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EC number: 470-080-3
CAS number: -
In one acute oral toxicity study according
to OECD 401 and GLP, the LD50 in Wistar rats was determined to be
greater than 5000 mg/kg bw. Bodyweight development was not impaired. No
deaths occurred in the study. An acute dermal toxicity study with Wistar
rats also revealed an LD50-value of greater than 5000 mg/kg bw.
In a preliminary in vitro study using the
EpiDerm human skin model test, it was concluded, that
does not show a corrosive potential. Skin irritation/corrosion of
was also investigated in an in vivo test in rabbits. Mean scores over
24, 48 and 72 hours for each animal were 1.0, 0.3 and 0.7 for erythema
and 0.0 for edema. Thus, the test substance is not irritating to the
In a preliminary in vitro HET-CAM test and
an Isolated Chicken Eye (ICE) test
was shown to be not severely irritating to the eye. The negative results
of the in vtro eye irritation tests were confirmed by an in vivo eye
irritation study in rabbits
also showing no indication of eye irritation.
A Local Lymph Node Assay (LLNA) revealed
that the test substance did not induce delayed contact hypersensitivity
and is thus not regarded as skin sensitizer.
The test substance was examined in three
different in vitro mutagenicity studies, all three with and without
metabolic activation. The test item did not induce gene mutations by
frameshift or base-pair substitution in the examined strains in the Ames
tested up to cytotoxic concentrations did not induce structural
chromosome aberrations in Chinese Hamster ovary cells and was therefore
not considered clastogenic in the tested system. Finally the test
substance showed no mutagenic effect in a mammalian cell test, the HPRT
assay. Overall, the substance was considered non genotoxic.
In a 28-day repeated dose toxicity study,
was administered to male and female Wistar rats by gavage at dose levels
of 0 (vehicle control), 100, 300 and 1000 mg/kg body weight per day over
a period of 4 weeks. No treatment-related adverse findings concerning
clinical pathology were noted. Moreover, regarding pathology, there were
no substance-related weight changes, gross lesions or microscopic
findings in male and female Wistar rats observed after 4 weeks of
treatment. In addition, during the recovery period also no effects were
noted. In conclusion, under the conditions of the present study no
substance-related adverse findings were obtained. Therefore, the
no-observed-adverse-effect level (NOAEL) was 1000 mg/kg body weight per
day in both sexes.
In a reproduction/toxicity screening test,
was administered orally via gavage to groups of 10 male and 10 female
Wistar rats (F0 animals) at doses of 100, 300 and 1000 mg/kg body
weight/day (mg/kg bw/d) in order to detect possible effects of the test
substance on the integrity and performance of the reproductive system of
both sexes. The duration of treatment covered a two-weeks premating
period and mating period in both sexes, approximately one week
post-mating in males and the entire gestation period and 4 days of
lactation in females. No test substance-related, relevant findings were
observed in F0 parental animals and F1 pups at all doses applied. Thus,
under the conditions of this reproduction/developmental toxicity
screening test the NOAEL (no observed adverse effect level) for
reproductive performance and fertility was equal to the limit dose of
1000 mg/kg bw/d recommended in the respective guideline for the F0
parental rats. The NOAEL for general, systemic toxicity of the test
substance was also 1000 mg/kg bw/d for the F0 parental male and female
animals. Treatment with the test article did not lead to any
pathomorphological changes with respect to the tissue and organs
examined during necropsy, organ weight determination and light
microscopy. The NOAEL for developmental toxicity in the F1 progeny of
the test substance-treated groups was found to be 1000 mg/kg bw/d.
is a solid at room temperature with a molecular weight of 453.643 g/mol.
The substance is poorly soluble in water (2.5 mg/L). The logPow of the
substance was measured to be 3.5 (HPLC method). A BCF of 9.1 was
measured in zebra fish. The substance has a very low vapour pressure of
< 10-6 hPa at 20°C.
Oral absorption is favoured for molecular
weights below 500 g/mol. Based on the very low water solubility and the
moderate logPow value the substance is not expected to be readily
absorbed via the GI tract and if absorbed to cause very low oral
toxicity as administration in an acute toxicity study caused no
mortalities up to the limit dose of 5000 mg/kg bw.
Based on the low vapour pressure of < 10-6
hPa inhalation exposure is not likely. Thus, it is very unlikely, that
relevant amounts of the substance reach the lung. Furthermore, if the
substance reaches the lung, it is also not very likely that the
substance is taken up rapidly (see discussion based on physical and
chemical parameters for the oral route above). Together, this indicates
low systemic availability after inhalation and if bioavailable, no
systemic toxicity effects via this route of administration.
Similarly, based on physical – chemical
properties, the substance is not likely to penetrate skin to a large
extent due to the low water solubility of 2.5 mg/L. The logPow of 3.4
would favour dermal absorption, but the substance is not sufficiently
water soluble. Furthermore, application of the substance to skin of rats
and rabbits did not cause significant irritation or corrosion nor
systemic effects (mortality) in a skin irritation/corrosion study and an
acute dermal toxicity study up to 5000 mg/kg bw. In addition no skin
sensitizing properties were detected in an LLNA test in mice.
When reaching the body, the substance will
not be easily distributed in body liquids due to its very low water
solubility. Based on its low BCF value of 9.1, the substance is very
unlikely to bioconcentrate in the human body.
Based on the structure of the molecule and
its nature, metabolism in the human body will mainly consist on phase-I
and phase-II metabolising steps, leading to better water solubility for
excretion. Metabolic activation leading to more toxic metabolites is
thus not very likely. This is in compliance with the results obtained in
the genotoxic tests showing no effects with and without metabolising
system. In addition available studies do not indicate any sex difference
with regard to the toxicity of the substance.
Based on the low water solubility and the
relatively high logPow value, excretion via the bile is most likely. In
addition, as the substance has a molecular weight above 300 g/mol the
excretion via the bile is likely, especially if phase-II conjugation
takes place e.g. with formation of glucoronid derivates.
Based on physical-chemical characteristics,
particularly water solubility, octanol-water partition coefficient and
vapour pressure, no or only limited absorption and bioavailability by
the oral, dermal and inhalation routes is expected, which is further
supported by the oral and dermal acute and repeated dose toxicity
studies results. Bioaccumulation is not likely to occur based on the
physical-chemical properties and the determined low BCF value. Excretion
is expected to occur most likely via the faeces. No metabolic activation
to critical metabolites is expected. No sex differences with regard to
toxicity are expected based on data from repeated dose toxicity tests.
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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