Registration Dossier

Diss Factsheets

Administrative data

Description of key information

A repeated dose/reproductive toxicity screening study has been performed on rosin, fumarated.  Any toxicity seen was insignificant and probably due to poor palatability of the substance being investigated. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
250 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

A repeated dose/reproductive toxicity screening study has been performed on a representative rosin adduct. As with the studies on rosin, rosin esters and rosin adduct esters any toxicity seen was insignificant and probably due to poor palatability of the substance being investigated. No clear target organ could be identified in as study in which the substance was administered in the diet. The NOAEL is taken as 250 mg/kg bw/d. The 'weight of evidence' is that large quantities of rosin and and chemically modified rosins, when administered in the diet, are unpalatable.

Justification for classification or non-classification

Not classified for specific target organ toxicity – repeated exposure according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 orUN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Categories Display