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EC number: 238-778-0
CAS number: 14726-36-4
No data on
acute toxicity of zinc bis(dibenzyldithiocarbamate) (ZBEC) were
available for assessment. However, based on the data from the structural
analogue zinc bis(dibutyldithiocarbamate) (ZDBC), the acute toxicity of
zinc bis(dibenzyldithiocarbamate) via oral and dermal routes of exposure
is considered to be low, with LD50 > 2000 mg/kg bw/day. No data on
inhalation route of exposure are available; however, the performance of
a study is not warranted in accordance with Column 2 of REACH Annex X,
as the data on two other routes of exposure are available.
No data on acute toxicity of zinc
bis(dibenzyldithiocarbamate) (ZBEC) were available for the assessment. However,
Article 13 of the REACH legislation states that, in case no appropriate
animal studies are available for assessment, information should be
generated whenever possible by means other than vertebrate animal tests,
i.e. applying alternative methods such as in vitro tests, QSARs,
grouping and read-across.
Several acute oral toxicity studies with a
structural analogue zinc bis(dibutyldithiocarbamate) (ZDBC) were
available for assessment, all reporting LD50 values well above 2000
mg/kg bw. Out of these studies, the most recent one (Monsanto Company,
1982), performed under GLP, was chosen as a key study. Five
Sprague-Dawley rats of each sex were administered a single oral dose of
5000 mg/kg bw of the test substance as a 434 mg/ml suspension in corn
oil. No mortalities occurred and no abnormal findings were noted at
necropsy. Diarrhea occurred in three males and five female rats on the
day of dosing, but this effect was probably induced by the corn oil used
as the dosing vehicle.
Two acute dermal toxicity studies with
rabbits using the same test substance were available for assessment, one
with very limited reporting. Respectively, the other one, more recent
GLP-compliant study (Monsanto, 1982) was chosen as a key study. The test
material moistured with physiological saline was administered to abraded
skin of a dorsal surface of five New Zealand White rabbits of each sex
in the amount of 2000 mg/kg bw under occlusive conditions. After 24
hours the patch was removed, the excessive test material wiped off, and
the animals were observed for 14 days and necropsied afterwards. There
were no mortalities. Erytherna was observed in the exposed area of three
male animals and one female rabbit on the first day after exposure. No
other clinical abnormalities were noted. At necropsy, pale renal
coloration was observed in one male animal, but this was not considered
to be related to exposure to the test material. No abnormalities were
observed in the remaining nine rabbits.
Overall, based on the data from the
structural analogue zinc bis(dibutyldithiocarbamate) (ZDBC), acute
toxicity of zinc bis(dibenzyldithiocarbamate) (ZBEC) is considered to be
low as well, with LD50 values for dermal and oral toxicity in rats above
the cut-off limit of 2000 mg/kg bw. No data on inhalatory route of
exposure were available for assessment. However, the performance of the
study is not warranted in accordance with Column 2 of REACH Annex VIII,
as data on acute toxicity by other two routes of exposure are available.
Based on the data from the structural
analogue zinc bis(dibutyldithiocarbamate) (ZDBC), for which LD50 values
in rats of > 5000 mg/kg bw and > 2000 mg/kg bw were reported for acute
oral and acute dermal toxicity, respectively, classification of zinc
bis(dibenzyldithiocarbamate) (ZBEC) for acute toxicity is not warranted
in accordance with Directive 67/548/EEC and 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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