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EC number: 203-804-1
CAS number: 110-80-5
rabbit (Gross E): albuminuria, hematuria (see also more details in
publication: Gross E., cited in Patty F.A., 1963)
Results subchronic oral gavage rat (13 weeks):
At doses of 50, 100 and 100/400 µL/kg/day (increased dosage from 100 to
400 µL/kg at day 59 of the study period) no treatment related systemic
changes in the analysed organs were observed. The administration of 200
µL/kg/day resulted in all 5 male rats in obvious changes in the testes
(interstitium loosened oedematously). In the tubuli there was a lack of
the last ripening step from the normally arranged germinal epithelium to
the spermatocytes. In the spleens of all animals haemosiderin deposits
were observed. Nearly same results were observed in the dose group
200/800 µL/kg/day (increased dosage from 200 to 800 µL/kg at day 59 of
the study period).
Results subchronic oral gavage (gelatine capsules) dog (13 weeks):
At doses of 50 and 100 µL/kg/day no macroscopic nor histological
treatment related systemic changes in the analysed organs were observed.
At 200 µL/kg/day changes of the testes in the 3 male dogs were seen. In
2 male and one female slight changes were observed at the kidneys.
Summarised results (rat and dog):
Mortalities: none (13 wk rat study; 11d dog study; 13 wk dog study)
Symptoms: none (13 wk rat study; 11 d dog study; 13 wk dog study)
Body weight development: at dosage including level 800 µl/kg/d from day
60 on slightly retarded for males (13 wk rat study); 1 and 3 kg, 2 and
2.6 kg (11 d dog study); no effect (13 wk dog study)
Feed consumption: at dosage including level 800 µl/kg/d from day 60 on
reduced (13 wk rat study); not measured (11 d dog study); no effects (13
wk dog study)
Hemoglobin and hematocrite:
no effect (11 d dog study)
13 wk rat study:
13 wk dog study:
Results on developmental toxicity:
The administration of 0, 12.5, 25, 50, 100, 200, or 400 µL/kg/day during
gestation (day1 to day 21) resulted in a NOEL for the rat of 25
µL/kg/day. As this value was the lowest according to the complete study
results of Stenger et al. (1971), the author of this IUCLID dossier
considered this low value also as the overall NOEL for this endpoint.
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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