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 acutely toxic following oral exposure (LD50 >2000 mg/kg bw). A low vapour pressure indicates that inhalation exposure is unlikely.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute Oral Toxicity
In a key Guideline (OECD 423) acute oral toxicity study (Phycher Biodeveloppment, 2010), a single dose of fatty acids, tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts was administered via gavage to six female rats were at a concentration of 2000 mg/Kg. One animal died prior to study termination. The only effects seen in the surviving animals were decreased spontaneous activity and piloerection in one animal at 24.5 h post dose. Body weight gain was normal and there were no macroscopic abnormalities at post mortem on completion of the study.The acute oral LD50 in this study was >2000 mg/kg bw for female rats.
Acute Dermal Toxicity
No studies were available for review. However, based on available acute oral toxicity data (LD50 >2000 mg/Kg), the acute dermal toxicity of the fatty acids, tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts is expected to be greater than 2000 mg/Kg. Therefore, this substance is not expected to pose an acute dermal toxicity hazard and is not classified under EU CLP for the same.
Acute Inhalation Toxicity
No studies were available for review, however a low vapour pressure indicates that exposure via this route is unlikely while results from test performed using oral exposure indicates no acute hazard.
Justification for classification or non-classification
Not classified for acute lethality by oral route of exposure under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
For non-EU countries, the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) defines a fifth category for acute toxicity for chemicals with oral LD50 values between 2000 and 5000 mg/kg/bw. Insufficient data were available to provide a definitive classification under UN GHS for acute oral toxicity. The physico-chemical properties of the substance indicate no requirement for classification with regard of aspiration hazard (substance is a solid).
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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