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Administrative data

Description of key information

A 13 -week repeated oral dose (dietary) study (OECD & GLP) was conducted to determine the effects of prolonged exposure on rats of the test material DEGDB.  Groups of ten rats were dosed by dietary administration with DEGDB for a period of 13 weeks at levels 0 (untreated diet control), 250, 1000, 1750, and 2500 mg/kgbw/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

A 13 -week repeated oral dose (dietary) study was conducted to determine the effects of prolonged exposure on rats of the test material DEGDB. Groups of ten rats were dosed by dietary administration with DEGDB for a period of 13 weeks at levels 0 (untreated diet control), 250, 1000, 1750, and 2500 mg/kg/day. Additional rats were dosed at 0 and 2500 mg/kgbw/day to allow for an assessment of recovery from treatment for four weeks after dosing. No findings of toxicological importance were detected in this study at a dosage of 1000 mg/kg/day or below. Dosages of 1750 or 2500 mg/kg/day were tolerated (with one exception - a single mortality at 2500 mg/kg/day) but induced clinical findings changes in blood parameters, minor treatment-related pathology and/or adverse effects on bodyweight gain. When selected animals previously receiving 2500 mg/kg/day were maintained off dose for 4 weeks all treatment related changes showed evidence of or complete recovery.

Justification for classification or non-classification

The result of the subchronic test (90 day rat oral) revealed a NOAEL of 1000 mg/kg bodyweight/day. Therefore, according to the criteria laid down in Council Directive 67/548/EEC (DSD) the test item DEGDB, is considered as posing no danger of serious health damage by prolonged oral exposure and is not classified. Furthermore DEGDB is not classified under the CLP.