Registration Dossier

Administrative data

Description of key information

Not irritating to skin but capable of causing severe 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

No key or supporting skin irritation studies are available for Fatty acids, tall oil, oligomeric reaction products with maleaic anhydride and rosin, calcium, magnesium salts. However, skin irritation data is available from a test conducted using structural analogue Rosin, maleated. No eye irritation study with Fatty acids, tall oil, oligomeric reaction products with maleaic anhydride and rosin, calcium, magnesium salts is available.  However, H4R consider that for local effects such as eye irritation, read across from Rosin, fumarated, is appropriate and may be considered to represent a worst-case scenario This information is summarised below.

Skin irritation

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 calculated 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 was not a dermal irritant.

Eye irritation

The eye irritation potential of Rosin, fumarated was evaluated after instillation of 0.1 g 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 skin irritation/corrosion: not irritating

Effects on eye irritation: Irritating

Justification for classification or non-classification

Fatty acids, tall oil, oligomeric reaction products with maleaic anhydride and rosin, calcium, magnesium salts is not classified for skin irritation according to UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Fatty acids, tall oil, oligomeric reaction products with maleaic anhydride and rosin, calcium, magnesium salts is classified Eye Irritation Category 1 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).