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EC number: 701-281-9
CAS number: -
Acute oral toxicity:
In a recent study
(2010), performed according to actual guidelines, an LD50 of >5000 mg/kg
bw was determined. The test substance was administered in deionised
water. All animals showed signs of reduced well-being fromuntilp. a.
This term encompasses unspecific alterations, like sedation, apathy,
piloerection, hunched posture or closed eyes, in single or multiple
occurrence. There were no other adverse effects noted in the animals.
In a recent study
(2010), performed according to actual guidelines, the LD50 was >2000
mg/kg bw and no adverse effects were noted in the animals. No indication
for a dermal absorption was obtained from this study.
Results of a Combined
Repeated Dose / Reproduction /Developmental Toxicity Screening Study
give some indication for an absorption of the test substance in the
gastrointestinal tract and a distribution in the body:
In the livers of high
dosed males a slight centrolobular hepatocyte cytoplasmatic basophilia
was noted. This is interpreted as an indicator of enzyme induction, and
is taken as an adaptive response, although not supported by clinical
chemistry parameters. A slight proliferation of the limiting ridge of
the stomach without signs of inflammation in almost all high dosed males
is interpreted as a slight local irritation by the test substance.
All test substance
related findings were present only in a low grade of severity and never
No-observed-effect-level (NOEL) of the test substance was at 316 mg per
kg body weight and day for males and at 870 mg per kg body weight and
day for females, based on the effects described above. No severe toxic
effects were noted even at a dose of 870 mg/kg.
In a Combined Repeated
Dose / Reproduction /Developmental Toxicity Screening Study (see also
above) no effects on reproduction parameters and on the offspring were
noted at doses up to 870 mg per kg body weight and day.
The test item gave
positive results in one bacterial gene mutation test (positive for three
out of five Salmonella strains) and in one in one mammalian cytogenetic
study, regardless whether tested without or with the addition of
metabolizing enzymes. Both studies were performed under GLP and
according to current guidelines. The test item was mutagenic and
clastogenic in the two in vitro tests.
Absorption of the test
substance in the gastrointestinal tract and a distribution in the body
was demonstrated by a Combined Repeated Dose / Reproduction
/Developmental Toxicity Screening Study with the test item. Indications
for systemic effects were also seen after single oral administration
(acute oral toxicity).
No systemic effects
were noted after single dermal exposure to the test substance (acute
dermal toxicity study). The low partition coefficient n-octanol/water
(1.67) and the high water solubility (>100 g/L) do not favour a
penetration of the test item through biological membranes. The potential
for bioaccumulation is considered to be low, based on the low partition
coefficient and the ready biodegradability.
differences occurred in the two mutagenicity studies with and without
the addition of a metabolising system. Therefore no indication of the
importance of the metabolism of the test item was obtained from these
No information is
available on excretion of the test item.
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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