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EC number: 205-232-8
CAS number: 136-23-2
Available GLP-compliant skin irritation study and three independent eye irritation studies with rabbits suggest that zinc bis(dibutyldithiocarbamate) (ZDBC) is not irritating to skin and eyes. However, as the substance is already classified on Annex I of EU Directive 67/548/EEC as skin and eye irritant, this shall be taken into account by performing the risk assessment.
One GLP-compliant study on skin irritation
with zinc bis(dibutyldithiocarbamate) (ZDBC), performed in accordance
with Draize method, was available for assessment (Monsanto Company,
1982c). A mass of ca. 0.5 g of the test material, moistened with
physiological saline, was applied to each of two preliminary shaved
intact and two abraded sites of 3 male and 3 female New Zealand White
rabbits for 24 hours under occlusive dressing. The initial observation
for skin irritation was made approximately one hour after the removal of
the wrappings. Dermal irritation was scored by the method of Draize
(1944), and results were recorded on the first and third days after
topical application. The Primary Irritation Index was calculated by
averaging the mean scores at 24 and 72 hours.
Only one out of six animals had a slight
erythema (score 1) at the intact test site 24 hr post-application, which
resolved at 72 hours examination. The overall PII for both intact and
abraded skin sites was 0.1 on the scale from 0.0 to 8.0. Based on the
results of the test, zinc bis(dibutyldithiocarbamate) was concluded to
be not irritating to rabbit skin.
Three independent eye irritation studies
with zinc bis(dibutyldithiocarbamate) were available for assessment. Out
of these studies, the most recent one, performed under GLP and in
accordance with the method of Draize, was chosen as a key study
(Monsanto Company, 1982d). A volume of 0.1 ml of test material was
instilled into the conjunctival sac of the right eye of each out of 3
male and 3 female New Zealand White rabbits. Observations for signs of
irritation were conducted on the first, second, and third days after
dosing. The untreated eye of each animal served as a negative control.
The cornea and iris score were 0 at all time points in all animals. One
rabbit had a conjunctivae score 4 and another a conjunctivae score 2 at
24 hr examination. In both cases irritation was resolved at 48 hr
examination. Also only minor signs of irritation, resolved within 72
hours, were observed in other two studies. Based on these results, zinc
bis(dibutyldithiocarbamate) is concluded to be not irritating to rabbit
However, although the results of the
available studies suggest that zinc bis(dibutyldithiocarbamate) does not
possess skin and eye irritating properties, the substance is already
included in Annex I of EU Directive 67/548/EEC as irritating to skin,
eyes and respiratory tract (Xi, R36/37/38). Therefore, using a
precautionary principle, this classification shall be taken into account
at the performance of risk assessment.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Effects on respiratory irritation: irritating
Zinc bis(dibutyldithiocarbamate) (ZDBC) is
included in Annex I of EU Directive 67/548/EEC as skin, eye and
respiratory tract irritant (Xi, R36/37/38). In accordance with EU
Classification, Labelling and Packaging of Substances and Mixtures (CLP)
Regulation (EC) No. 1272/2008, it should be classified as Category 2,
H315 (causes skin irritation), H319 (causes serious eye irritation) and
STOT - single exposure, Category 3, H335 (may cause respiratory
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