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EC number: 700-071-4
CAS number: 932742-30-8
SIKA Hardener LI was assessed in a short-term toxicity to fish study, according to EU method C.1 and OECD guideline 203. Young Rainbow trout (Oncorhynchus mykiss) were exposed in a semi-static test to the test item for 96 hours to water accomodated fractions (WAF) with nominal concentrations of 6.25; 12.5; 25.0; 50.0 and 100.0 mg/L. The 96 h LC50 was determined to be 87.2 mg/L and the 96 h NOEC was determined to be 25.0 mg/L.
Due to the high reactivity of the substance
in water, a weight of evidence approach using data form the parent
molecule and its two primary hydrolysis products were assessed:
In the study with the parent compound SIKA
Hardener LI, young fish were exposed in a semi-static test to the test
item for 96 hours, added to test water at a range of concentrations. A
supersaturated test item solution (Stock solution = S.S.) was prepared
by dispersing the low water soluble test item amount (nominal load of
100 mg/L) into the Test Medium two days before the start of the renewal
periods. This solution was shaken for 24 hours at app. 30 ºC, then was
left settling for 24 hours at app. 20 ºC and thereafter filtrated
through a 0.45 μm filter. The following nominal concentrations were used
in the main study: 6.25; 12.5; 25.0; 50.0 and 100.0 mg/L. In this
96-hour semi-static acute toxicity test with Rainbow trout (Oncorhynchus
mykiss) the 96 h LC50 value was 87.2 mg/L, and the 96 h NOEC was
determined to be 25.0 mg/L. The results are based on the nominal
concentrations (for details see study record).
The second study was performed in order to
evaluate the toxic potential of the hydrolysis product 2,2 -Dimethyl-3
-lauroyloxy-propanal (aldehyde component) the toxic potential of test
item towards freshwater fish, using the species Danio rerio. Three
experiments were performed. As the test item is poorly water soluble,
the “water-accommodated fraction” was tested in the first experiment.
This was done by weighing the nominal load 100 mg/L, adding the
corresponding amount of dilution water and shaking vigorously for 24
hours. As it was not possible to filtrate or centrifuge the resulting
emulsion, the test was performed with the unfiltered emulsion. Seven
fish were exposed to the test item for 96 hours in a static test. After
48 hours, 100 % mortality was observed in the treatment, probably caused
by the undissolved test item. In the control, none of the fish showed
signs of morbidity at the end of the test. The pH and the oxygen values
were normal. Experiments two and three were performed under semi-static
conditions with medium renewal after 24 hours. For the second experiment
a stock solution in acetone was prepared. The treatments 0.1 mg/L and 1
mg/L were prepared by spiking the corresponding amount of dilution water
with this stock solution. The treatment concentration of 1 mg/L was
above maximal water solubility of 0.227 mg/L. Three fish were exposed to
the test item for 96 hours. No mortality was observed in both treatment
groups and the control. Based on these experiments, the third experiment
was performed as a limit-test under semistatic conditions, using a
treatment concentration of 1 mg/L with an acetone-spiked test solution.
Seven fish were exposed to the test item for 96 hours in a static test.
None of the fish died or showed signs of toxicity during the test. The
pH and the oxygen values were normal. The 96 h LC50 was determined at
greater than 1 mg/L and the 96 h NOEC was 1 mg/L. These data were
already submitted in a NONS dossier under Directive 92/32/EEC
(notification number 05 -04 -1922 -00 from 2005 -10 -25) and considered
valid and uncritical from the German Competent Authority (BAUA).
The toxicity of the second hydrolysis
product 3 -aminomethyl-3,5,5 -trimethylcyclohexylamine to Algae was
evaluated according to EU Method C.1. In this 96-h acute toxicity study,
Leucisus idus were exposed to Isophoronediamine at nominal
concentrations of 0 (control), 70, 100, 140, 200 and 280 mg/l under
semi-static conditions. The 96-h LC50 was determined as 110 mg/L. (see
ECHA dissemination homepage).
Due to the physical-chemical properties of
SIKA Hardener LI (fast hydrolysis, low water solubility) it is not
possible to perform standard ecotoxicology tests. It was decided to do
the test by preparing a WAF and base the EC50 and NOEC calculations on
nominal concentrations (justification see study record). A value of 87.2
mg/L was derived. Results from the two hydrolysis products support the
findings and lead to the same environmental classification and labelling
(R52/53 or chronic cat.3, see also biodegradation other ecotoxicological
results). For 2,2 -Dimethyl-3 -lauroyloxy-propanal (aldehyde component)
different tests were done to assess the ecotoxicology towards fish. In
the end it was also not possible to use measured data for EC50
calculations (details see above). As the substance is readily
biodegradable, the LC50 of > 1 mg/L leads to no classification. The data
with -aminomethyl-3,5,5 -trimethylcyclohexylamine with an LC50 of 110
mg/L show a slightly higher LC50 as compared with the parent compound
SIKA Hardener LI, but are in general in the same concentration range.
These data confirm that the classification and labelling and the hazard
assessment of the ecotoxicology of SIKA Hardener LI can be based on the
main study with the product itself.
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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