Registration Dossier

Administrative data

Description of key information

Test results indicate that tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts; rosin, fumarated; rosin, fumarated, reaction products with formaldehyde; and rosin, maleated are irritating to eye but not to skin.

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

Results from investigations into the irritation (skin and eye) of tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts; rosin, fumarated;rosin, fumarated, reaction products with formaldehyde; and rosin, maleated are summarised briefly below:

 

Skin irritation

 

In a primary dermal irritation study, six young adult New Zealand white rabbits were exposed to 0.5 g of rosin, fumarated applied for 4 hours under semi-occluded contact to intact skin (Life Science Research, 1991b). 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, rosin, fumarated was not considered to be a skin irritant to rabbits, and presents a low skin irritation hazard. 

 

In a primary dermal irritation study, three New Zealand White rabbits were dermally exposed to 0.5 grams of rosin, maleated for 4 hours using a semi-occlusive dressing (Life Science Research, 1991a). Animals then were observed for 72 hours. Mean erythema and oedema scores were calcuated for the 24 to 72 hour time period. Mean erythema score (24 to 72 hours) was 0.1 and mean oedema score (24 to 72 hours) was 0. In this study, rosin, maleated is not a dermal irritant.

There were no studies identified for tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts; or rosin, fumarated, reaction products with formaldehyde. Instead, a read-across study conducted with tall oil, maleated was identified. In this study, six young adult New Zealand white rabbits were exposed to 0.5 g of Century PB 84 (tall oil, maleated) applied for 3 minutes (semi-occluded), 1 hour (occluded), or 4 hours (occluded) to intact skin (White Eagle Toxicology Laboratories, 1993). Mean erythema score 0.33 and a mean edema of 0 were calculated 48 hours after exposure. Based on these findings, Century PB 84 (tall oil, maleated) was not considered to be a skin irritant to rabbits, and presents a low skin irritation hazard. 

Eye irritation

There were no studies identified for tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts; rosin, fumarated, reaction products with formaldehyde; or rosin, maleated. One study was identified for rosin, fumarated. In this study the potential for rosin, fumarated (0.1 g) to cause eye irritation was evaluated after instillation into the eye of one New Zealand White rabbit (Life Science Research, 1991c). The animal was observed and then terminated 5 hours after application. After 5 hours, the substance was found to be a severe eye irritant, and further testing was therefore not warranted.

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 1.