Registration Dossier
Registration Dossier
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EC number: 915-657-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In vitro skin corrosivity and skin irritation studies were performed with the closely related substance Dresinate 835 A (Na-salt, Reaction mass of Resin acids and Rosin acids, hydrogenated, sodium salts and sodium [1R-(1a,4aß,10aa)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylate). An in vivo skin irritancty test was performed on the potassium salt of hydrogenated rosin, with no evidence for irritancy .
An invalid in vitro study eye irritation study was performed with the closely related substance Dresinate 835 A (Na-salt, Reaction mass of Resin acids and Rosin acids, hydrogenated, sodium salts and sodium [1R-(1a,4aß,10aa)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylate). A valid in vivo rabbit irritation study was 'read across' from the potassium salt of hydrogenated rosin.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
In vitro studies were performed for skin and eye irritancy.
The skin corrosion/irritation test showed that the test item was irritant to skin, the eye irritation test showed that the test item was severely damaging/corrosive to eyes. The skin irritation test appear acceptable, the eye irritation test is invalid due to inappropriate dose levels. Both in vitro skin corrosion and in vivo skin irritation tests and an in vivo eye irritation test are available for the potassium salt of hydrogenated rosin. The in vivo skin irritancy test was negative, the eye irritation test indicates that the substance should be classified as irritating.
A justification for read-across is given in section 13, Assessment reports. The in vitro reports and the in vivo reports on skin and eye irritancy are evaluated in the evaluation report given in section 13.
Effects on eye irritation: irritating
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
According to the results obtained from the in vitro skin and eye irritation/corrosion studies the test item has to be classified as "R38 Irritating to skin" (EU-GHS: Skin irritation Cat.2) and as "R36 Irritating to eyes" (EU-GHS: Irritating to eyes Cat. 2).
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