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
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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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