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EC number: 444-810-6
CAS number: -
This study was performed to assess the acute oral toxicity of
CP-163,625-BV to the rat. The method followed to be compliance with that
described in: EEC Methods for the determination of toxicity, Annex to
Directive 92/69/EEC (OJ No. L3 83A, 29.12.92), Part B, Method B.1 bis.
Acute toxicity (oral) - fixed dose method. OECD Guideline for Testing of
Chemicals No.420 'Acute Oral Toxicity - Fixed Dose Method' Adopted 17
July 1992. A group of ten fasted rats (five males and five females)
received a single oral gavage dose of the test substance, formulated in
1% w/v aqueous methylcellulose and administered at a dose level of 500
mg/kg bodyweight. This dose level was chosen after review of results
from the preliminary study and in compliance with the test guideline. As
a result of a mortality at 500 mg,/kg and after further preliminary
investigations a further group of ten rats (five males and five females)
was dosed at 50 mg/kg bodyweight. One male dosed at 500 mg/kg died
during the study. All remaining animals treated at 500 mg/kg and all
animals subsequently dosed at 50 mg/kg were killed as scheduled at study
termination (Day 15) and subjected to a macroscopic examination.
Clinical signs of reaction to treatment characterised by piloerection
(first evident in all rats within six minutes of dosing) was seen in all
rats, and accompanied at later intervals on Day 1 or thereafter by
hunched posture, waddling/unsteady gait, lethargy, abnormal respiration,
pallid extremities, body tremors, blue/cold extremities and dull
colouring to eyes (notable in all rats at 500 mg/kg). Also observed in
one or more animals were partially closed eyelids, walking on toes,
increased lacrimation, increased sensitivity to touch, protruding eyes
and prostration. Recovery in all surviving rats was complete on Day 3. A
notably low bodyvveight gain was observed in one female (No. 16, 500
mg/kg) on Day 15. All remaining rats were considered to have achieved
satisfactory bodyweight gains during the study. Macroscopic examination
of the one decedent in the main study revealed congestive changes to the
majority of tissues and organs with fluid contents in the stomach and
along the alimentary tract. No abnormalities were detected in any of the
remaining animals killed at study termination (Day 15). In the main
phase of this study, the non-lethal (discriminating) oral dose to rats
of CP-163,625-BV was demonstrated to be 50 mg/kg bodyweight. As a result
of mortality among rats dosed at 500 mg/kg bodyweight, in accord with EU
hazard classification CP-163,625-BV will require labelling with the risk
phrase R22 Harmful "if swallowed", in accordance with Commission
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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