Registration Dossier
Registration Dossier
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EC number: 500-451-8 | CAS number: 160901-14-4
Endpoint summary
Administrative data
Description of key information
Capable of causing sensitisation by skin contact.
Not expected to induce or elicit respiratory sensitization, with low potential for exposure due to low volatility.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No key or supporting skin sensitisation data is available for Fatty acids, tall oil, oligomeric reaction products with maleaic anhydride and rosin, calcium, magnesium salts. However, data is available from tests conducted using a structural analogue Rosin, maleated. This information is summarised below.
In a skin sensitization study using the Local Lymph Node Assay, groups of mice were given daily applications of 0%, 0.5%, 5%, or 50%(w/v) Rosin, maleated in acetone/olive oil 4:1 (Safepharm Laboratories Ltd, 2002). The pooled Stimulation Index was 1.91, 22.84 and 19.27, respectively. Based on the results, Rosin, maleated was a skin sensitizer in mice in an OECD 429 compliant study.
In another supporting study conducted using the Buehler method, 20 guinea pigs were induced weekly by topical administration of 80% concentration of Rosin, maleated in olive oil (Eurofins Product Safety Laboratories, 2007). In addition, 10 guinea pigs assigned to control groups received only the vehicle during the induction period. Along with the test animals, the controls (previously not induced with the test substance) were challenged topically with concentrations of 5% of the test substance in the vehicle. Skin examinations at 24 hours after the completion of the challenge exposure resulted in a positive response for 16 of the 20 animals in the treatment group. Therefore, Rosin, maleated was considered to be a skin sensitizer to guinea pigs.
In a study using Rosin, maleated (CAS 8050-28-0) in olive oil, male guinea pigs (20 males per test group and 10 control males) were tested using the Guinea Pig Maximazation Test (Central Toxicology Laboratory, 1997). Test animals were induced by intradermal injections with a 0.003% w/v concentration. In addition, these guinea pigs were topically induced with a 30% concentration of the test substance in olive oil. Along with the test animals, two groups of control animals (10 per group), previously not induced with the test substance, were challenged topically for 24 hours with concentrations of 10 or 30% of the test substance in olive oil. Skin examinations at 24 hours after the completion of the challenge exposure indicated that 15 of the 19 animals in the treatment group challenged with 10% and all treated animals challenged with 30% exhibited a positive response. Based on the results of this study, Rosin, maleated was considered to be a skin sensitizer to guinea pigs.
Justification for Read Across
Fatty acids, tall oil, oligomeric reaction products with maleaic anhydride and rosin, calcium, magnesium salts and Rosin, maleated are UVCB homologues formed by the reaction of levoprimaric acid present in both with maleic anhydride or maleic acid, with additional neutralisation of fatty acids present in the former to give divalent calcium, magnesium and zinc salts. The Diels-Alder reaction of levopimaric acid with maleic anhydride or male/c acid results in the formation of maleopimaric anhydride or acid and the (cis-) maleopimaric tricarboxylic acid (Soltes and Zinkel, 1989). Overall, these reactions involve Diels-Alder addition of a nucleophile such as maleic anhydride, maleic acid. The reaction products are isomer/c mixtures comprising (i) maleop/mar/c acid anhydride and (ii) (cis-) maleopimaric tricarboxylic acid.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Not expected to induce or elicit respiratory sensitization, with low potential for exposure due to low volatility.
Justification for classification or non-classification
Classified for skin sensitisation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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