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EC number: 617-901-5
CAS number: 866607-35-4
In a combined 28 -day repaeated dose toxicity study with the
reproduction/developmental toxicity screening test, the test substance
was administered daily to rats at dose levels up to 1000 mg/kg
bodyweight/day (OECD 422; Mounier R, 2017). The parental and
reproduction NOAEL was established as at least 1000 mg/kg/day.
The test item is not to be classified as reproductive toxicant according
to CLP Regulation.
Analysis of dose preparations
All formulations at 22, 66 and 200 mg/mL of test substance in vehicle
(propylene glycol), including the vehicle, used on the first day of
treatment of the main study, were in agreement with acceptance criteria.
The formulations at 22 and 200 mg/mL were homogenous. The deviations
from the nominal concentrations ranged from -2.0% to -0.8% , and the RSD
No significant amount of test item was detected in the vehicle sample.
Toxicity to reproduction
A combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test was performed in
rats, in which male and female rats were exposed to 0 (vehicle), 110,
330, and 1000 mg/kg bw/day via gavage (OECD 422; Mounier R, 2017).
There were no adverse parental, reproduction and developmental toxicity
at any dose level.
The vehicle used was propylene glycol and the test solutions were
No treatment-related changes were noted in any of the parental
parameters investigated in the study (i.e. clinical appearance,
functional observations, body weight, food consumption, clinical
laboratory investigations, macroscopic examination or organ weights, and
microscopic examination). Minimal hypertrophy of the zona glomerulosa of
the adrenal glands was seen in a few animals at 1000 mg/kg/day. In the
absence of clinical disease, adrenal weight changes, clinical chemistry,
in particular electrolyte changes, this finding was not considered to be
of any toxicological significance and might reflect normal background
physiological variations in the appearance of this zone of the cortex.
In addition, as the outermost zone, it is prone to handling artefacts.
No treatment-related changes were noted in any of the reproductive or
developmental parameters either (i.e. mating, fertility, pre-coital
interval, number of implantations and histopathological examination of
reproductive organs, gestation, viability and lactation indices,
gestation index and duration, parturition, sex ratio, maternal care and
early postnatal pup development consisting of mortality, clinical signs,
body weight, anogenital distance (PND 1), areola/nipple retention (PND
13 males), T4 thyroid hormone levels (PND 13) and macroscopy.
The Parental, Reproduction and Developmental NOAEL were established as
at least 1000 mg/kg bw/day.
In a combined 28 -day repeated dose toxicity study with the
reproduction/developmental toxicity screening test (OECD 422; Mounier R,
2017) a developmental NOAEL of 1000 mg/kg body weight/day was
The test substance is not classified as reproductive toxicant according
to the CLP Regulation.
Based on the results of the OECD 422 study, the following No Observed
Adverse Effect Levels (NOAEL) were derived:
Parental NOAEL: at least 1000 mg/kg.
Reproduction NOAEL: at least 1000 mg/kg.
Developmental NOAEL: at least 1000 mg/kg.
Therefore, the substance is not to be classified as reproductive
toxicant according to CLP Regulation.
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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