test item solutions at different concentrations
were prepared in the vehicle ethanol/water (3+7, v/v).
The local lymph node assay is recommended by
international test guidelines (e.g., OECD) as an animal test for
predicting skin sensitisation in humans and provides a rational basis
for risk assessment. The basic principle underlying the LLNA is that
sensitisers induce a primary proliferation of lymphocytes in the lymph
node draining the application site. The ratio of proliferation in test
item treated groups compared to that in vehicle controls is termed the
Stimulation Index (S.I.). Radioactive labeling is used to measure cell
For this purpose a local lymph node assay
was performed using test item concentrations of 5, 10, and 25% (w/w).
The highest concentration tested was the highest concentration that
could be technically achieved whilst avoiding systemic toxicity and
excessive local skin irritation (as determined by a pre-experiment).
The animals showed neither signs of systemic
toxicity nor local skin irritation during the course of the study and no
cases of mortality were observed. A statistically significant or
biologically relevant increase in ear weights was not observed in any
treated group in comparison to the vehicle control group. Furthermore,
for BALB/c mice, a cut-off value of 1.1 for the ear weight index was
reported for a positive response regarding ear skin irritation. None of
the indices determined for the test item treated groups reached or
exceeded this threshold.
A test item is regarded as a sensitiser in
the LLNA if exposure to one or more test item concentration results in a
3-fold or greater increase in incorporation of 3HTdR compared with
concurrent controls, as indicated by the Stimulation Index (S.I.). The
estimated test item concentration required to produce a S.I. of 3 is
referred to as the EC3 value.
In this study Stimulation Indices (S.I.) of
0.90, 0.95, and 1.68 were determined with the test item at
concentrations of 5, 10, and 25% (w/w) in ethanol/water (3+7, v/v),
respectively. Thus, a clear dose response was observed.
A statistically significant and biologically
relevant increase in DPM value and also in lymph node weight and -cell
count was not observed in any dose group in comparison to the vehicle
control group. Furthermore, the cut-off value of 1.55 for a positive
response regarding the lymph node cell count index reported for BALB/c
mice was not reached or exceeded in any dose group.
The test item Disodium
(sulphonatothio)acetate; dried was thus not a skin sensitiser under the
test conditions of this study.
The available experimental test data are
reliable and suitable for classification purposes under Regulation
1272/2008. As a result the substance does not need to be classified and
labelled as skin sensitising under Regulation (EC) No 1272/2008, as
amended for the tenth time in Regulation (EU) No 2017/776. Further, no
skin irritating properties were observed.
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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