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EC number: 442-300-8
CAS number: -
Oral administration of the test item
by gavage to male and female Wistar rats for 3 months caused no signs of
systemic toxicity up to the highest dose level tested (1000 mg/kg bw/d).
Therefore, under the conditions of the present study the no observed
adverse effect level (NOAEL) was 1000 mg/kg bw/d for male and female
In the key study the test item was
administered by gavage to groups of 10 male and 10 female Wistar rats at
dose levels of 0 (test group 0), 100 (test group 1), 300 (test group 2)
and 1000 mg/kg bw/d (test group 3) over a period of 3 months (GLP, OECD
guideline 408). With regard to clinical examinations, no signs of
general systemic toxicity were observed in any of the test groups.
Concerning clinical pathology no treatment-related, adverse effects were
observed up to a dose of the test substance of 1000 mg/kg bw/d.
Regarding pathology, there was a significant increase in kidney weights
in females of test group 3 (1000 mg/kg bw/d). A treatment-related effect
seems unlikely due to a missing histopathological correlate. It
therefore was regarded to be not an adverse finding. All other findings
occurred either individually or were biologically equally distributed
over control and treatment groups. They were considered to be incidental
or spontaneous in origin and without any relation to treatment. In
conclusion, the oral administration of the test item by gavage to male
and female Wistar rats for 3 months caused no signs of systemic toxicity
up to the highest dose level tested (1000 mg/kg bw/d). Therefore, under
the conditions of the present study the no observed adverse effect level
(NOAEL) was 1000 mg/kg bw/d for male and female Wistar rats.
In a supporting subacute study
performed according to OECD 407, the test material was administered by
gavage to three groups, each of five male and five female Sprague-Dawley
Crl:CD® (SD) IGS BR strain rats, for twenty-eight consecutive days, at
dose levels of 150, 500 and 1000 mg/kg/day. A control group of five
males and five females was dosed with vehicle alone (Polyethylene glycol
400). Two recovery groups, each of five males and five females, were
treated with the high dose (1000 mg/kg/day) or the vehicle alone for
twenty-eight consecutive days and then maintained without treatment for
another 14-day period. Increased salivation was detected up to ten
minutes after dosing and, on occasion, up to one hour after dosing, in
animals of either sex treated with 1000 mg/kg/day from Day 7 onwards.
Increased salivation was also detected in animals treated with 500
mg/kg/day but was confined to two animals on Days 26 and 27 only. Such
observations are often recorded following the oral administration of an
unpleasant tasting and/or locally irritant test material formulation
and, in isolation, are considered not to be indicative of systemic
toxicity. Microscopic examination of liver sections revealed a higher
severity and incidence of glycogen storage type hepatocyte vacuolation
for animals of either sex treated with 1000, 500 and 150 mg/kg/day. A
clear dose response was not apparent. Glycogen storage is a highly
variable condition in the liver of laboratory maintained rats and any
relationship to treatment tends to be entirely adaptive in nature. In
the absence of any degenerative or inflammatory changes, this condition
is almost certainly adaptive. Absolute and relative liver weight was
elevated for 1000 mg/kg/day females but values were within normal
ranges. This effect was reversible after 14 days without treatment.
There were also no blood chemical changes to suggest an adverse liver
effect. No adverse effect on physical condition was evident in treated
animals with normal bodyweight development and food consumption evident
throughout the study. The changes seen in this study were, therefore,
considered to be entirely adaptive and did not represent an adverse
health effect at any of the dose levels examined.
Labelling, and Packaging Regulation (EC) No 1272/2008
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. As a result
the substance is not considered to be classified for repeated dose
toxicity under Regulation (EC) No 1272/2008, as amended for the eighth
time in Regulation (EU) No 2016/218.
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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