Registration Dossier

Administrative data

Description of key information

Not irritating to skin but capable of causing eye irritation. Low vapour pressure precludes inhalation exposure.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Adequate information exists to characterise the skin and eye irritation potential of Rosin adduct esters. These are formed after modification of rosin with either fumaric acid or maleic anhydride followed by esterification with glycerol and/or pentaerythritol, and hence the adduct ester products therefore exhibit close structural similarities. The available data includes results of tests conducted using Resin acids and rosin acids, fumarated, esters with glycerol, Resin acids and rosin acids, fumarated, esters with pentaerythritol and Resin acids and rosin acids, maleated, esters with pentaerythritol. This information is summarised below.

Skin irritation

In a primary dermal irritation study, six young adult New Zealand white rabbits were exposed to 500 mg of Bevilite 62-115 (Resin acids and rosin acids, fumarated, esters with pentaerythritol) applied for 4 hours under semi-occluded contact to intact skin (Centre International de Toxicologie, 1990). Methods used in this study were compliant with current guidelines (OECD 404). Animals were then observed for a period of 72 hours post-treatment. Irritation was scored. Mean erythema and edema scores for 24 to 72 hours were observed 0 in intact rabbit skin exposed to the test material under semi-occluded contact for 4 hours. Based on these findings, Bevilite 62-115 (Resin acids and rosin acids, fumarated, esters with pentaerythritol) was not considered to be a skin irritant to rabbits, and presents a low skin irritation hazard.

In a primary dermal irritation study, six young adult New Zealand white rabbits were exposed to 0.5 mL of UNI-REZ 757 (Resin acids and rosin acids, fumarated, esters with glycerol) applied for 24 hours under occluded contact to intact and abraded skin (Food & Drug Research Laboratories, Inc, 1985d). Animals were then observed for a period of 72 hours post-treatment and irritation was scored. Examinations at 24.5 and 72 hours post-treatment with the undiluted test substance moistened with saline indicated no signs of erythema or edema on the abraded or intact skin of the six rabbits. Based on these findings, UNI-REZ 757 (Resin acids and rosin acids, fumarated, esters with glycerol) was not considered to be a skin irritant to rabbits, and presents a low skin irritation hazard.

In a primary dermal irritation study, six young adult New Zealand white rabbits were exposed to 0.5 mL of UNI-REZ 7059 (Resin acids and rosin acids, maleated, esters with pentaerythritol) applied for 24 hours under occluded contact to intact and abraded skin (Food & Drug Research Laboratories, Inc, 1985c). Animals were then observed for a period of 72 hours post-treatment and irritation was scored. Examinations at 24.5 and 72 hours post-treatment with the undiluted test substance moistened with saline indicated no signs of erythema or edema on the abraded or intact skin of the six rabbits. Based on these findings, UNI-REZ 7059 (Resin acids and rosin acids, maleated, esters with pentaerythritol) was not considered to be a skin irritant to rabbits, and presents a low skin irritation hazard.

Eye irritation

In a primary eye irritation study, 0.1 gram of UNI-REZ 757 (Resin acids and rosin acids, fumarated, esters with glycerol) was instilled into the conjunctival sacs of each of six young adult New Zealand white rabbits (Food & Drug Research Laboratories, Inc, 1985f). The remaining eye of each rabbit served as a control. Ocular reaction for each animal was recorded at 24, 48, and 72 hours post-treatment and scored. The mean eye irritation score was determined for each observation period. The overall mean eye irritation scores (± S. D.) out of a possible 110 points were 21.5 (± 6.3) at 24 hours, 13.2 (± 3.9) at 48 hours, and 4.3 (± 3.3) at 72 hours. All treated eyes were normal by the 7-day examinations. Based on the scoring and classification systems in the study report, the test substance was considered to be irritating to rabbit eyes.

In a primary eye irritation study, 0.1 gram of UNI-REZ 7059 (Resin acids and rosin acids, maleated, esters with pentaerythritol) was instilled into the conjunctival sacs of each of six young adult New Zealand white rabbits (Food & Drug research Laboratories, Inc, 1985e). The remaining eye of each rabbit served as a control. Ocular reaction for each animal was recorded at 24, 48, and 72 hours post-treatment and scored. The mean eye irritation score was determined for each observation period. The overall mean eye irritation scores (± S. D.) out of a possible 110 points were 24.2 (± 5.0) at 24 hours, 11.3 (± 3.2) at 48 hours, and 4.2 (± 2.9) at 72 hours. All treated eyes were normal by the 7-day examinations. Based on the scoring and classification systems in the study report, the test substance was considered to be irritating to rabbit eyes.

Respiratory Tract Irritation

No studies were identified, however a low vapour pressure indicates that exposure via this route is unlikely.


Effects on eye irritation: irritating

Justification for classification or non-classification

Not classified for skin irritation 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). Classified for eye irritation 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), Eye Irritation Category 2.