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EC number: 700-071-4
CAS number: 932742-30-8
A repeated toxicity oral study with the test item SIKA Hardener LI was performed according to OECD guideline 408. The derived no observed adverse effect level (NOAEL) was 300 mg/kg bw/day. Testing via inhalation and dermal routes was waived, according to the REACH Regulation (EC) No 1907/2006/EEC, Annex VIII, 8.6.1.
Repeated dose toxicity: oral
A 90-day oral (gavage) toxicity study was
performed with SIKA Hardener LI in male and female Hsd.Brl.Han: Wistar
according to OECD Gudeline 408. The test item was administered orally to
the test animals (n=15 animals/sex in the control and high dose groups,
n= 10 animals/sex in the low and middle dose groups) once a day at 0
(vehicle control), 1000, 300 and 100 mg/kg bw/day doses corresponding to
concentrations of 200 mg/mL, 60 mg/mL and 20 mg/mL, applied in a dose
volume of 5 mL/kg bw for 90 days. 5 animals/sex in the control and high
dose groups were observed without administration for four weeks
(recovery observations). Polyethylene glycol 400 was used as vehicle.
Animals were observed for mortality twice a day in the course of the
study. Daily general clinical observations and weekly detailed clinical
observations were performed. A functional observation battery was
conducted in the last week of treatment. The body weight and food
consumption were measured and evaluated weekly. Clinical pathology
examinations (including hematology and clinical chemistry) and gross
pathology were conducted one day after the last treatment and at the end
of the recovery period. The absolute and relative weights of selected
organs were determined. Full histopathology was performed on the
preserved organs or tissues of the animals of the control and high dose
groups including recovery groups. Thymus showing macroscopic changes was
examined histologically in one male animal of 300 mg/kg bw/day group.
SIKA Hardener LI caused salivation (male and female), changes in white
blood cell count (females) and in spleen weight (females) at 1000 mg/kg
bw/day in Hsd.Brl.Han: Wistar rats after the consecutive 90-day oral
(gavage) administration. At 300 mg/kg bw/day, salivation was observed in
some male and female animals during the treatment period. Slight changes
in the white blood cell count and spleen weight relative to body weight
in female animals were judged to be toxicologically not relevant. At 100
mg/kg bw/day, there was no test item related effect. Based on these
observations the No Observed Adverse Effect Level (NOAEL) was determined
as follows: NOAEL: 1000 mg/kg bw/day for male animals; NOAEL: 300 mg/kg
bw/day for female animals.
Additionally, a second repeated dose
toxicity study (supporting study) is available: A 28-day oral (gavage)
toxicity study was performed with SIKA Hardener LI in male and female
CRL:(WI) BR Wistar rats according to EC method B.7 and OECD guideline
407. Dose levels administered in this study were selected based on data
obtained during a 14-day dose-range-finding toxicity study. The test
item was administered to control and treatment groups (n= 5 animals per
group and sex) at doses of 0, 50, 350 and 1000 mg/kg bw/day doses
levels, at a 4 mL/kg bw in PEG 400. Stability and homogeneity of test
item in the vehicle was confirmed. Administration of SIKA Hardener LI
did not lead to any toxicologically adverse effects at dose levels of
50, 350 or 1000 mg/kg bw/day. There were no changes in the animal
clinical condition, body weight or food consumption. No treatment
related effects noted in clinical pathology (haematology, coagulation
and clinical chemistry). There were no macroscopic or microscopic
findings, or changes in the organ weights. In conclusion, under the
conditions of this study, the no observed effect level (NOEL) for SIKA
Hardener LI was 1000 mg/kg bw/day (limit dose).
Repeated dose toxicity: dermal
Repeated dose toxicity testing via the
dermal route was waived, according to the REACH Regulation (EC) No
1907/2006, Annex VIII, 8.6.1.
Repeated dose toxicity: inhalation
Repeated dose toxicity testing via
inhalation was waived, according to the REACH Regulation (EC) No
1907/2006, Annex VIII, 8.6.1.
Based on a chronic repeated oral toxicity
study, test item SIKA Hardener LI was not classified and labelled
according to Directive 67/548/EEC (DSD) and to 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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