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EC number: 237-487-6
CAS number: 13814-97-6
24 hours and 48 hours after challenge slight
erythema were observed at the side treated with the compound in the test
group. The control side of the test and control group (right flank) was
without any findings.
In the control group partly slight primary skin
reaction were observed 24 hours post administration at the test substance
side. After 48 hours post adminsitration the concerning animals of this group
were again without any findings.
Read-across concept (human
health) for tin bis(tetrafluoroborate):
Substance-specific toxicity data for
the substance tin bis(tetrafluoroborate) (water solubility >50 % w/w)
are not available.However, since upon dissolution in water, full
dissociation of the highly water-soluble tin bis(tetrafluoroborate) to
(i) Sn2+cations and (ii) tetrafluoroborate anions occurs,
read-across to (i) inorganic tin(II) substances and (ii) inorganic salts
of tetrafluoroboric acid is made, respectively.
This read-across is considered fully
justified in view of the comparable water solubilities of the similarly
soluble read-across substances, such as (i) tin(II)chloride, water
solubility 178 g/L at 20°C, and (ii) potassium tetrafluoroborate, water
solubility 5.4 g/L at 22°C.
Whereas it is noted that upon dilution
of aqueous solutions, “clouding” and precipitation of basic tin salts
occurs , which can be described by the following equation:
SnX2+ H2O <-->
"SnXOH"(s) + HX
behaviour is not considered to restrict the read-cross since oral
bioavailability of inorganic tin(II) substances is generally very low.
Potassium tetrafluoroborate is
currently not classified according to the criteria specified by
Directive 67/548/EEC and subsequent regulations, and is correspondingly
considered not to require classification according to the criteria set
forth by EC Regulation No. 1272/2008 and subsequent regulations, neither
for HH or ENV hazards.
Any toxicological or ecotoxicological
hazards (if any) are therefore assumed to be related to Sn2+only.
reliable test report according to OECD Guideline 406 (Skin
Sensitisation) with the read-across substance tin(II)
bis(methanesulfonate) is available. The test substance is
considered to be a skin sensitizer. 10/20 (50%) animals showed a
sensitisation properties of KBF4 were studied in a GLP-compliant OECD
Guideline 429 study with mice (TNO Triskelion BV, 2012). Three test
groups of 4 female mice each were treated with 10, 25 and 50% KBF4 by
means of open application of 25 μL to the dorsum of each ear for three
consecutive days. Three days after the last treatment, all animals
received an intravenous injection of 3H-thymidine. Five hours later, the
3H-thymidine incorporation in the draining auricular lymph nodes was
determined. The results were compared with those of a negative control
group which was treated with the vehicle (acetone/olive oil, 4:1 v/v).
Group mean 3H-thymidine incorporations of 1356, 1346 and 1235 DPM were
found in the auricular lymph nodes of animals treated with respectively
10%, 25% and 50% KBF4 formulations. The group mean value in the vehicle
control animals was 919 DPM. The calculated stimulation indices (SI),
representative of the change in 3H-thymidine incorporation in KBF4
treated animals compared to controls, were 1.47, 1.46 and 1.34 for the
tested doses of 10%, 25% and 50% KBF4, respectively. Since the SI was <
3, the limiting value required for classification as a skin sensitiser,
in response to all concentrations of KBF4 tested and no dose response
relationship was apparent it was concluded that KBF4 did not have a skin
sensitising potential when applied up to concentrations of 50%.
The read-across test substance tin(II)
bis(methanesulfonate) is considered to be a skin sensitizer.
10/20 (50%) animals showed a positive response. According to the
EC-Commission directive 67/548/EEC and its subsequent amendments, the
test substance is a skin sensitizer. According to the EC-Regulation
1272/2008 and subsequent regulations, the test item is classified in
Based on the assumption that the
sensitisation effect originates from Sn2 + and taking into
account the proposed read-across approach, the test item tin
bis(tetrafluoroborate) has to be classified as a skin sensitiser.
According to the EC-Commission directive
67/548/EEC and its subsequent amendments, the test substance is a skin
sensitizer. According to the EC-Regulation 1272/2008 and subsequent
regulations, the test item is classified in Category 1.
on the findings in the skin sensitisation study, the substance does not
need to be classified according to Directive 67/548/EEC and according to
the EU Classification, Labelling and Packaging of Substances and
Mixtures (CLP) Regulation (EC) No. 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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