Registration Dossier

Administrative data

Description of key information

In conclusion, administration of Alkenes, C11-12, hydroformylation products, distn. residues by once daily oral gavage was well tolerated in rats at levels of 100, 300 and 1000 mg/kg/day. Based on the results, the no-observed-effect level (NOEL) for males was considered to be 1000 mg/kg/day. Due to reversible changes in the liver weights in females the no-observed-adverse-effect level (NOAEL) was considered to be 1000 mg/kg/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Well conducted OECD 408 guideline study conducted according to GLP

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In conclusion, administration of Alkenes, C11 -12, hydroformylation products, distn. residues by once daily oral gavage was well tolerated in rats at levels of 100, 300 and 1000 mg/kg/day. Based on the results, the no-observed-effect level (NOEL) for males was considered to be 1000 mg/kg/day. Due to reversible changes in the liver weights in females the no-observed-adverse-effect level (NOAEL) was considered to be 1000 mg/kg/day.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The design of this study was based on the study objectives, the overall product development strategy for the test item, and the study design guidelines:

Justification for classification or non-classification

The available data on repeated dose toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC.