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EC number: 203-041-4
CAS number: 102-60-3
Repeated dose oral (non-guideline study): 90-days feeding study in Harlan Albino rats, 70-3770 mg/kg bw test substance; NOEL = 720 mg/kg bw (Hilltop Research Institute E-151, 1956)
Repeated dose oral (non-guideline study): 90-days feeding study in Sprague-Dawley rats, 500 mg/kg bw test substance; NOAEL = 500 mg/kg bw (MJ Dunphy, 1991)
Repeated dose oral (GLP & OECD 422): gavage study in Wistar rats, 0-1000 mg/kg bw test substance; NOAEL = 300 mg/kg bw (BASF SE 95R0628/04108; 2009)
To assess toxicity of ethylenediamine, +4PO upon subacute oral exposure,
Wistar rats of both sexes were administered with 0, 100, 300, 1000 mg/kg
bw test substance (vehicle: water) by gavage for 30 (males) or 49
(females) days in a GLP and OECD 422 guideline study (BASF,
95R0628/04108, 2009). Adverse effects were exclusively seen in the high
dose group. All animals treated with 1000 mg/kg bw ethylenediamine, +4PO
displayed vacuolisation of the epithelial cells of the choroid plexus of
the lateral ventricles in the brain. Detailed behavioural and
neurological examinations of these animals did not reveal any
physiological consequences of this vacuolisation. Although the further
impact of the observed phenomenon in the choroid plexus is unclear, it
is considered to be an adverse effect. However, similar effects were not
recorded for the other dose groups. No mortalities occured and
parameters of clinical chemistry and haematology did not show treatment
related changes. No gross lesions were reported during necropsy. Thus,
under the study conditions chosen, a NOAEL of 300 mg/kg bw was
derived for general sytemic toxicity.
In a 90-days repeated dose feeding study, Harlan strain Albino rats were
administered with 70, 210, 720, 2170 and 3770 mg/kg bw ethylenediamine,
+4PO (Hill Top Research Institute E-151; 1955). At higher dose levels (≥
2170 mg/kg bw) rats displayed cellular degeneration and necrosis in the
liver. The NOEL is 720 mg/kg bw. In an additional 90-days feeding
study, Sprague-Dawley rats were dosed with 500 mg/kg bw ethylenediamine,
+4PO (MJ Dunphy, 1991). No adverse observations were reported. Thus, a
NOAEL of 500 mg/kg bw was determined. However, in none of the 90 -days
studies, the brain was examined during necropsy or histopathology. Taking
into account this limitation, the results of the Hill Top study and the
report of MJ Dunphy are in line with the BASF repeated dose study
The available studies
are considered reliable and suitable for classification purposes under
67/548/EEC and 1272/2008/EEC. In conclusion, ethylenediamine, +4PO does
not require classification.
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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