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EC number: 947-528-6
CAS number: -
one Guideline study on skin corrosion in vitro testing available. The
results indicate no effects on the RHE test system at all. This
information is concluded to be sufficient for the endpoint skin
irritation in vitro testing as well.
one Guideline study on eye irritation available
One valid experiment was performed.
Two tissues of the human skin model EpiDermTM were treated with the test
Bis(neodecanoyloxy)dioctylstannane for 3 minutes and 1 hour,
respectively. The test item
was applied to each tissue and spread to match the tissue size.
Demineralised water was used as negative control, 8 M KOH was used as
After treatment, the respective substance was rinsed from the tissues.
Then, cell viability of
the tissues was evaluated by addition of MTT, which can be reduced to a
Formazan production was evaluated by measuring the optical density (OD)
at 570 nm of the
After treatment with the negative control, the absorbance values were
within the required
acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for both treatment
intervals thus showing
the quality of the tissues. The OD was 1.8 (3 minutes experiment) and
1.6 (1 hour experiment).
The positive control showed clear corrosive effects for both treatment
mean relative tissue viability value was reduced to 7.8 % after the 1
hour treatment (and
reduced to 19.5 % after the 3 min treatment).
After 3 minutes treatment with the test item, the mean value of relative
tissue viability was
reduced to 95.5 %. This value is above the threshold for corrosion
potential (50%). After 1
hour treatment, the mean value of relative tissue viability was
increased to 102.5 %. This
value, too, is above the threshold for corrosion potential (15%).
Therefore, Bis(neodecanoyloxy)dioctylstannane is considered
non-corrosive to skin in the Reconstructed Human Epidermis (RHE) Test
Bovine corneas were used. They were collected from slaughtered cattle
which were between
12 and 60 months old.
The test item Bis(neodecanoyloxy)dioctylstannane was brought onto the
cornea of a bovine
eye which had been incubated with cMEM without phenol red at 32 ± 1 °C
for 1 hour
and whose opacity had been measured.
The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C.
After removal of
the test item and 2 hours post-incubation, opacity and permeability
values were measured.
HBSS-solution was used as negative control. The negative control showed
effect on the cornea and the calculated IVIS (in vitro irritancy score)
Dimethylformamide (DMF) undiluted was used as positive control. The
positive control induced
serious eye damage on the cornea and falls within two standard
deviations of the
current historical mean. The calculated IVIS (in vitro irritancy score)
Under the conditions of this study, the test item
showed no effects on the cornea of the bovine eye. The calculated IVIS
(in vitro irritancy
score) is 2.13.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an
IVIS ≤ 3 requires
no classification for eye irritation or serious eye damage.
The available information is conclusive but not sufficient for
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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