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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

To determine toxicity to reproduction and prenatal development of ethylenediamine, +4PO, the test substance was administered to Wistar rats by gavage (dose levels: 0, 100, 300 and 1000 mg/kg bw; vehicle: water). Treatment started 14 days before mating. In total, males were treated for approximately 30 days and females for 49 days. Females and their pups were sacrificed 4 days post partum. Signs of developmental or reproductive toxicity were not reported at any dose level (BASF, 95R0628/04108, 2009).

Thus the NOAEL for developmental toxicity and toxicity to reproduction is 1000 mg/kg bw.

Short description of key information:

Reproduction / Developmental Toxicity Screening Test (GLP & OECD 422): NOAEL = 1000 mg/kg bw for developmental toxicity

Effects on developmental toxicity

Description of key information

Reproduction / Developmental Toxicity Screening Test (GLP & OECD 422): NOAEL = 1000 mg/kg bw for developmental toxicity

Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

For details see record "effects on fertility".

Justification for classification or non-classification

The available study is considered reliable and suitable for classification purposes under 67/548/EEC and 1272/2008/EEC. In conclusion, ethylendiamine, +4PO does not require classification for developmental toxicity and toxicity to reproduction.