Registration Dossier
Registration Dossier
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EC number: 700-751-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
A repeated dose/reproductive toxicity screening study has been performed on CAS 65997-04-8 rosin, fumarated which is the an analogous substance fo Ca/Mg salt of rosin, fumarated. As with similar 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.
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
Rosin (a UVCB) reacts with maleic anhydride (or maleic acid) and fumaric acid to form adducts. The initial reaction is a Diels-Alder reaction. Irrespective of starting material the eventual product is maleopimaric acid anhydride (an acid anhydride often referred to as maleopimaric acid. The reaction with fumaric acid is slower than that with maleic anhydride and the conversion from fumaropimaric acid to the maleopimaric acid anhydride is thought to be partial. Thus maleated rosin and fumarated rosin are treated as separate, but related substances and are considered sufficiently similar to allow ‘read across’ from one to the other. This category justification was considered acceptable by the US Environment Protection Agency their High Production Volume Challenge Program. The inclusion of adducts of hydrogenated rosin and formaldehyde treated rosin and the salts of adducts formed from rosin, hydrogenated rosin and formaldehyde treated rosin in this family is based on the grouping used for the rosin and rosin salts category.Thus, according to the provisions of Annex XI, 1.5 (grouping of substances and 'read across') and the Guidance 'read across' can be undertaken.
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 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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