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EC number: 700-071-4
CAS number: 932742-30-8
SIKA Hardener LI was tested in an acute oral toxicity study according to EU method B.1tris and OECD guideline 423. No treatment related effects were observed up to dose levels of 2000 mg/kg bw. The LD50-value was greater 2000 mg/kg bw and the NOEL 2000 mg/kg bw. SIKA Hardener LI was tested in an acute dermal toxicity study according to EU method B.3 and OECD guideline 402. No treatment related effects were observed up to dose levels of 2000 mg/kg bw. The LD50-value was greater 2000 mg/kg bw and the NOEL 2000 mg/kg bw. Testing via the inhalation route was waived, according to REACH Regulation (EC) No 1907/2006, Annex VIII, 8.5.2.
Acute toxicity oral
The acute toxicity oral of SIKA Hardener LI
was tested according to EU method B.1tris and OECD guideline 423 (limit
test). Two groups of three female Wistar rats were treated with SIKA
Hardener LI by a single oral (gavage) administration at a dose level of
2000 mg/kg bw using Polyethylene glycol as a vehicle. The concentration
of Polyethylene Glycol in formulations was 200 mg/mL administered by a
constant treatment volume of 10 mL/kg bw. No mortalities were recorded.
No clinical signs were observed under the duration of the 14 days
observation period. The body weight gain of the animals was considered
to be normal with no indication of test item related effect. The
macroscopic examination revealed some minor alterations as mottled pale
areas in the liver, diffuse dark red discolouration of the lung, dark
focus on the lung and collapsed lung. As these changes were considered
to be agonal or incidental it was concluded that under the conditions of
the present study, a single oral administration of the test item SIKA
Hardener LI, at a dose level of 2000 mg/kg bw did not cause any
treatment related adverse effects. Therefore the acute oral LD0 and LD50
values of SIKA Hardener LI were determined 2000 mg/kg bw and greater
than 2000 mg/kg bw .
Acute toxicity dermal
SIKA Hardener LI was tested in an acute
dermal toxicity study according to EU method B.3 and OECD guideline 402
(limit test). Five male and five female Wistar rats were treated with a
single administration at a dose level of 2000 mg/kg bw in its original
form for 24 h in a semi-occlusive manner. No mortalities occurred,
neither in male nor in female rats during the 14 days observation
period. Behaviour and general state of animals were considered to be
normal. All pathological findings were considered incidental changes
with no indication of test item related effects. Thus, under the
conditions of this study, SIKA Hardener LI did not induce any test item
related adverse effects. The acute dermal LD0 and LD50 -values of SIKA
Hardener LI were considered to be 2000 mg/kg bw and greater than 2000
mg/kg bw, respectively.
Acute toxicity inhalation
Additional testing by inhalation route is
not applicable as an acute oral toxicity study and an acute dermal
toxicity study were performed. According to the REACH Regulation No.
1907/2006, Annex VIII, 8.5 only two acute dose toxicity studies are
required, with test item administration via the most appropriate route.
Based on results obtained in acute toxicity
studies SIKA Hardener LI was not classified and labelled according to
Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
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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