Registration Dossier

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:

Adequate information exists to characterise the skin sensitisation potential of Rosin Adducts and Rosin Adducts Salts. These are formed when rosin reacts with maleic anhydride (or maleic acid) or fumaric acid yielding a maleated rosin adduct or a fumarated rosin adduct, respectively; the rosin adduct salts are simply the rosin adducts that have been reacted with an appropriate base. The available data includes results of tests conducted using Rosin, fumarated, Rosin, maleated and Rosin, fumarated, reaction products with formaldehyde. 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, fumarated in in acetone/olive oil 4:1 which was applied to the dorsal surface of each ear for 3 consecutive days (Safepharm Laboratories Limited, 2002). A control group received the vehicle only in the same manner. On Day 5, 3HTdR was injected into the tail vein, the auricular lymph nodes collected 5 hr later, and a single cell suspension prepared. 3HTdR incorporation by the cells was determined, and the Stimulation Index (SI) calculated for each dose of the test substance. The pooled Stimulation Index was 1.2, 7.0, and 12.8, respectively. Based on the results, Rosin, fumarated was a skin sensitizer in mice in an OECD 429 compliant study.

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 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, fumarated, reaction products with formaldehyde in acetone/olive oil 4:1 which was applied to the dorsal surface of each ear for 3 consecutive days (Safepharm Laboratories Limited, 2003). A control group received the vehicle only in the same manner. On Day 5, 3HTdR was injected into the tail vein, the auricular lymph nodes collected 5 hr later, and a single cell suspension prepared. 3HTdR incorporation by the cells was determined, and the Stimulation Index (SI) calculated for each dose of the test substance. The pooled Stimulation Index was 0.9, 3.0, and 7.2, respectively. Based on the results, Rosin, fumarated, reaction products with formaldehyde was a skin sensitizer in mice in an OECD 429 compliant study.

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.

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.

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).