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EC number: 419-480-1
CAS number: -
This study is read across to the Structural Analogue 01, which is
considered structurally equivalent to the substance to be registered.
Justification for this read across is detailed below under "attached
As can be seen from the results reported in the preceding section, the
oral administration of the Structural Analogue 01 at a dose of 1000
mg/kg did not lead to any impairment of feed consumption or body-weight
gain of the dams. The black or blue discoloration of the faeces in all
dams of and the red discoloration of the urine in most of the dams of
the compound group is due to the excretion of the dye. Likewise, the
grey-green discoloration of the renal cortex detected at autopsy in 13
dams is compound-related. The renal pelvic dilatation noted in one dam
of the compound group is likewise spontaneous (this disorder is known to
occur spontaneously in the rat strain used here; compare the finding in
one control dam).
The intrauterine development of the foetuses was likewise unaffected by
the administration of the Structural Analogue 01. The foetuses delivered
in the dose group were normally developed and did not differ from the
control foetuses in terms of body weight and length. The placentas of
the foetuses were also largely unremarkable.
The morphological examination of the offspring of the dams treated with
the Structural Analogue 01 did not reveal any malformations. The
following changes, which were detected in individual or some foetuses
from the compound group at autopsy or body cross-section examinations,
are to be regarded as minor anomalies: haemorrhages in the brain or in
various parts of the body; caudalward displacement of both kidneys;
dilatation of renal pelves or ureters. These changes also occur in
control foetuses, so a connection with the administration of the
compound is unlikely. Other minor anomalies were: longitudinally
displaced, dislocated, fragmented sternebrae, wavy or thickened ribs
(detected in several foetuses); fragmented 13th thoracic vertebral
centre and short length of both humeri (one foetus each); flexion and
short length of one or both scapulae (two foetuses). However, the anlage
of a 14th thoracic vertebra with a short analogous rib pair in one
foetus and the short rib anlage, uni- or bilaterally, at the 1st lumbar
vertebra detected in numerous foetuses are to be classified as
variations. The number of foetuses affected by the stated alterations
lay in the range of the spontaneous rate, with the exception of the
blood accumulation in the vicinity of the stomach and the displacement
of both kidneys. However, these change only affected one foetus each so
that a causal connection with the administration of Structural Analogue
01 is unlikely here also.
The skeletons of the foetuses of the compound group did not reveal any
delayed ossification which could be rated as a retardation. The poor or
missing ossification of cranial bones, sternebrae, 2nd or 5th metacarpal
bone, third phalanx of the digits of the two hind limbs and the
ossification of fewer than two caudal vertebrae may be classified as a
retardation, but in this study these findings reflect the normal stage
of ossification of the skeleton in this phase of development.
In summing up, it can be seen from these findings that Structural
Analogue 01 administered to rats in oral doses of 1000 mg/kg under the
chosen study conditions is not toxic to dams or their conceptuses.
Likewise, no indication of any teratogenic effect of the test compound
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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