Registration Dossier
Registration Dossier
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EC number: 696-130-6 | CAS number: 1364681-45-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 316 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Additional information
A subacute oral toxicity study followine OECD guideline 407 including a 14 -day recovery period is available (ARC 2007).
The test item used is a mixture of dehydrogenated and partially hydrogenated gum rosin. The range of organic acids in the test item is similar to that from which the salt form of the target substance is formed. In both cases (test substance and target substance) the cumulated double bonds of the starting rosin have been transformed into either isolated double bonds or aromatic rings. Further details on read-across are provided at the end of the chemical safety report. The only effect observed was for females of the high dose group (1000 mg/kg bw) was centrilobular cytoplasmatic vacuolization of hepatocytes of females. It was still present after the 14-day recovery sacrifice, but not accompanied by changes in organ weights or clinical chemistry parameters.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. No serious irreversible effects were observed at dose levels of less than 150 mg/kg bw upon subacute exposure. As a result the substance is not considered to be classified for repeated dose toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. There were no significant toxic effects at doses of less than 300 mg/kg bw upon subacute oral exposure in rats. As a result the substance is not classified for repeated dose toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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