Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The repeated oral dose toxicity study was performed according to OECD Guideline 407 and GLP principles.

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:
subacute
Species:
rat

Additional information

In a 28 -day oral repeated dose toxicity study, performed according to OECD/EC/EPA test guidelines, rats in groups of 5/sexe/dose were exposed to 0, 150, 450 and 1000 mg/kg bw/day of Radialube 7819 via gavage. These doses were based on a 5 -day range finding study. The following parameters wee evaluated: mortality, clinical signs, fob, body weight, food consumpation, haematology, biochemical parameters, macroscopy, organ weights and microscopy. No toxicologically significant changes were noted in any of the parameters investigated in this study. Therefore, a NOAEL of >=1000 mg/kg bw/day was derived.

Justification for classification or non-classification

Based on the available data, the substance does not have to be classified for repeated dose toxicity according to Directive 67/548/EEC and the CLP Regulation (EC) No 1272/2008.