Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 211-334-3
CAS number: 638-38-0
a dermal sensitization study similar to OECD 429 (murine local lymph
node assay) with manganese chloride (25, 10, 5 % (w/v)) and lead acetate
(10, 5, 2.5 % (w/v)) in petrolatum resp. DMSO, 7-12 week old CBA/Ca mice
(4 animals / dose group) were tested using the ³H-thymidine
incorporation method. The test substance was applied on three
consecutive days on the dorsum of each ear, local lymph nodes were
isolated on the fifth day, 5 h after ³H-thymidin was injected in the
tail vein, and beta-scintillation was measured. No clinical signs and
mortality was recorded. The stimulation index (SI) was determined to be
0.6 – 1.1 for both substances, so manganese (II) acetate is not a dermal
sensitizer. This study is considered to be reliable and to fulfill the
requirements for a study similar to OECD 429.
Both studies performed on manganese
chloride (Ikarashi 1992) and manganese chloride and lead acetate
(Basketter 1999)are performed similar to EU method B.42 resp. OECD
guideline 429 with only minor deviations. The studies’ performances are
well-documented and meet the guideline requirements for a murine local
lymph node assay and general scientific principles. So the results can
considered to be reliable and useful for the assessment of the
sensitizing potential of Manganese (II) acetate. MnCl2 serves a
read-across substance for Mn(acO)2, and taking into account the results
from MnCl2 and lead acetate, manganese (II) acetate as a whole can be
assessed by regarding both the cation Mn2+ and the anion CH3COO-. In
both studies, the stimulation index SI was mostly below 1, only once
1.1, at all tested substances and concentrations. Therefore, all tested
substances and concentration can considered to be not sensitizing to the
skin, and neither is Manganese (II) acetate.
Hence, it can be concluded that the
provided data is sufficient for classification as "not sensitizing"
according to regulation 1272/2008/EC and directive 67/548/EEC and
further testing would not reveal any other contradicting data, so it can
According to regulation 1272/2008/EC, a
substance must be classified as skin sensitizer Category 1 if the
following criteria are met:
(i) if there is evidence in humans that the
substance can lead to sensitisation by skin contact in a substantial
number of persons, or
(ii) if there are positive results from an
appropriate animal test.
According to directive 67/548/EEC, a
substance may cause sensitisation by skin contact
if practical experience shows the
substance or preparation to be capable of inducing a sensitisation by
skin contact in a substantial number of persons, or
where there are positive results from an
appropriate animal test.
So far, human data is not available for manganese
(II) acetate, but both animal studies gave clear evidence that manganese
(II) acetate is not a skin sensitizer. Consequently, it does not need to
be classified, neither according 1272/2008/EC nor directive 67/548/EEC.
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again